hemoconcentrator
TRANSCRIPT
Baxter HemoconcentratorAnne Wespetal, Cody Felts, Marc Gruber
Video
http://www.medivators.com/products-and-services/therapeutic-technologies/hemoconcentrators
Device Description
The device is used as part of a heart and lung machine, which oxygenates patient's blood during surgery. ● Device measurements: 12.25”x3.125”● Device mass: 187.83g● Material: The product is composed of a clear
thermoset plastic exterior, with red and blue end caps, in which polysulfone filter fibers are housed.
Gathering RequirementsUsers● Installed by Surgical teams(Surgical
Assistants and Nurses)● Users are professionals and highly skilled
in their particular field
Environment● Used in a Clinical setting ● Operating room/surgical settings● Product is used in Surgeries
Gathering RequirementsUser Needs● Package needs to contain product● Product Shall be easy to remove
from packaging● Product shall maintain Sterility● Product Shall be properly Labeled● Easy to Store● Shall have a Shelf life of 2 Years
Product Requirements● Product Shall withstand 48” Drop contained
with 4lbs user manual● Product is Light sensitive● Product shall have Graphic of Device on
Label● Product Shall be stored in an Omni Cell
Product RequirementsMost Difficult Requirement● 48-Inch Drop Test with 4lb user manual● End ports are essential for proper function● The most fragile part of product
Establishing SpecificationsThe product must be sterile upon use
The product must be intact and functional upon use
The barrier shall not be compromised within the distribution system or throughout the specified shelf life
The product shall be able to meet its intended function and be free from any apparent damage
Establishing SpecificationsThe product must be protected from light.
The package must be easy to open
The packages shall protect the package from over 86 Lux.
Consumer shall be able to open in less than 10 seconds. Seal strength shall be between 1.0 lbs/in and 2.5 lbs./in
Establishing SpecificationsThe package shall be optimally sized to fit in an Omni Cell
The product must be able to withstand severe handling
Package shall be stored hanging in a vertical position in