controlled release drug delivery system - asm international

BOX 19031, 500 W. FIRST ST., 325 WOOLF HALL, ARLINGTON, TEXAS 76019-0031 T 817-272-2398 F 817-272-2538 http://www.uta.edu

THE UNIVERSITY OF TEXAS AT ARLINGTON MATERIALS SCIENCE AND ENGINEERING

06-13-2011 Ms. Jeane Deatherage Administrator, Foundation Programs Materials Park, OH 44073

RE: Undergraduate Design Competition Dear Jeane: I am pleased to inform you that the Undergraduate Design Competition Submission entitled “Controlled Release Drug Delivery System” by Letia Blanco, Christopher Alberts, Kyle Godfrey, Andrew Patin and Chris Grace is the only one from the Materials Advantage-University of Texas at Arlington Chapter. The students have committed to make sure that in the event that they win the competition at least one of them will come to the MS&T meeting this fall. If you have any questions please do not hesitate to contact me. Best wishes.

Sincerely yours,

Pranesh B. Aswath Ph.D. Professor and Associate Chair Faculty Advisor: Materials Advantage-University of Texas at Arlington Materials Science and Engineering Department University of Texas at Arlington Arlington, TX 76019 817-272-7108 [email protected]

eam Members

2011

Team Members Letia Blanco Christopher Bryan Alberts Kyle Godfrey Andrew Patin Chris Grace Advisors Dr. Shiakolas Dr. Aswath Correspondence Address

2620 Bauer Drive Denton TX 76207

Table of Contents

Executive Summary 1

Report Body Introduction 1 Device Design 3 Analytical Thermal Model 13 ANSYS IcePak Finite Element Model 19 Release Rate Testing 23 Project Conclusions and Recommendations for Future Projects 27

Appendices Appendix A: Fabrication Processes Appendix B: Bibliography Appendix C: Dimensioned Drawings Appendix D: Material Data Sheets

1

Executive Summary

Half a million people in America seek medical treatment for burns every year and for

40,000 of them, their injuries are severe enough to require hospitalization. Treatment of these

very painful injuries consists of applying multiple topical medications to fight bacterial infection,

keep the wound moist, reduce pain and stimulate tissue growth. This often requires that the

wound dressing be opened multiple times a day. This process is extremely uncomfortable for the

patient and it exposes the wound to the environment, significantly increasing the chance of

infection. If a system could be designed to increase the amount of time between dressing

changes, both pain and the likelihood of infection could be reduced.

The Controlled Release Drug Delivery Device is specifically designed to increase the

amount of time between wound dressing changes. This goal is accomplished through the

implementation of two key concepts. We use a hydrogel that can be both hydrophilic and

hydrophobic depending on its temperature, by controlling the temperature of the hydrogel using

thermoelectric devices we are able to both heat and cool the hydrogel when necessary, ensuring

excellent temperature control and thus controlled drug delivery. Our bandage consists of many

separate modules capable of distributing multiply medication all on their own time schedule.

These modules are connected by a flexible plastic allowing the bandage to comfortably conform

to any wound. A lateral wiring scheme allows for bandage size customizability and removable

medicine trays allows spent hydrogel to be removed and the electrical components sterilized,

then recharged and reused.

We have created a device that offers controlled delivery of multiple medications without

the removal of wound dressings. We believe this device will be a profitable product that will

reduce infections, diminish patient discomfort, shorten hospital stays, lessen medical costs and

save lives.

Introduction

Background and Motivation Every year approximately 500,000 Americans

receive treatment for burn related injuries. 40,000

Americans require hospitalization and 24,000 require

treatment at specialized burn care facilities (American

Burn Association). For the vast majority of these

individuals a long and painful process is required for the

treatment and healing of the wounded areas.

The wound site is very sensitive to any amount

of stimulation. This means that every time the wound is

inspected and subsequently dressed, the patient must

endure a large amount of pain. Since dressing changes Figure 1 - Example of Wound, Appropriate Application for our Bandage

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must be made on a very regular basis, every 8-12 hours, the treatment process becomes a never-

ending struggle with pain.

The second problem in burn wound treatment is the risk of bacterial infection. On

average bacterial infection accounts for between 50-60% of all deaths in burn patients (Sally

Abston MD). Bacterial infection is often prevalent in burn victims due to a combination of dead

tissue, a weakened immune system and the destruction of the skin's barrier to infection. This

allows bacteria to penetrate deep into the skin and permits travel through the lymph system.

Physicians are forced to inspect the wound site on a regular basis to ensure that burn wounds are

not becoming infected. Repeated wound inspection exposes the wound site to potential infection

causing contaminants.

Along with painful treatment, burn victims must also deal with large financial burden. In

1992, a burn that covered 30% of the victims’ body could cost around two hundred thousand

dollars to treat. The average cost of burn related hospitalization was $17,300 versus $9,000 for

all other types of stays. The average hospital stay for burn patients was 8.9 days versus 5.1 days

for all other types of patients (United States Department of Labor). If we can create a device that

can improve the effectiveness of burn treatment, we can save lives, lessen suffering, shorten

hospital stays and save money.

A New Approach

The MicroMed Controlled Release Drug Delivery Devise has been designed to be a new

approach to burn wound and skin graft donor site management. With this device the patient will

experience a much less traumatic rehabilitation process due to a reduced amount of pain during

treatment as well as a reduced likelihood of infection. The devise accomplishes this task by

allowing a longer period of time to pass between

dressing changes.

The MicroMed Controlled Release Drug

Delivery Devise is a drug release mechanism which

offers the medical practitioner complete control over

the drug time rate of release. It is a modular device

which can be custom sized for individual burn wound

needs. It consists of individual modules that are

loaded with medications to treat the wound. Refer

Figure 2 Drug Delivery Device. Each module allows

the operator to choose exactly when, how long and at

what intensity the drug is released. When the module

has delivered its entire drug supply it can be reloaded

with a fresh supply of drugs.

The MicroMed Controlled Release Drug Delivery Device is a significant breakthrough in

the way burn wounds and skin graft donor sites could be treated. By allowing physicians to

effectively treat wounds in a much less invasive way this devise promises to reduce pain and

infection and give patients higher levels of comfort during treatment than they have ever had

before.

Figure 2 Drug Delivery Device

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Device Design

The purpose of our design is to produce a flexible bandage that can release multiple medications

on any time schedule determined by a doctor. Figure 3 Bandage Visualizing Multiple

Medication Placement and Release Control, imagine the blue modules could be releasing an

antimicrobial every hour, the yellow modules a growth hormone every four hours and the green

modules could be releasing a pain killer continuously. In general,

we determined that any good design would need to:

1. Allow for significant customizability, both in the shape

and size of the bandage and the specific configuration of

medication within the device

2. Be easy to manufacture by minimizing the number and

complexity of individual parts while incorporating

available materials and off the shelf parts

3. Be robust enough to survive transport and use

4. Be comfortable for the patient and easy to use

Thermally Responsive Hydrogel

The fundamental building block of our design is a thermally responsive composite hydrogel.

This Composite Hydrogel consists of

four parts:

Thermally responsive polymer

Therapeutic nanoparticles

Photo-initiator Irgacure 2959

Matrix polymer

Poly[N-isopropylacrylamide-co-

acrylamide] PNIPAM-AAm) is our

thermally responsive polymer, it can

be loaded with drugs and experiences a

phase change at a lower critical

solution temperature (LCST). Below the

LCST the PNIPAM-AAm is hydrophilic,

allowing it to be loaded with an aqueous solution containing therapeutic nanoparticles. In our

device this could be antimicrobial agents, analgesics or growth hormones for wound treatment.

When exposed to temperatures above the LCST, the PNIPAM-AAm becomes hydrophobic and

rejects the aqueous solution of medication into the surrounding hydrogel at which time the

medicine travels by diffusion to the wound site. The acrylamide was added to increase the LCST

from about 80 °F to about 100 °F, thus ensuring that normal contact with skin would not be

enough to activate the medication release. The temperature sensitive polymer, PNIPAM-AAm, is

impregnated with medicine and is then mixed with a photo-initiator, Irgacure 2959, and a matrix

Figure 4 Description of Thermally Responsive Composite Hydrogel (Sabnis)

Figure 3 Bandage Visualizing Multiple Medication Placement and Release Control

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polymer. Poly[ethylene glycol] diacrylate (PEGDA) was chosen as the matrix polymer for its

cross linking abilities. Next, this mixture is

exposed to UV light, resulting in a gelatinous

substance subsequently referred to as the

Composite Hydrogel. Please see Figure 4

Description of Thermally Responsive

Composite Hydrogel (Sabnis). For more

information on the fabrication of the

hydrogel please see Appendix A: Fabrication

Processes.

When held continuously at a temperature

above the LCST, the therapeutic

nanoparticles experience three types of

release phases. The Initial Burst Phase,

usually completed in the first hour, is the highest rate of release. The second phase, Sustained

Burst, lasts usually 1-8 hours and is significantly slower than the Initial Burst release. The last

phase is the Plateau Release phase, which is a period of very small but still continuing release.

Please see Figure 5 Example Graph of Drug Release Rates (Sabnis). By instead exposing the

hydrogel to cycles of heating and cooling, we minimize the amount of medication released

during the burst phase, thus enabling “uniform doses”.

Hydrogel Containment Chamber

In order to enable individual control, about .062 cm3 of Composite Hydrogel is held in separate

containment chambers, each tray containing a single medication.. Stainless Steel was chosen as

the chamber material due to its excellent thermal conductivity, its biocompatibility, its ability to

be sterilized and its established ubiquity in medical devices. (Note: due to material availability,

containment chambers in the proof of concept

prototype were made from Aluminum.) Holding

the hydrogel in a container that can be removed

from the overall device allows us to easily photo-

polymerize the Composite Hydrogel directly in the

tray, ensuring repeatable shape and volume. In tray

photopolymerization also results in a small amount

of adherence between the hydro gel and the walls

of the tray, helping to prevent the hydrogel from

shifting within the device. These removable trays

could allow the doctor to easily recharge their

bandage with disposable medicine trays while

allowing the more expensive electrical components

to be sterilized and reused. For more information

on tray fabrication, please see Appendix A:

Fabrication Processes. For a dimensioned drawing

of the tray, please see Appendix D: Dimensioned Drawings.

Figure 5 Example Graph of Drug Release Rates (Sabnis)

Figure 6 - Tray with Composite Hydrogel

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Temperature Regulation using Thermoelectric Devices

To control the release of the medication, we must be able to control the temperature of the

hydrogel. Each tray containing Composite Hydrogel is heated to release temperatures by contact

with a thermoelectric device (TED). Thermoelectric devices take advantage of the Peltier effect

to move heat both with, and more importantly against a temperature gradient. N-type and P-type

semiconductors are wired in series and sandwiched between two ceramic plates. Due to their

solid-state construction, thermoelectric devices are dependable. They are also available in very

small sizes and they have sufficient heating and cooling capabilities. Thus, each cavity of

Composite can be controlled individually. Thermoelectric devices act as reversible heat pumps.

If current is passed through the thermoelectric in one direction, the thermoelectric will function

as a heater see Figure 7 – Thermoelectric Device as a Heater. If current is passed through the

thermoelectric in the opposite direction, it will function as a cooler; see Figure 8 -

Thermoelectric Device as a Cooler. For more information about the thermoelectric device we

have chosen, see Appendix C: Material Data Sheets.

Alignment Structure

Each thermoelectric device and tray of hydrogel fits into a poly(methyl methacrylite) or PMMA

insert. This insert provides rigidity while ensuring that the thermoelectric and the tray of

hydrogel remain properly aligned during use. The sub-assembly the tray of Composite Hydrogel

in contact with the thermocouple and the TED, all inside the PMMA insert will subsequently be

referred to as a Module. For an exploded view, please see Figure 8 - Module Exploded View. For

an assembled view, please see Figure 7 - Module Collapsed View. For a photo of a fabricated

module please see Figure 9 - Completed Module. For the manufacturing processes used in the

fabrication of the PMMA insert, please see Appendix A. For more information on PMMA,

Figure 7 – Thermoelectric Device as a Heater Figure 8 - Thermoelectric Device as a Cooler

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please see the Material Data Sheet in Appendix C. For an engineering drawing of the PMMA

insert, please see Appendix D.

Connecting the Modules Each individually controlled module fits into a cavity of a housing made from

polydimethylsiloxane (PDMS). This strong, flexible material is common in biomedical

applications. Connecting the rigid modules with this flexible material reduces the rigid footprint

of the device allowing the

bandage to conform to the

wound. This separation between

modules also reduces heat

bleeding between cavities,

allowing each module to heat and

cool properly no matter the

temperature of the surrounding

modules. For information about

PDMS, see its Material Data

Sheet in Appendix C. For the

fabrication process, please see

Figure 11 - Lateral Wiring Scheme

Figure 10 - Variable Length Bandage

Figure 8 - Module Exploded View

Figure 7 - Module Collapsed View

Figure 9 - Completed Module

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Appendix A. For an engineering drawing of the PDMS Casing please see Appendix D. Each

module will be wired laterally into strips several modules long. Each of these strips would be

independently wired so the bandage could be cut in between strips without compromising the

integrity of the wiring. The width of the

bandage is fixed by the number of modules in

a strip, but the length of the bandage is

customizable to the size of the treatment site.

See Figure 10 - Variable Length Bandage and

Figure 11 - Lateral Wiring Scheme. Each

module has the wires from the thermocouple

and the wires to the thermoelectric each will

meet at a connection pin that will plug into a

variable length wiring harness that will

connect to a battery operated portable

controller. Thus, this bandage could work in

any situation from the hospital setting to a

soldier in the field.

Closed Loop Control System

Figure 13 - Control Diagram

SBC -68 Connecting Block

3 IC H-Bridges

3 Devices

12V Power Supply

Figure 12 - PDMS Casing with Single Module

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Our control system hardwarde includes a 12V power supply capable of delivering 4A, an IC H-

bridge to allow for current switching and voltage control, thermocouples to read the temperature

and a National Instruments SCB-68 connecting block to allow for wire connection to the NI PCI-

6221 DAQ card installed in a Dell Optiplex 745 PC running Windows XP SP3 with LabVIEW

2010. One 40 gauge K Type bi-metallic thermocouple is inserted in between the thermoelectric device

and the tray of hydrogel and held in place by thermal epoxy. Another thermocouple is inserted

directly into the tray of hydrogel. First the thermocouple feeds back the voltage, which is

converted to a temperature via a calibration curve. The raw thermocouple data was then

compressed at a rate of twenty to one, reducing the number of data points being recorded. The

compressed signals were then linked to a graph in order to monitor the temperatures. In addition

to a graph the data is written to an excel file to monitor the temperature history of each module

during testing. If the temperature is outside the desired range, LabVIEW will send the signal to

an IC H-bridge which changes the direction of current flow through the thermoelectric device

enabling heating or cooling.

The IC H-bridge has two inputs to control its

behavior. The first input, on pin 3, controls

whether the H-bridge passes current in one

direction (5V applied by LabVIEW), or the

other direction (0V applied by LabVIEW);

this current direction switching is what

allows the user to select heating or cooling

via the computer. The second input, on pin

4, controls whether the H-bridge is allowing

current to pass or not; this on / off capability

acts as a relay allowing us to electronically

cycle the device on and off.

Figure 14 - IC H Bridge

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Figure 15 - IC H Bridge on solderless breadboard

The user selects either heating or cooling on the front panel; these buttons choose whether the

heating or cooling logic statement is used for each device. By cycling the thermoelectric device

on and off a fairly uniform hydrogel temperature is produced.

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Figure 16 - LabVIEW block diagram

Figure 17 - LabVIEW front panel

11

The following graphs show heating and cooling data from the excel file that is written at the end

of each test. The yellow shaded areas show the desired temperature range. The horizontal red

line shows the temperature the logic was set to toggle at in LabVIEW. The blue line is the

thermoelectric

device, notice it

changes

temperature very

quickly. The green

line is the

temperature of the

hydrogel, notice it

reaches the desired

temperature more

slowly. Once the

hydrogel reaches

the desired

temperature the

thermoelectric is

turned off; when

the hydrogel returns

to a temperature

outside of the logic

temperature the

device

thermoelectric is

turned back on.

This toggling logic

allows us to cycle

the device on and

off to maintain a

desired tray

temperature within

just a few degrees.

Figure 19 - Heating Test of Single Module

Figure 18 - Cooling Test of Single Module

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Analytical Thermal Model This thermal model was created in order to:

1. Increase our understanding of thermoelectric device functionality

2. Determine if a heatsink is necessary. If so, predict the minimum size requirements

3. Evaluate how the device will perform over a range of input currents and select the most

appropriate application current.

The non-intuitive behavior of the thermoelectric devices led to an interesting analytical thermal model. The following equations describe how heat flows into the cold side and out of the hot side of the device . As demonstrated by the following equations, heat flow is a function of applied current, Seebeck Coefficient, thermal conductivity and electrical resistivity (thus Joule Heating) of the internal materials. Where Qh is the heat flow from the hot side of the thermoelectric, Qc is the heat flow into the cold side of the thermoelectric, Th is the temperature of the hot side of the thermoelectric, Tc is the temperature of the cold face of the thermoelectric and I in the input current.

Approximate material properties:

𝑄𝐻 = 𝛼𝑃 − 𝛼𝑁 𝐼𝑇𝐻 − 𝐾 𝑇𝐻 − 𝑇𝐶 +1

2𝐼2𝑅

𝑄𝐶 = 𝛼𝑃 − 𝛼𝑁 𝐼𝑇𝐶 − 𝐾 𝑇𝐻 − 𝑇𝐶 −1

2𝐼2𝑅

,P P N N P P N N

P N P N

A A L LK R

L L A A

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Number of couples, N: 17 Element width (in), W: 0.025 Element length (in), L: 0.040

We modeled the thermal path from the interior of the body, through the skin, through the device and passing into the surrounding air.

Figure 20 - Exploded View of Thermal Path and Corresponding Thermal Resistance Diagram

For steady state, the amount of heat flowing from the body through the device and into the thermoelectric device had to be equal to Qc, the heat flow into the thermoelectric. And the heat flow out of the thermoelectric Qh had to be equal to the heat flow through the heat sink and into the air. Thus we were able to write a pair of simultaneous equations, one for each face of the thermoelectric device.

h𝐴𝐻𝑒𝑎𝑡𝑆𝑖𝑛𝑘 𝑇𝑇𝐸𝐷 ℎ𝑜𝑡−𝑇𝑠𝑢𝑟𝑟𝑜𝑢𝑛𝑑𝑖𝑛𝑔𝑠 = 𝑁 𝛼𝑃 − 𝛼𝑁 𝐼𝑇𝐻 − 𝐾 𝑇𝐻 − 𝑇𝐶 +1

2𝐼2𝑅)

𝑁 𝛼𝑃 − 𝛼𝑁 𝐼𝑇𝐶 − 𝐾 𝑇𝐻 − 𝑇𝐶 −1

2𝐼2𝑅) =

1

𝑅𝑒𝑞𝑢𝑖𝑣𝑎𝑙𝑒𝑛𝑡 (𝑇𝑏𝑜𝑑𝑦 − 𝑇𝑇𝐸𝐷 𝑐𝑜𝑙𝑑

⬚

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Note: Rresultant was the equivalent resistance of the skin and device up to the cold face of the thermoelectric device. After substituting in the material properties, we were left with two equations and four unknowns; the area of the heat sink, the applied current, the temperature of the cold face of the thermoelectric and the temperature of the hot face of the thermoelectric. By substituting a range of values for the independent variables, heat sink area and applied current, we were able to solve for the temperatures of the thermoelectric faces. We then used this information to calculate the speed of heat flow for the given configuration and used this to calculate the maximum temperature experienced by the hydrogel. In order to visualize the results, we wrote the following Matlab program: % One dimensional conduction from skin to TED T_body=308; % K body temperature A=.000044; % m^2 cross sectional area, all faces are equal area k1=.3; % w/mk thermal conductivity of human skin/fat L1=.003; % m thickness of human skin/fat R1=L1/(k1*A); % resistance through skin/fat

k2a=.15; % w/mk thermal conductivity of PDMS k2b=.56; % w/mk thermal conductivity of water L2=.002; % m length of composite PDMS/Water layer R2a=L2/(k2a*.5*A); R2b=L2/(k2b*.5*A); R2=1.0/(1.0/R2a+(1.0/R2b)); % resistance through parallel water and PDMS

k3=.56; % w/mk thermal conductivity of water L3=.003; % m length of hydrogel layer R3=L3/(k3*A); % resistance through hydrogel

k4=237; % w/mk thermal conductivity of Aluminum L4=.5; % length of Aluminum layer R4=L4/(k4*A); % resistance through Aluminum

Req=R1+R2+R3+R4 ;% equivalent resistance from skin to TED

% Heat transfer to/from the TED ap_minus_an=.00043; % V/K Seebeck Coefficient lam_p=1.4; % W/mK thermal conductivity lam_n=1.4; % W/mK thermal conductivity rho_p=1*10^-5; % Ohm-meter electrical resistivity rho_n=1*10^-5; % Ohm-meter electrical resistivity N=17; % Number of elements Ew=.000635; % m width of element (I think the element is square so this is the width

and length) Ap=Ew*Ew; % m^2 P element area An=Ew*Ew; % m^2 N element area El=.001016; % m length of element (I think this is actually the height) K=((lam_p*Ap)/El)+((lam_n*An)/El); % w/mK thermal conductivity of TED R=((rho_p*El)/Ap)+((rho_n*El)/An); % Ohms

% Convection from the face of the TED to the air h=15; % w/m^2K convection coefficient for free convection over TED face

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T_sur=296; % K temperature of surrounding air A_heatsink=.000044; % m^2 initial value for area of heatsink

% defining variables for the hydrogel R_hydro=R1+R2; % resistance between body and hot side of hydrogel T_hydro_max=0; % initializing the max hydrogel temperature

% setting up the 2 simultaneous equations % h*A_heatsink*(Th-T_sur)=N*(ap_minus_an*I*Th-K(Th-Tc)+.5*(I^2)*R); % (T_body-Tc)/Req=N*(ap_minus_an*I*Tc-K(Th-Tc)-.5*(I^2)*R); % rearranging to find Cx=D

% I=input current in amps I=0;

% Th=temp of TED hot side Th=0; % initializing Th

% Tc=temp of TED cold side Tc=0; % initializing Tc

% establishing looping vector loop=linspace(.01,2, 100); % 250); loop2=linspace(.0022,.004, 100); % 250); Heat_Sink_Array=[]; QQ=[]; mydata=[]; l=0; for I=loop % increasing current %Icount=Icount+1; Heat_Sink_Vector=[]; Qloss = []; Theat_cold =[]; l=l+1; k=0;

for A_heatsink=loop2 % increasing Area C1=h*A_heatsink-N*ap_minus_an*I+N*K; % coefficient of Th in first equation C2=(1.0/Req)+N*ap_minus_an*I+N*K; % coefficient of Tc in second equation C=[C1,-N*K; -N*K, C2]; % coefficient matrix D=[((N/2.0)*I^2*R+h*A_heatsink*T_sur); ((N/2.0)*I^2*R+(T_body/Req))]; X=C\D; % solving for Th and Tc T_hydro_max=T_body-(T_body-X(2))*(R_hydro/Req); Q=(1/Req)*(T_body-X(2)); mydata=[mydata; I, A_heatsink, X(1)-273, X(2)-273, T_hydro_max-273, Q]; k=k+1; Temp(k,l)=[T_hydro_max-273]; end % end for heatsink loop fprintf('I value %f \n', I) end % end for temp max loop

% Generate 3-D plot of current, surface area and Temp [x,y]=meshgrid(loop,loop2); surf(x,y,Temp); xlabel('Current (Amps)') ylabel('Surface Area (m^2)') zlabel('Temp (C)') AZ=130; EL=30; view(AZ,EL);

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Which produces the following graph:

Figure 21 - Maximum Hydrogel Temperature as a function of Heat Sink surface area and Input Current

As we would expect, as the surface area of the heatsink increases, heat is expelled more easily

and the maximum temperature of the hydrogel diminishes. Also as expected, low input current

results in insufficient cooling. But counter intuitively, increasing input current does not continue

to improve cooling. We had expected a thermoelectric device cooling at “full blast” maximum

input current to produce maximum cooling, but instead we see that as the input current increases

past a certain range, Joule Heating begins to overpower the Peltier Effect and the maximum

temperature in the hydrogel begins to rise dramatically.

This analysis process was repeated for a module in contact with our PMMA testbed. When the

convection coefficient produced by a small electronics fan was assumed to be 12 W/m2K this

model predicted hydrogel temperatures that were within 2 degrees of experimentally measured

values.

Conclusions from Analytical Thermal Model

• A heat sink will be necessary to adequately cool our device

• The heat sink should have a minimum surface area of at least .0022m2

• For very low or very high input current Joule Heating over powers the Peltier Effect

and the steady state temperature of the hydrogel rises dramatically

• For coolest hydrogel, input current should be .8A-1.2A

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ANSYS IcePak Finite Element Analysis

Introduction

A model of our device

was created in ANSYS IcePak

to the geometric specifications

detailed in our CAD model,

but disregarding internal radii,

ledges and small geometric

features that were unlikely to

have a significant impact on

the device temperature profile.

A rendering of the device

assembly is shown in Figure

22 - Device, Test bed and Heat

Sink in ANSYS IcePak. Our

first step was to calibrate the model by first modeling the device in contact with the test bed and

then comparing the temperatures predicted by ANSYS IcePak to those measured experimentally.

We then used the model to investigate how proximity of heating and cooling modules affected

hydrogel temperature and lastly to predict how the hydrogel temperature would be changed

when, instead of the test bed, the device was in contact with skin.

Model Setup

In our IcePak Model we placed the

assembly in a 0.1 m x 0.1 m x 0.1 m cabinet

open on all sides except for the bottom

surface, thus mimicking our device and test

bed sitting on a table. Air was forced over the

assembly’s heat sinks from a position that

was very close to where we had placed a

small electronics fan. The heat sinks were

modeled realistically but were simplified

slightly. The thermoelectric devices used in

the actually model were created using a

macro native to the IcePak program in

conjunction with data that we received from

the manufacturer. The thermoelectric macro

was one of the primary reasons that we chose

to analyze our device in IcePak instead of

another Finite Element Analysis program due

to the ease of creating an accurate model of a

Figure 23 - IcePak Model Setup

Figure 22 - Device, Test bed and Heat Sink in ANSYS IcePak

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thermoelectric in this program. This macro allowed us to identify a number of characteristics of

the thermoelectric including material

properties, size and number of

couples and applied current.

Results and Discussion

TEST 1

We began by mimicking our

test bed set up, with the theroeoelctric

experiencing 1A input current, and

adjusted the cubic flow rate of the

fan within reasonable values until the

steady state cooling value of the

hydrogel was sufficiently close to

experimentally measured values. The

results of this model can be seen in

Figure 27 - Three Modules

Experiencing Cooling. Since the

purpose of our Finite Element

Analysis was to COMPARE how

proximity between modules

influences temperature, we argue that

this initial calibration to ensure that

three modules experiencing cooling

closely matched experimental values

was appropriate.

Figure 24 - Screen Shot of Thermoelectric Device Macro in ANSYS IcePak

Figure 27 - Three Modules Experiencing Cooling

Figure 28 - Steady State Experimental Data compared to Calibrated IcePak Predictions

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TEST 2

We then ran another test where

the central module remained in a

cooling state and the modules adjacent

to it were heated. While we continued

to apply 1A to the cooling module, we

applied a reduced current to the

heating module. Our control system

switches on and off to hold this steady

temperature and this on/off results in

an average input current which is less

than the maximum current that would

be applied if held “on” continuously.

Again, the purpose of our FEM model

was to evaluate the effects of heat bleeding, thus it was appropriate to place our cooling module

close to heated modules that would be producing the same amount of heat as heated modules

being controlled by our control system. As can be seen in Figure 25 - Cooled Module in

Proximity to Two Heated Modules, this configuration resulted in an increase in steady state

cooling temperature of the hydrogel of 6 degrees Fahrenheit. This steady state cooling value can

be interpreted as the coolest possible temperature with a thermoelectric device running

continuously. A steady state cooling temperature of 63 °F means that our control system could

cycle on and off and produce a cold temperature of 63 °F or greater. Thus although there was a

small increase in the temperature of the hydrogel this value is still more than 44 °F below the

LCST of the hydrogel.

TEST 3

The last model replaced the

test bed with a representation of

human skin. Human skin was again

modeled as it was in the Analytical

Thermal Model, as a constant internal

body temperature of 96°F, with a

3mm layer of fat with a thermal

conductivity of .3 W/mK. This test

was performed to determine if the

cooling provided by the

thermoelectric devices would be

sufficient to keep the hydrogel

temperature below the LCST. The

results of this test can be seen in

Figure 26 - Three Cooled Modules in Contact with Skin. The average temperature of the

hydrogel was increased to 70°F. Although contact with the body did significantly increase the

temperature of the hydrogel, this higher temperature was still more than 37 °F below the LCST,

the temperature at which the hydrogel experiences the phase change which results in rapid

Figure 25 - Cooled Module in Proximity to Two Heated Modules

Figure 26 - Three Cooled Modules in Contact with Skin

22

medication release. This large margin proves that our chosen thermoelectric devices will be able

to sufficiently cool the hydrogel even when the device is in contact with skin.

Conclusions from the ANSYS IcePak Thermal Model

• 1 A applied current for cooling, adjusted cubic flow rate of small electronics fan and

reduced applied current to mimic control system heating accurate predict the

behavior of our device

• Heat bleeding between modules does occur, but is very small and although it

increases the steady state cooling temperature of the hydrogel, this temperature is

still 44°F below the LCST of the hydrogel

• Contact with skin further increases the steady state cooling temperature of the

hydrogel, but this increased temperature is still 37°F below the LCST of the

hydrogel.

• Our device has significant margin between steady state cooling hydrogel

temperature and the LCST, thus we predict that even when near to heating modules

and in contact with skin, our thermoelectric devices will be powerful enough to

keep the hydrogel below release temperatures.

23

Release Rate Testing

Motivations for Release Rate Testing 1) Confirm that our control system can properly heat the hydrogel to induce protein release

2) Investigate how protein release rate changes as concentration in the hydrogel diminishes

3) Investigate how protein release rates can be manipulated by applying cycles of heating and

cooling

Experimental Procedure 1) 80 µL of this Composite Hydrogel Solution was pipetted into the aluminum tray and photo-

polymerized under UV light for 3 minutes

2) 0.3 mL water injected into each cavity of the test bed

3) Modules with hydrogel inserted through the top of the PDMS casing

4) Artic Silver thermal epoxy and heat sink applied to the thermoelectric surface

5) After each test session, all water removed from testbed and stored and test bed was refilled

with fresh water

6) BCA assay used to characterize protein release

a) Calculated absorbency of samples in spectrometer at 562 nm wavelength

Two Modes of Diffusion 1) The protein is released from the PNIPAM-AAm

a) Cause: The PNIPAM-AAm becomes hydrophobic above the LCST

2) The protein makes its way through the hydrogel

a) Cause: Concentration gradient

Thus we would expect to see a delay between when the protein is released from the PNIPAM-

AAm and when it actually exits the hydrogel

In many ways the culmination of this project was the medication release testing. Only by

demonstrating that our device could actually induce and control the release of medication from

the hydrogel could we conclude that our device worked. From these tests we hoped to

demonstrate a few key concepts. First, we simply wanted to demonstrate that by using our device

to heat and cool the hydrogel we could influence the way medication was released. Second, we

wanted to develop a relationship between the amount of medication in the device and the

medication release rate. And finally, we wanted to demonstrate that we could produce a desired

release profile by manipulating the way we applied heating and cooling to the hydrogel. To

conduct these tests we fabricated a test bed capable of holding three modules at one time. Each

module was held over a chamber filled with water so that when it released, the medication would

be captured in the chamber. Each chamber was isolated from the other two chambers so that we

could measure the release from each module. To begin a test we would load each module with a

hydrogel impregnated with Bovine Serum Albumin. For each sample, we would remove the

water in each chamber and replace it with fresh water, this would allow us to track the change in

release rate as a function of time as well as other variables.

24

TEST 1

For our first test we wanted to determine a baseline release for our hydrogel samples. In theory

we would love to see that the hydrogel did not release any medication until it was brought above

the critical temperature. Unfortunately from the literature we knew that this was not the case and

we should

expect to see

some release

below the

critical

temperature.

The purpose

of the first test

was to

quantify this

uncontrollable

release. To do

this we loaded

a module with

BSA and let it

sit at room

temperature

for 7 hours.

The results of

this test were

that we saw

about 12.8% of the

total medication in the

hydrogel released. The next step for us was to conduct this same test except with the hydrogel

held above the critical release temperature, remember this should cause the hydrogel to release

the medication. For this test we held the device at approximately 107°F. After conducting this

experiment we saw that 38.8% of the total medication in the device had been released. Seeing

that the amount of medication released was significantly greater in the heating test than it was in

the room temperature test, we concluded that our device was causing the hydrogel to release.

With a positive result from our first test we were able to move on to our next set of testing. See

Figure 27 - Cumulative Protein Release for Heated and Room Temperature Control, for test

results.

TEST 2

For our next test we wanted to see what effect cycling the device above and below the critical

temperature would have on medication release. To do this we loaded each module with

medication and then held the device at approximately 107°F for 30 minutes followed by holding

the device at approximately 68°F for 90 minutes. We continued with 30 minutes of heating, 90

minutes of cooling and finally 30 minutes of heating. Every 30 minutes we changed the water in

Figure 27 - Cumulative Protein Release for Heated and Room Temperature Control

25

Figure 28 - Protein Release in Response to Uniform Heating/Cooling Cycle

the capture chambers

so that we could

measure the release in

30-minute intervals.

What we found was

that our greatest

amount of release

occurred during the

first 30 minutes,

which corresponded to

the first 30 minutes of

heating. During the

next 90 minutes of

cooling we continued

to measure release,

however it decreased

over this time period.

During the next

heating we again saw

an increase in the

medication release;

however this release was

less than the amount we

saw in the first heating cycle. During the next 90 minutes of cooling we again saw release at a

decreasing rate and during the final heating cycle we saw a very small increase in the amount of

medication released. We were able to make two major conclusions from this test. First, we were

able to see that while the medication was released during the heating portion of the test a

significant amount of time was required for the medication to diffuse out of the device and into

the capture chambers. This delayed response is why we saw the decreasing amount of release

throughout the cooling portions of the test. The second conclusion we were able to make was

that overall rate of medication release is a function of the concentration of medication in the

device. When the concentration is high in the beginning, 30 minutes of heating produces a large

release, but when the concentration is low, near the end of the test, the 30 minutes of heating will

produce a much smaller release. See Figure 28 - Protein Release in Response to Uniform

Heating/Cooling Cycle, for release results.

TEST 3

For our third and final test we wanted to try to show that by adjusting the duration of the heating

cycle we could minimize the initial burst release and produce a fairly even amount of medication

release for each heating cycle. To accomplish this we decided to decrease the amount of initial

release by making our first period of heating last for only 15 minutes. This heating was followed

by 90 minutes of cooling. The second heating was applied for 30 minutes, twice as long as the

initial heating. This was followed by 90 minutes of cooling. Finally we applied heat for 45

minutes, three times as long as the initial heating. What we saw from this test was a much more

26

uniform release

profile. By

beginning with

heating for a short

period of time and

increasing it for

each subsequent

period of heating we

were able to balance

the release

throughout the test

much more

effectively. From

this we concluded

that we could

manipulate the

release profile by

changing the way

we applied the

heating and cooling

cycles. See Figure

29 – Protein Release in

Response to Non-

Uniform Heating/Cooling Cycle, for release results.

Conclusions from Release Rate Testing

• Heating the hydrogel indeed resulted in increased BSA release when compared to

room temperature control

• Two types of diffusion are present. Release of BSA from the PNIPAM-AAm

caused by phase change at LCST and also release of BSA from device which is also

a function of the protein concentration within the device. This results in initial

burst release and a delay between the cessation of heating and the significant

diminishment of release.

• Temperature cycling will impact medication release profile

• Release rate diminishes as total concentration of protein within the device

decreases. Thus shorter heating cycles at the beginning of medication release and

longer heating cycles when the concentration had been diminished can result in

more uniform release doses.

Figure 29 - Protein Release in Response to Non-Uniform Heating/Cooling Cycle

27

Project Conclusions and Recommendations for Future Projects

Project Conclusions

• Material design consideration led to thermally responsive hydrogel capable of medicine

impregnation, stainless steel tray that was thermally conductive and capable of being

sterilized. The epoxy was chosen for thermal conductivity and biocompatibility. PMMA

was chosen for the alignment structure for its machinability and stiffness. Thermocouples

take advantage of the voltage induced when the two materials connected experience a

temperature shift. Thermoelectric devices rely on materials that exhibit the Peltier Effect

and PDMS was chosen for the casing due to its strength, flexibility, manufactuability and

biocompatibility.

• Analytical thermal modeling gave insight into the functionality of thermoelectric devices

while guiding input parameters like the area of the needed heat sink and the appropriate

applied current.

• Finite Element Analysis showed that heat bleeding between modules was negligible and

predicted that even when in contact with skin, the thermoelectric devices would be

capable of keeping the hydrogel cooled to below the LCST.

• Prototype fabrication demonstrated that modules could be controlled individually

• Release rate testing showed that our device could heat the hydrogel enough to induce

medication release. It also demonstrated two types of diffusion. Release of BSA from the

PNIPAM-AAm caused by phase change at LCST and also release of BSA from device

caused by internal concentration gradient. This results in initial burst release, which can

be counteracted by applying shorter initial heating cycles and longer subsequent heating

cycles.

• Analysis, modeling, fabrication and testing has demonstrated proof of concept.

Recommendations for Future Projects

• Further release rate characterization to ensure consistent repeatability and improved

control

• Thermal Management

o Liquid Cooling/ Phase Change Heat Sinks to replace current temporary design

• Removal of Exudates

o Piezoelectric Micropumps, Microchannels, etc to remove bodily fluids released

from wound

• Device Portability

o Battery powered/ FPGA, wires incorporated into PDMS casing

• Custom User Interface for bandage programming

• Additional Drugs Designed for Topical Application

• Exploration of non-topical device applications, possibility of implanting within body

Appendix A: Fabrication Processes

o Hydrogel

o Aluminum Tray

o PMMA Insert

o PDMS Housing

o Test Bed

F.1 - Hydrogel

Drug Loading 1. Dissolve 200 mg of PNIPAM-AAm in M mL of di-ionized water (4% weight

by volume) Note: the shiny pieces will not fully disolve, so remove these

pieces. See Figure 30 and Figure 31.

2. Add 50 mg of Bovine Serum Albumin to the solution (1% weight by volume)

See Figure 32.

3. Stir for 3 days using a magnetic stirring plate

4. Dialize the loaded nanoparticles in 10,000 MWCO (Molecular Weight Cut Off)

tubing in 50 mL of di-ionized water. See Figure 37.

5. Carry out dialisis at 4˚C for 3 hours

6. Collect 3 mL of the dialized water and measure to confirm expected

PNIPAM-AAm concentration

Composite Hydrogel Fabrication 1. Put 800 μL of the drug loaded nanoparticles in a separate dish

2. Add .15g of PEG-DA and mix using the magnetic stirring plate until fully

dissolved. See Figure 33.

3. In a separate dish, combine 100 μL ethanol with 100 μL di-ionized water

4. Add .015g of Irgacure to the ethanol/water solution. See Figure 39.

Note: Irgacure is the photoinitiator so must be protected from light

exposure. Mix water, ethanol and irgacure in a tube that has been

wrapped in aluminum foil. Mix using a Speed Control Mixer.

5. Combine Irgacure and drug loaded solutions. Mix using magnetic stirring plate.

6. Pipette about 68 μL of the solution into the metal device tray.

7. Expose to UV light for about 3 minutes

Note: As heating will make the PNIPAM-AAm release the drugs, be sure to

place the device on an ice pack while exposing it to UV light.

Figure 30 - PNIPA-AAM

Figure 31 - Shiny non-dissolvable PNIPA-AAM film

Figure 347 - 10,000 MWCO Tubing Figure 39 - Irgacure Photo- initiator

Figure 33 - PEG-DA

Figure 32 - Bovine Serum Albumin

Step-in Top Hat

F.2 - Tray

Tray Overview

The portion of the design referred to as the “tray” is responsible for

the containment of the hydro-gel and acts as the interface between the

hydro-gel and the heat source. The tray will be made from surgical grade

stainless steel and will be machined from a solid piece of stock with a CNC

or manual end mill. The basic dimensions for the tray are 8.6mm x 8.6mm

x 3.5mm (length, width, height respectively). Refer to Figure 40 - Pro-E

model of finished tray.

Stock Preparation

1. Begin by selecting a piece of stock which has length and width dimensions

slightly larger than 8.6mm x 8.6mm.

2. Cut the height of your stock to approximately 152mm.

3. The next step is to machine the length and width dimensions to the correct

size. Select a ½” end mill and make passes at 1200 rpm with a linear feed

rate of 0.100 in/sec and a depth of no greater than 0.020in. repeat this

procedure as many times as is necessary to achieve length and width

dimensions of 8.6mm x 8.6mm.

4. Finally use a ban saw and cut the stock into slugs with a height of 6mm.

The final slug should measure 8.6mm x 8.6mm x 6mm.

Outside Surface

1. The first step is to square off the top and bottom of the slug.

2. Orient the slug in the vise so that the 8.6mm length and width

dimensions are in the x and y-axis. Use a ½” end mill at 1200

rpm for the following procedures.

3. Since the top hat section of the tray is not

square the machining process can be broken

into two sections. Each section will consist

of one set of parallel sides.

4. Begin with the first set of parallel sides and

make passes so that the height of the Top

Hat section is 3.0mm and the Step-in

measures 0.9mm. Refer to Figure 41.

5. Next move to the other set of parallel sides and again

machine the height of the Top Hat section to 3.0mm, this

time the Step-in should measure 1.3mm.

Figure 35 - ProEngineer Model of Finished Tray

Figure 36 - Dimension of First Parallel Sides

Inside Surface

1. At this point the outer surface should be machined to size with the

exception of the bottom surface.

2. Remove the tray from the vise and flip it over so that the top hat

portion of the tray is on the bottom, reinsert the tray into the vice so

that the sides measuring 6.8mm are in the x-axis.

3. The next step is to machine the bottom surface (now the top surface)

to its final thickness of 0.5mm.

4. Use a ½”end mill at 1200 rpm with a linear feed rate of 0.100

in/sec. Make passes with a depth of 0.020in until the thickness of

the tray lip is about 0.040in. Reduce the depth of cut to 0.010in

and make passes until the bottom surface of the tray has been machined to

a thickness of 0.5mm (0.020in).

5. The next step is to hollow the inside of the tray. The inside dimensions of

the tray will measure 5.8mm (x-axis) x 5mm (y-axis). Start with an 11/64”

end mill at 1500 rpm and begin removing material in 0.020in increments.

Continue to remove material until the depth of cut is 0.118in (3mm).

6. Replace the 11/64” end mill with a 3/64”. Use this end mill to remove the

material that the 11/64” end mill could not remove.

7. Run the 3/64” end mill at 1700 rpm with a linear feed rate of 0.100 in/sec

and make passes with a depth of cut of 0.010in. Repeat this process until a

depth of 0.118in (3mm) is reached. Refer to Figure 42.

Figure 37 - ProEngineer Model of Finished Tray Bottom View

Figure 38 - Image of Inverted Tray Loaded with Hydrogel

F.3 - PMMA

Step 1 – First, use a band saw to cut a long column of PMMA into a

roughly 10mmx10mmx7mm rectangular prism.

Step 2 – Use a ½ inch diameter end mill to machine

the rectangular prism down to the final desired external dimensions of

8.6mmx8.6mmx5.5mm. The machining is done at

1300 RPM with a feed rate of 10mm/min for this and

all other end mill operations.

Step 3 – Use a 13/64 inch diameter end mill to drill a hole 3.34mm deep

into the center of one of the 8.6mmx8.6mm faces of the block.

Step 4 – Use a 3/64 inch diameter end mill to enlarge the hole into

a 6.8mmx6mm rectangular cavity with rounded corners of 3.34mm

depth. Perform the operation first at a 1.67mm depth and then

again at the 3.34mm depth. The reason for doing it this way is to

prevent the small end mill from being damaged during the

machining process.

Step 5 – Use a 13/64 inch diameter end mill to cut a hole 2.16mm into

the center of the face opposite that which was previously being worked

on. The mill should then be used to machine through a wall parallel to

a 6mm side of the previously milled cavity, staying at a 2.16mm depth.

Step 6 – Use a 13/64 inch diameter end mill to enlarge this hole to a

rectangular cavity with rounded corners which is 8mmx6.6mm at a

depth of 2.16mm. The 8mm dimension is measured from the part

of the wall which has been removed. Like Step 4, this should be

done once at a1.08mm depth and then again at the desired 2.16mm

depth.

Figure 39: Image after Step 1






F.4 - Polydimethylsiloxane (PDMS)

1. Measure out the appropriate volume necessary to generate the PDMS blanket.

2. Mix the PDMS base agent and the curing agent in a 10:1 weight ratio. See Figure 50.

3. Thoroughly stir the solution for about 10 minutes until a thick, uniform texture is reached.

4. Coat the mold in PTFE (polytetrafluoroethylene) spray to lubricate for easy removal of PDMS after it has been cured.

5. Pour the mixed PDMS solution over the mold making sure that there is enough material within each well of the mold. See Figure 51.

6. Place the PDMS mold into a vacuum chamber for about 20 minutes until all of the gas bubbles have been raised to the surface of the solution. See Figure 52.

7. After degassing the solution, place the mold into an oven at approximately 80°C for 2 hours to allow the PDMS to cure. See Figure 53.

8. Remove from oven and let stand until room temperature has been reached.

9. Take care to remove the PDMS from the mold; the PDMS material is flexible but prone to tearing. See Figure 54.

Figure 45 - Weigh Mixture Components

Figure 54 – Completed PDMS Casing

Figure 46 – Aluminum Mold

Figure 52 – Degas Solution in Vacuum Chamber

Figure 47 – Place Mold into Oven

F.5 – Test Bed

Test Bed Overview

The test bed is a key component because it is where we conduct all of our release tests.

The design criteria for this piece of equipment were as follows: Allow us to test a system of three

devices arranged side by side, allow for maximum visibility of the collection reservoir during the

testing procedure and consist of three collection reservoirs of equal volume.

Fabrication 1. We began with a block of Plexiglas and

cut it to approximately 2.5” by 1.25” by

0.75”.

2. Next we brought it to an end mill and

machined out cavities to serve as

collection reservoirs. Cavities measured

approximately 0.8mm by 0.8mm by 10mm

deep.

3. Finally for test bed 2 we glued a magnetic

strip to the top surface.

4. For test bed 3 we glued the PDMS blanket

directly to the top surface.

5. Final assembly of test bed 3 is shown in

Figure 48 – Test Bed 3 Final Assembly.

Figure 48 – Test Bed 3 Final Assembly

Appendix B: Bibliography

Bibliography

American Burn Association. Burn INcidence Fact Sheet. 2005 1-1. 2010 28-11 <http://www.ameriburn.org/resources_factsheet.php>. Mayo Clinic. Burns: First Aid. 2010 5-11. 2010 28-11 <http://www.mayoclinic.com/health/first-aid-burns/FA00022>. Sabnis, Wadajkar, Aswath & Nguyen Factorial Analyses of Photopolymerizable Thermoresponsive Hydrogels for Protein Delivery Sally Abston MD, Patricia Blakeney PhD, Manubhai Desai MD, Patricia Edgar RN, CIC,John P Heggers PhD, David N Herndon MD, Marsha Hildreth RD, Ray J Nichols Jr. MD. Resident Orientation Manual. 2010 1-6. 2010 28-11 <http://totalburncare.com/orientation_intro.htm>. United States Department of Labor. Burn Accidents. 1994 6-5. 2010 <www.bls.gov/spotlight/2010/>. Web M.D. Skin Grafts, Split Thickness. 2010 йил 11-5. 2010 2-12 <http://emedicine.medscape.com/article/876290-overview>.

Appendix C: Dimensioned Drawings

Appendix D: Material Data Sheets

Arctic Silver Incorporated MSDS # AS5_3

Page 1 of 2

SECTION 1: CHEMICAL PRODUCT AND COMPANY INFORMATION Company Address: 9826 W. Legacy Ave. Visalia, CA 93291 Product Information: 559-740-0912 Medical Emergency Toll Free: 877-740-5015 Prepared by: Nevin House Medical Emergency Alternate: 303-739-1110 Revision Date: January 25, 2011

Product Identification

Arctic Silver 5 High-Density Polysynthetic Silver Thermal Compound

Product Code: AS5

SECTION 2: COMPOSITION/INFORMATION ON INGREDIENTS Product Ingredient Information CAS No. Silver (Metallic) 7440-22-4 Boron Nitride 10043-11-5 Zinc Oxide 1314-13-2 Aluminum Oxide 1344-28-1 Ester Oil Blend Non-hazardous SECTION 3: HAZARD IDENTIFICATION

Emergency Overview: Grey grease. This product is nonflammable. Liquid will irritate eyes. Potential Health Effects: Eyes: This product is an eye and mucus membrane irritant. Skin: Not expected to be a skin irritant. Repeated and prolonged skin contact could cause minor skin irritation. Ingestion: Silver ingestion may result in generalized argyria. Inhalation: No specific information available. Pre-Existing Medical Conditions Aggravated by Exposure: eye

SECTION 4: FIRST AID MEASURES Eyes: Immediately flush with large amounts of water. After initial flushing, remove any contact lenses and continue flushing for at least 15 minutes. Have eyes examined by a Physician. Skin: Remove contaminated clothing and wash skin with soap and water. Get medical attention if irritation develops/persists. Wash clothes separately before reuse. Ingestion: If appreciable quantities are swallowed, seek medical advice. Inhalation: Not likely route of exposure. If inhaled and irritation occurs, remove to fresh air. If irritation persists, call a Physician.

SECTION 5: FIRE FIGHTING MEASURES Flash Point: > 600F (Setaflash) LEL/UEL: NA (% by volume in air) Extinguishing Media: Use carbon dioxide or dry chemicals for small fires, aqueous foam or water for large fires involving this material. Fire Fighting Instructions: Remove all ignition sources. Closed containers may rupture due to build-up of pressure when exposed to extreme heat. Fight fire from a safe distance. As in any fire, wear self-contained breathing apparatus (pressure demand, OSHA/NIOSH approved or equivalent) and full protective gear.

SECTION 6: ACCIDENTAL RELEASE MEASURES Large Spills: Remove all sources of ignition (sparks, open flames, etc.). Wear self-contained breathing apparatus and appropriate personal protective equipment. Ventilate area and contain spill with sand or other absorbent material. Collect spill by scooping up liquids and absorbent material and place in a sealed metal container for proper disposal. Do not flush to sewer. Prevent material from entering storm sewers, ditches that lead to waterways and ground. Small Spills: Absorb spill with absorbent material, then place in a sealed metal container for proper disposal.

SECTION 7: HANDLING AND STORAGE Overheating may cause container to rupture. Use explosion proof electrical equipment. Containers must be kept closed and ventilation provided to prevent vapor concentration build-up. Store in a cool dry place. Do not breathe vapor or get liquid in eyes, or on skin and clothing. Keep away from heat or sources of ignition. Check all containers for leaks. Wear protective clothing as in section above. Avoid prolonged breathing of vapors or contact with skin. Ensure that all equipment is grounded to prevent static discharge. Containers of this material may be hazardous when emptied due to solid or vapor residue. All hazard precautions given in this data sheet must be observed for empty containers. KEEP OUT OF REACH OF CHILDREN.

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION Exposure Guidelines: CHEMICAL NAME ACGIH TLV OSHA PEL ACGIH STEL Silver 0.1 mg/m3 0.01mg/m3 NA Boron Nitride 10 mg/m3 10 mg/m3 NA Zinc Oxide 10 mg/m3 (dust) 15 mg/m3 (dust) 10 mg/m3 Aluminum Oxide 10 mg/m3 (dust) 10 mg/m3 (dust) NA Polyol Ester NA NA NA NFPA and HMIS Codes: NFPA HMIS Health 1 1 Flammability 1 1 Reactivity 0 0 Personal Protection - B

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES Physical State: Grey Grease Solubility in Water: <1.0% Odor: None Specific Gravity: 4.05-4.15 pH: NA Evaporation Rate: Slower Vapor Pressure: NA (Butyl acetate=1) (Air 1) Boiling Range: NA Vapor Density: NA (Water =1)

p. 1

1 1 0

He a lt h

Fir e

Re a c t iv it y

P e r s o n a lP r o t e c t io n

1

0

0

B

Material Safety Data SheetAluminum MSDS

Section 1: Chemical Product and Company Identification

Product Name: Aluminum

Catalog Codes: SLA4735, SLA2389, SLA3895, SLA1549,SLA3055, SLA4558, SLA2212, SLA3715

CAS#: 7429-90-5

RTECS: BD0330000

TSCA: TSCA 8(b) inventory: Aluminum

CI#: Not applicable.

Synonym: Aluminum metal pellets; Aluminum metalsheet; Aluminum metal shot; Aluminum metal wire

Chemical Name: Aluminum

Chemical Formula: Al

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Aluminum 7429-90-5 100

Toxicological Data on Ingredients: Aluminum LD50: Not available. LC50: Not available.

Section 3: Hazards Identification

Potential Acute Health Effects:Slightly hazardous in case of skin contact (irritant). Non-irritating to the eyes. Non-hazardous in case of ingestion.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Notavailable. DEVELOPMENTAL TOXICITY: Not available. The substance is toxic to lungs. Repeated or prolonged exposureto the substance can produce target organs damage. Repeated exposure to a highly toxic material may produce generaldeterioration of health by an accumulation in one or many human organs.

Section 4: First Aid Measures

Eye Contact:

http://www.sciencelab.com/

p. 2

Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Get medical attention if irritation occurs.

Skin Contact: Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.

Serious Skin Contact: Not available.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention immediately.

Serious Inhalation: Not available.

Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconsciousperson. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar,tie, belt or waistband.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Non-flammable.

Auto-Ignition Temperature: Not available.

Flash Points: Not available.

Flammable Limits: Not available.

Products of Combustion: Some metallic oxides.

Fire Hazards in Presence of Various Substances: Not available.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product inpresence of static discharge: Not available.

Fire Fighting Media and Instructions:SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray, fog or foam. Do not use water jet.

Special Remarks on Fire Hazards: Not available.

Special Remarks on Explosion Hazards: Not available.

Section 6: Accidental Release Measures

Small Spill:Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water onthe contaminated surface and dispose of according to local and regional authority requirements.

Large Spill:Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on thecontaminated surface and allow to evacuate through the sanitary system.

Section 7: Handling and Storage

Precautions:Do not ingest. Wear suitable protective clothing. If ingested, seek medical advice immediately and show the container or thelabel. Keep away from incompatibles such as oxidizing agents, acids, alkalis.

Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area. Moisture sensitive.

p. 3

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommendedexposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminantsbelow the exposure limit.

Personal Protection: Safety glasses. Lab coat. Gloves.

Personal Protection in Case of a Large Spill: Safety glasses. Lab coat. Gloves.

Exposure Limits:TWA: 5 (mg(Al)/m) from ACGIH (TLV) [United States] Inhalation (pyro powders, welding fumes) TWA: 10 (mg(Al)/m) fromACGIH (TLV) [United States] Inhalation (metal dust) Consult local authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Solid.

Odor: Odorless.

Taste: Not available.

Molecular Weight: 26.98 g/mole

Color: Silver-white

pH (1% soln/water): Not applicable.

Boiling Point: 2327°C (4220.6°F)

Melting Point: 660°C (1220°F)

Critical Temperature: Not available.

Specific Gravity: Density: 2.7 (Water = 1)

Vapor Pressure: Not applicable.

Vapor Density: Not available.

Volatility: Not available.

Odor Threshold: Not available.

Water/Oil Dist. Coeff.: Not available.

Ionicity (in Water): Not available.

Dispersion Properties: Not available.

Solubility:Insoluble in cold water, hot water. Soluble in alkalies, Sulfuric acid, Hydrochloric acid. Insoluble in concentrated Nitric Acid, hotAcetic acid.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Incompatible materials, exposure to moist air or water.

Incompatibility with various substances: Reactive with oxidizing agents, acids, alkalis.

Corrosivity: Not available.

p. 4

Special Remarks on Reactivity:Moisture sensitive. Aluminum reacts vigorously with Sodium Hydroxide. Aluminum is also incompatible with strong oxdizers,acids, chromic anhydride, iodine, carbon disulfide, methyl chloride, and halogenated hydrocarbons, acid chlorides, ammoniumnitrate, ammonium persulfate, antimony, arsenic oxides, barium bromate, barium chlorate, barium iodate, metal salts

Special Remarks on Corrosivity:In moist air, oxide film forms which protects metal from corrosion. Aluminum is strongly electropositive so that it corrodesrapidly in contact with other metals.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Not available.

Toxicity to Animals: Not available

Chronic Effects on Humans: Not available.

Other Toxic Effects on Humans:Slightly hazardous in case of skin contact (irritant). Non-hazardous in case of ingestion. Non-hazardous in case of inhalation.

Special Remarks on Toxicity to Animals: Not available.

Special Remarks on Chronic Effects on Humans: Not available.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: Exposure to aluminum may cause skin irritation. Eyes: Not expected to be a hazardunless aluminum dust particles are present. Exposure to aluminum dust may cause eye irritation by mechanical action.Aluminum particles deposited in the eye are generally innocous. Inhalation: Not expected to be an inhalation hazard unlessit is heatedor if aluminum dust is present It heated or in dust form, it may cause respiratory tract irritation. Heating Aluminumcan release Aluminum Oxide fumes and cause fume metal fever when inhaled. This is a flu-like illness with symptomsof metallic taste, fever, chills, aches, chest tightness, and cough. Ingestion: Acute aluminum toxicity is unlikely. ChronicPotential Health Effects: Skin: Contact dermatitis occurs rarely after aluminum exposure. Most cases of aluminum toxicityin humans are in one of two categories: patients with chronic renal failure, or people exposed to aluminum fumes or dust inthe workplace. The main source of aluminum in people with chronic renal failure was in the high aluminum content of thewater for the dialysate used for dialysis in the 1970's. Even though this problem was recognized and corrected, aluminumtoxicity continues to occur in some individuals with renal who chronically ingest aluminum-containing phosphate bindersor antacids. Inhalation: Chronic exposure to aluminum dust may cause dyspnea, cough, asthma, chronic obstructive lungdisease, pulmonary fibrosis, pneumothorax, pneumoconiosis, encephalopathy, weakness, incoordination and epileptiformseizures and other neurological symptoms similar to that described for chronic ingestion. Hepatic necrosis is also a reportedeffect of exposure to airborne particulates carrying aluminum. Ingestion: Chronic ingestion of aluminum may cause AluminumRelated Bone Disease or aluminum-induced Osteomalacia with fracturing Osteodystrophy, microcytic anemia, weakness,fatigue, visual and auditory hallucinations, memory loss, speech and language impairment (dysarthria, stuttering, stammering,anomia, hypofluency, aphasia and eventually, mutism), epileptic seizures(focal or grand mal), motor disturbance(tremors,myoclonic jerks, ataxia, convulsions, asterixis, motor apraxia, muscle fatigue), and dementia (personality changes, alteredmood, depression, diminished alertness, lethargy, 'clouding of the sensorium', intellectual deterioration, obtundation, coma),and altered EEG.

Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself.

Special Remarks on the Products of Biodegradation: Not available.

p. 5

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: Not a DOT controlled material (United States).

Identification: Not applicable.

Special Provisions for Transport: Not applicable.

Section 15: Other Regulatory Information

Federal and State Regulations:California prop. 65: This product contains the following ingredients for which the State of California has found to cause birthdefects which would require a warning under the statute: No products were found. California prop. 65: This product containsthe following ingredients for which the State of California has found to cause cancer which would require a warning underthe statute: No products were found. Connecticut hazardous material survey.: Aluminum Illinois toxic substances disclosureto employee act: Aluminum Rhode Island RTK hazardous substances: Aluminum Pennsylvania RTK: Aluminum Minnesota:Aluminum Massachusetts RTK: Aluminum New Jersey: Aluminum New Jersey spill list: Aluminum California Director's Listof Hazardous Substances: Aluminum TSCA 8(b) inventory: Aluminum SARA 313 toxic chemical notification and releasereporting: Aluminum

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada): Not controlled under WHMIS (Canada).

DSCL (EEC):

HMIS (U.S.A.):

Health Hazard: 1

Fire Hazard: 0

Reactivity: 0

Personal Protection: B

National Fire Protection Association (U.S.A.):

Health: 1

Flammability: 1

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Not applicable. Safety glasses.

Section 16: Other Information

References:

p. 6

-Hawley, G.G.. The Condensed Chemical Dictionary, 11e ed., New York N.Y., Van Nostrand Reinold, 1987. -Material safetydata sheet emitted by: la Commission de la Santé et de la Sécurité du Travail du Québec. -SAX, N.I. Dangerous Propertiesof Indutrial Materials. Toronto, Van Nostrand Reinold, 6e ed. 1984. -The Sigma-Aldrich Library of Chemical Safety Data,Edition II. -Guide de la loi et du règlement sur le transport des marchandises dangeureuses au canada. Centre de conformitéinternatinal Ltée. 1986. 037 Waste manifest or notification not required.

Other Special Considerations: Not available.

Created: 10/09/2005 03:39 PM

Last Updated: 11/06/2008 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

9025 Technology Dr. • Fishers, IN 46038-2886800-387-0672 • 317-570-7020 • Fax 317-570-7034email:[email protected] • www.bangslabs.com

B E A D SB E A D SB E A D SB E A D SB E A D S A B O V E T H E R E S T

Material Safety Data Sheet

SECTION I - Chemical Product and Company Identification

Date Prepared March 11, 2002

Identity PolymethylMethacrylate (PMMA)

Company Information Bangs Laboratories, Inc. phone:317-570-70209025 Technology Drive fax:317-570-7034Fishers, Indiana 46038

SECTION II - Composition, Information on Ingredients

PolymethylMethacrylate suspended in water or as a dry powder.

SECTION III - Physical/Chemical Characteristics

Boiling Point 100ºC / 212ºF Glass Transition Temp 105ºC

Density 1.19g/cc Solubility in Water Emulsion

Appearance and Odor Brown liquid emulsion.

SECTION IV - Fire and Explosion Hazard Data

Extinguishing MediaWater Fog

Special Firefighting ProceduresN/A

Unusual fire and Explosion HazardsThe dried resin is flammable similar to wood. Burning dry resin emits dense, black smoke.Suspended material is not flammable.

SECTION V - Reactivity Data

IncompatibilitiesMay irreversably aggregate if frozen at 0ºC / 32ºF. Dried resin is combustible. Addition ofchemicals may cause coagulation.

Hazardous Combustion or Decomposition ProductsHazardous decomposition products: methyl methacrylate and carbon monoxide depending oncondition of heating and burning.

SECTION VI - Health Hazard Data

Hazards IdentificationEyes: Mild irritationSkin Contact: Short exposure; no irritation. Repeated prolonged exposure, especially if confined; mild irritation, possibly a mild superficial burn.Skin Absorption: Not likely to be absorbed in toxic amounts. Possibly weak sensitizer.Ingestion: Low single dose toxicity.Inhalation: No guide established. Considered to be low in hazard from inhalation.Systemic and Other Effects: None known.

First Aid MeasuresEyes: Flushing the eye immediately with water for 15 minutes is a good safety practice. Physician should stain for evidence of corneal injury.Skin: Contact may cause slight irritation. Wash off in flowing water or shower. Wash clothing before reuse. Treat as any contact dermatitis. If burn is present, treat as any thermal burn.Ingestion: Low in toxicity. Induce vomiting if large amounts are ingested.Inhalation: Remove to fresh air if effects occur. Consult medical personnel.Systemic: Human effects not established. No specific antidote. Treatment based on sound judgement of physician and the individual reactions of the patient.

SECTION VII - Precautions for Safe Handling and Use

Handling and StorageVentiliation: Good room ventilation usually adequate for most operations.Respiratory protection: None normally needed. In cases where there is a likelihood of inhalation exposure to dried particles, wear a NIOSH approved dust respirator.Storage: Store at temperatures between 4ºC and 8ºC. Material may develop bacteria odor on long term storage. No safety problems known. Do not freeze.

Accidental Release MeasuresAction to take for spills: Flush area with water immediately. Avoid unnecessary exposure andcontact.

SECTION VII - Continued

Disposal ConsiderationsWill color streams and rivers to a milky white. Has practically no biological oxygen demand but willsettle out and form sludge or film. May plug up sanitary sewers. Divert to pond or burn solid wasteiin an adequate incinerator. Flush sewers with large amounts of water.

SECTION VIII - Control Measures

Respiratory ProtectionNone normally needed. In cases where there is a likelihood of inhalation exposure to driedparticles, wear a NIOSH approved dust respirator.

Wash/Hygenic PracticesWash with soap and water when leaving work area and before eating, smoking and using restroomfacilities.

The information herein is given in good faith, but no warranty, expressed or implied, is made.Refer questions or comments to Bangs Laboratories, Inc. (317) 570-7020.

Material Safety Data Sheet PEGDA

Section 1 – Chemical Product and Company Identification

MSDS Name: PEGDA Catalog Numbers: N/A Synonyms: PEGDA Company Identification:

Glycosan BioSystems PO Box 2321 Park City, UT 84060

For information, call: 801-518-6971

Section 2 – Composition, Information on Ingredients

CAS# Chemical Name Percent EINECS/ELINCS26570-48-9 Poly(ethylene Glycol) Diacrylate,

PEGDA Varies unlisted

Hazard Symbols: None listed. Risk Phrases: None listed.

Section 3 – Hazards Identification

EMERGENCY OVERVIEW Appearance: White to Yellow Powder. The toxicological properties of this material have not been fully investigated. Caution! Avoid contact and inhalation. Target Organs: Risk of serious damage to eyes. Known irritant For additional information on toxicity, please refer to Section 11.

Section 4 – First Aid Measures Eyes: Check for contact lenses and remove if present. Flush thoroughly with water while opening eyelids for at least 15 minutes. If symptoms such as redness and irritation persist, obtain medical attention. Skin: Wash material from skin with soap and water and rinse thoroughly with clean water. Obtain medical attention as needed or if irritation develops. Clean contaminated clothing before reuse. Ingestion: May be harmful if swallowed. Only rinse month with water if person is conscious. Obtain Medical attention as needed. Inhalation: Remove person from source to fresh air; if not breathing give artificial respiration. If breathing is difficult, give Oxygen. Notes to Physician: Treat symptomatically and supportively.


Section 5 – Fire Fighting Measures General Information: As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear. Extinguishing Media: Use agent most appropriate to extinguish fire. Suitable: Water spray. Carbon dioxide, dry chemical powder, or appropriate foam. Flash Point: N/A Autoignition Temperature: N/A Flammability: Non-flammable Unusual Fire and Explosion Hazards: As with any organic material, this product may produce toxic carbon monoxide and dioxide fumes if heated to decomposition and airborne dust may present an explosion hazard.

Section 6 – Accidental Release Measures General Information: Exercise appropriate precautions to minimize direct contact with skin or eyes and prevent inhalation of dust. Such as: respirator, chemical safety goggles, rubber boots, and heavy rubber gloves. Spills/Leaks: Wear protective clothing and gloves. Absorb on sand or vermiculite and place in closed container for disposal. Ventilate and wash spill area after material pick-up is complete. Wash contaminated clothing before reuse.

Section 7 – Handling and Storage Handling: User Exposure: Avoid inhalation. Avoid prolonged or repeated exposure. Storage: Keep tightly closed in opaque container. Store away from heat, light, and moisture.

Section 8 – Exposure Controls, Personal Protection Engineering Controls: Safety shower and eye bath. Mechanical exhaust required. Exposure Limits: None listed. OSHA Vacated PELs: None listed for this chemical. Personal Protective Equipment Eyes: Wear appropriate protective eyeglasses or chemical safety goggles. Skin: Wear appropriate protective gloves to prevent skin exposure. Clothing: Wear appropriate protective clothing to prevent skin exposure. Respiratory: Required General Hygiene Measures: Wash thoroughly after handling. Ventilation: Required


Section 9 – Physical and Chemical Properties Physical State: Lyophilized Powder Appearance: White to Yellow Odor: Enzyme Odor pH: N/A Vapor pressure: N/A Vapor density: N/A Evaporation Rate: N/A Viscosity: N/A Boiling Point: N/A Freezing/Melting Point: N/A Decomposition Temperature: N/A Solubility: Immiscible in water Specific Gravity/Density: N/A Molecular Formula: N/A Molecular Weight: N/A N/A = not available

Section 10 – Stability and Reactivity Chemical Stability: Stable Conditions to Avoid: Direct sun light, strong acids, strong bases, elevated temperatures. Incompatibilities with Other Materials: Amines, Strong oxidizing agents, chemically active metals, free radical initiators. Hazardous Decomposition Products: Carbon Monoxide, Carbon Dioxide Hazardous Polymerization: May occur.

Section 11 – Toxicological Information Routes of Exposure Eye: May cause server eye irritation. Skin: May cause skin irritation. Ingestion: May be harmful if swallowed. Inhalation: May be harmful if inhaled. Material may be irritating to mucous membranes and upper respiratory tract. Signs and Symptoms of Exposure The chemical, physical, and toxicological properties have not been fully investigated. Toxicity Data No data available


Section 12 – Ecological Information

No information available

Section 13 – Disposal Considerations

1. Dispose of waste in accordance with all applicable Federal, State and local regulations.

2. Chemical residues are generally classified as special waste and, as such, the transportation, storage, treatment and disposal of this waste material must be conducted in compliance with all applicable Federal, State and local regulations.

3. Rinse empty containers thoroughly before disposal and/or recycling.

Section 14 – Transport Information Non-hazardous for transport.

Section 15 – Regulatory Information General Information For research and development use only. Not for drug, household, or other uses. European/International Regulations Safety Phrases: S: 22 24/25 Do not breathe dust. Avoid contact with skin and eyes. US Label Text US Statement: Caution: Avoid contact and inhalation. United States Regulatory Information

1. Material(s) listed are exempt from the United States Environmental Protection Agency Toxic Substances Control Act (TSCA) inventory when supplied for research and development purposes or used under the Supervision of a technically qualified individual as defined by 40 CFR720.3.

2. The healths risks have not been fully determined. Canada Regulatory Information N/A

Section 16 – Additional Information MSDS Creation Date: 1/1/10 The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall Glycosan BioSystems Inc. be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Glycosan BioSystems Inc has been advised of the possibility of such damages.

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Material Safety Data SheetVersion: 1.10/17/2007

LE-45/TPD/209KG Polydimethylsiloxane Emulsion

Page 1/7

1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

Manufactured By: Momentive Performance Materials 3500 South State Route 2 FRIENDLY WV 26146

Revised: 10/17/2007 Preparer: PRODUCT STEWARDSHIP COMPLIANCE AND STANDARDS CHEMTREC 1-800-424-9300 Chemical Family/Use: Emulsion Formula: Polydimethylsiloxane emulsion HMIS Flammability: 0 Reactivity: 0 Health: 1 NFPA Flammability: 0 Reactivity: 0 Health: 1

2. HAZARDS IDENTIFICATION EMERGENCY OVERVIEW WARNING! Causes eye irritation.

Form: Liquid Color: Opaque white Odor: Mild POTENTIAL HEALTH EFFECTS INGESTION

No evidence of harmful effects from available information. SKIN

May cause minor irritation. May cause the following effects: - itching - slight local redness INHALATION

Short-term harmful health effects are not expected from vapor generated at ambient temperature. EYES

May cause irritation. May cause the following effects: - stinging - excess blinking - tear production - excess redness of the conjunctivae - swelling of the conjunctivae Injury to the cornea is not expected.

MEDICAL CONDITIONS AGGRAVATED

A knowledge of the available toxicology information and of the physical and chemical properties of the material suggests that overexposure is unlikely to aggravate existing medical conditions.

SUBCHRONIC (TARGET ORGAN )

None known.



Page 2/7

CHRONIC EFFECTS / CARCINOGENICITY For additional information, please see Section 11, Toxicological Information.

ROUTES OF EXPOSURE

Eyes

3. COMPOSITION / INFORMATION ON INGREDIENTS PRODUCT COMPOSITION CAS REG NO. WGT. % A. HAZARDOUS Alcohol ethoxylate Trade secret 1 - 5 %

B. NON-HAZARDOUS Water 7732-18-5 60 - 90 % Siloxanes and Silicones, di-me 63148-62-9 30 - 60 %

4. FIRST AID MEASURES INGESTION

Do NOT induce vomiting. If victim is conscious, give 2-4 glasses of water. Never give anything by mouth to an unconscious person. Obtain medical attention.

SKIN

Wash off with soap and water. Get medical attention if symptoms occur. INHALATION

If inhaled, remove to fresh air. If not breathing give artificial respiration using a barrier device. If breathing is difficult give oxygen. Get medical attention.

EYES

In case of contact, immediately flush eyes with plenty of water for at least 15 minutes and get medical attention if irritation persists.

NOTE TO PHYSICIAN

Treatment is symptomatic and supportive.



Page 3/7

5. FIRE-FIGHTING MEASURES FLASH POINT: None (aqueous system) FLAMMABLE LIMITS IN AIR - LOWER (%): Not available FLAMMABLE LIMITS IN AIR - UPPER (%): Not available SENSITIVITY TO MECHANICAL IMPACT: No SENSITIVITY TO STATIC DISCHARGE

Sensitivity to static discharge is not expected. EXTINGUISHING MEDIA

All standard extinguishing agents are suitable. SPECIAL FIRE FIGHTING PROCEDURES

Firefighters must wear NIOSH/MSHA approved positive pressure self-contained breathing apparatus with full face mask and full protective clothing.

6. ACCIDENTAL RELEASE MEASURES ACTION TO BE TAKEN IF MATERIAL IS RELEASED OR SPILLED

Wipe, scrape or soak up in an inert material and put in a container for disposal. Wash walking surfaces with detergent and water to reduce slipping hazard. Wear proper protective equipment as specified in the protective equipment section.

7. HANDLING AND STORAGE PRECAUTIONS TO BE TAKEN IN HANDLING AND STORAGE

Avoid contact with skin and eyes. Keep away from children. Attention: Not for injection into humans. May generate formaldehyde at temperatures greater than 150 C (300 F). See Section 10 of MSDS for details.

STORAGE

Keep container tightly closed. Keep from freezing. FURTHER INFORMATION ON STORAGE CONDITIONS

Recommended storage between 35F (2C) and 80F (26 C).



Page 4/7

8. EXPOSURE CONTROLS / PERSONAL PROTECTION ENGINEERING CONTROLS

Eyewash stations; Showers; Ventilation and other forms of engineering controls are preferred for controlling exposures. Respiratory protection may be needed for non-routine or emergency situations.

RESPIRATORY PROTECTION

May be needed if product is used in a confined or poorly ventilated area. If exposure limits are exceeded or respiratory irritation is experienced, NIOSH/MSHA approved respiratory protection should be worn. Supplied air respirators may be required for non-routine or emergency situations. Respiratory protection must be provided in accordance with OSHA regulations (see 29CFR 1910.134).

PROTECTIVE GLOVES

Impermeable or chemical resistant gloves. EYE AND FACE PROTECTION

Safety glasses OTHER PROTECTIVE EQUIPMENT

Wear suitable protective clothing and eye/face protection. Exposure Guidelines

Component CAS RN Source Value

Absence of values indicates none found PEL - OSHA Permissible Exposure Limit; TLV - ACGIH Threshold Limit Value; TWA - Time Weighted Average OSHA revoked the Final Rule Limits of January 19, 1989 in response to the 11th Circuit Court of Appeals decision (AFL-CIO v. OSHA) effective June 30, 1993. See 29 CFR 1910.1000 (58 FR 35338).

9. PHYSICAL AND CHEMICAL PROPERTIES BOILING POINT - C & F: > 100 °C; > 212 °F; Mixture VAPOR PRESSURE (20 C) (MM HG): < 20.30 VAPOR DENSITY (AIR=1): Heavier than air FREEZING POINT: 0 °C; 32 °F; (approximately) MELTING POINT: 0 °C; 32 °F; (approximately) PHYSICAL STATE: Liquid ODOR: Mild COLOR: Opaque white EVAPORATION RATE (BUTYL ACETATE=1): < 1 DENSITY: 0.9710 g/cm3 VOLATILE ORGANIC CONTENT (VOL): Not determined SOLUBILITY IN WATER (20 C): Dispersible VOC EXCL. H2O & EXEMPTS (G/L): 0



Page 5/7

10. STABILITY AND REACTIVITY STABILITY

Stable. HAZARDOUS POLYMERIZATION

Will not occur. HAZARDOUS THERMAL DECOMPOSITION / COMBUSTION PRODUCTS

After evaporation of water, residue can burn to produce:; Oxides of carbon.; Oxides of silicon.; Formaldehyde.; Carbon monoxide is highly toxic if inhaled; carbon dioxide in sufficient concentrations can act as an asphyxiant.; Acute overexposure to the products of combustion may result in irritation of the respiratory tract.; This product contains methylpolysiloxanes which can generate formaldehyde at approximately 300 degrees Fahrenheit (150'C) and above, in atmospheres which contain oxygen. Formaldehyde is a skin and respiratory sensitizer, eye and throat irritant, acute toxicant, and potential cancer hazard. A MSDS for formaldehyde is available from Momentive.

INCOMPATIBILITY (MATERIALS TO AVOID)

None currently known. CONDITIONS TO AVOID

None known.

11. TOXICOLOGICAL INFORMATION OTHER EFFECTS OF OVEREXPOSURE

No adverse effects anticipated from available information.

12. ECOLOGICAL INFORMATION ECOTOXICOLOGY

All available ecological data have been taken into account for the development of the hazard and precautionary information contained in this Safety Data Sheet.

13. DISPOSAL CONSIDERATIONS DISPOSAL METHOD

Disposal should be made in accordance with federal, state and local regulations.

14. TRANSPORT INFORMATION



Page 6/7

Further Information: This product is not regarded as dangerous goods according to the national and international regulations on the transport of dangerous goods.

15. REGULATORY INFORMATION Inventories

Korea Existing Chemicals Inventory (KECI)

y (Positive listing)

Japan Inventory of Existing & New Chemical Substances (ENCS)


EU list of existing chemical substances


Australia Inventory of Chemical Substances (AICS)


Philippines Inventory of Chemicals and Chemical Substances (PICCS)


TSCA list y (Positive listing) China Inventory of Existing Chemical Substances


Canada DSL Inventory y (Positive listing) Canada NDSL Inventory n (Negative listing) For inventories that are marked as quantity restricted or special cases, please contact Momentive. US Regulatory Information SARA (311,312) HAZARD CLASS

Acute Health Hazard SARA (313) CHEMICALS

Canadian Regulatory Information Other SCHDLE B/HTSUS: 3910.00.0000 Silicones in primary forms CALIFORNIA PROPOSITION 65

This product does not contain any chemicals known to State of California to cause cancer, birth, or any other reproductive defects.



Page 7/7

16. OTHER INFORMATION OTHER

These data are offered in good faith as typical values and not as product specifications. No warranty, either expressed or implied, is made. The recommended industrial hygiene and safe handling procedures are believed to be generally applicable. However, each user should review these recommendations in the specific context of the intended use and determine whether they are appropriate., C = ceiling limit NEGL = negligible EST = estimated NF = none found NA = not applicable UNKN = unknown NE = none established REC = recommended ND = none determined V = recommended by vendor SKN = skin TS = trade secret R = recommended MST = mist NT = not tested STEL = short term exposure limit ppm = parts per million ppb = parts per billion By-product= reaction by-product, TSCA inventory status not required under 40 CFR part 720.30(h-2).

Technical Data Sheet

HYSOL® US1750™September-2007

PRODUCT DESCRIPTIONHYSOL® US1750™ provides the following productcharacteristics:Technology UrethaneAppearance (Part A) ClearAppearance (Part B) ClearAppearance (cured) ClearComponents Two component - requires mixingMix Ratio, by volume -Part A: Part B

1 : 1

Mix Ratio, by weight -Part A: Part B

50.5 : 49.5

Cure Room temperature cureApplication Potting and Encapsulating

HYSOL® US1750™ elastomeric polyurethane, is a water-white, clear, medical grade, fast gel potting material. It is idealfor blood heat exchanger, dialyzer and oxygenerator units.

TYPICAL PROPERTIES OF UNCURED MATERIALPart A Properties

Density, @ 25 °C, g/cm³ 1.08Viscosity, Brookfield - RVF, 25 °C, cP:Spindle , speed r/min 350

Part B PropertiesDensity, @ 25 °C, g/cm³ 1.06Viscosity, Brookfield - RVF, 25 °C, cP:Spindle , speed r/min 370

Mixed PropertiesGel Time, 100 gm mass @ 45 °C, minutes 5 to 7Drystick Gel 25 gm mass, @ 25 ºC, minutes 60 to 70Viscosity, Brookfield - RVF, 25 °C, cP:

Spindle , speed r/min 510

TYPICAL CURING PERFORMANCERecommended Curing Conditions

16 hours @ 25 °C (Recommended cure)1 hour @ 50 °C (Alternate cure)

TYPICAL PROPERTIES OF CURED MATERIALPhysical Properties:

Shore Hardness , Durometer A 78Density, @ 25 °C, g/cm³ 1.07Tensile Strength, psi 541Tensile Elongation, % 198Glass Transition Temperature, °C 30Coefficient of Linear Thermal Expansion, ppm/ºC:Alpha 1, @ -20 to 0 °C 137Alpha 2, @ 60 to 80 °C 235Thermal Conductivity, W/mk 0.19

Electrical Properties:Dielectric Strength, 20 mils thickness, volts/mil 1,292Surface Resistivity, ohms @ 25ºC 5.66×1013

Volume Resistivity, ohm/cm @ 25ºC 1.06×1013

Dielectric Constant / Dissipation Factor @ 25ºC:100-Hz 6.41 / 0.0721-kHz 5.99 / 0.067100-kHz 5.01 / 0.056

GENERAL INFORMATIONFor safe handling information on this product, consult theMaterial Safety Data Sheet, (MSDS).

Not for product specificationsThe technical data contained herein are intended as referenceonly. Please contact your local quality department forassistance and recommendations on specifications for thisproduct.

Note: Before using this product please purge approximately 30ml. of material prior to application. Discard purged material inaccordance with the Material Safety Data Sheet. A videoinstruction is available upon request.

StorageStore product in the unopened container in a dry location. Storage information may be indicated on the product containerlabeling.Liquid Storage - Liquids should be stored at 23°C orbelow, in closed containers. If stored below 23°C, thematerial MUST be allowed to come to room temperature, inthe sealed container, to avoid moisture contamination.Material removed from containers may be contaminated duringuse. Do not return product to the original container. HenkelCorporation cannot assume responsibility for product whichhas been contaminated or stored under conditions other thanthose previously indicated. If additional information is required,please contact your local Technical Service Center orCustomer Service Representative.

Conversions(°C x 1.8) + 32 = °FkV/mm x 25.4 = V/milmm / 25.4 = inchesN x 0.225 = lbN/mm x 5.71 = lb/inN/mm² x 145 = psiMPa x 145 = psiN·m x 8.851 = lb·inN·m x 0.738 = lb·ftN·mm x 0.142 = oz·inmPa·s = cP

NoteThe data contained herein are furnished for information onlyand are believed to be reliable. We cannot assumeresponsibility for the results obtained by others over whose

TDS HYSOL® US1750™, September-2007

methods we have no control. It is the user's responsibility todetermine suitability for the user's purpose of any productionmethods mentioned herein and to adopt such precautions asmay be advisable for the protection of property and of personsagainst any hazards that may be involved in the handling anduse thereof. In light of the foregoing, Henkel Corporationspecifically disclaims all warranties expressed or implied,including warranties of merchantability or fitness for aparticular purpose, arising from sale or use of HenkelCorporation’s products. Henkel Corporation specificallydisclaims any liability for consequential or incidentaldamages of any kind, including lost profits. The discussionherein of various processes or compositions is not to beinterpreted as representation that they are free fromdomination of patents owned by others or as a license underany Henkel Corporation patents that may cover suchprocesses or compositions. We recommend that eachprospective user test his proposed application before repetitiveuse, using this data as a guide. This product may be coveredby one or more United States or foreign patents or patentapplications.

Trademark usageExcept as otherwise noted, all trademarks in this documentare trademarks of Henkel Corporation in the U.S. andelsewhere. ® denotes a trademark registered in the U.S.Patent and Trademark Office.

Reference 1.1

Americas+626.968.6511

Europe+49.89.320800.1800

Asia+86.21.2891.8863

For the most direct access to local sales and technical support visit: www.loctite.com

Arctic Silver Incorporated MSDS # AS5_3

Page 2 of 2

(Air = 1) Percent Volatile: < 0.2%

SECTION 10: STABILITY AND REACTIVITY INFORMATION Stability: This product is stable. Conditions to Avoid: Contamination with incompatible materials. Incompatibility: Avoid strong oxidizing agents, strong acids and alkalis. Products of Decomposition: Carbon monoxide, carbon dioxide, silicon dioxide, oxides of nitrogen, and incompletely burned hydrocarbons which may include minute traces of formaldehyde. Reacts with acids and alkalis to form combustible hydrogen gas. Hazardous Polymerization: May not occur. Conditions to avoid: NA

SECTION 11: CARCINOGEN INFORMATION Cancer Information: No ingredients listed as human carcinogens by NTP or IARC

SECTION 12: ECOLOGICAL INFORMATION Environmental Impact Information Avoid runoff into storm sewers and ditches that lead to waterways. Water runoff can cause environmental damage. REPORTING US regulations require reporting spills of this material that could reach any surface waters. The toll free number for the US Coast Guard National Response Center is: 1-800-424-8802

SECTION 13: DISPOSAL CONSIDERATIONS Dispose of in accordance with all federal, state and local regulations. Water runoff can cause environmental damage.

SECTION 14: TRANSPORTATION INFORMATION Air and Ground Shipments: Not Regulated

SECTION 15: REGULATORY INFORMATION SECTION 313 SUPPLIER NOTIFICATION This product contains the following toxic chemicals subject to the reporting requirements of Section 313 of the Emergency Planning and Community Right-To- Know Act of 1986 (40 CFR 372). Product contains no Section 313 listed chemicals. This information should be included on all MSDSs copied and distributed for this material. TOXIC SUBSTANCES CONTROL ACT (TSCA). All ingredients of this product are listed on the TSCA Inventory.

SECTION 16: OTHER INFORMATION Do not puncture or incinerate containers. Normal ventilation for standard manufacturing practices is usually adequate. Local exhaust should be used when large amounts are released. WHMIS: Ingredient disclosure list: None Status: Noncontrolled

To the best of our knowledge, the information contained herein is accurate. However, all materials may present unknown hazards and should be used with caution. In particular, improper use of our products and their inappropriate combination with other products and substances may produce harmful results which cannot be anticipated. Final determination of the suitability of any material is the sole responsibility of the user. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that may exist.

controlled release drug delivery system - asm international

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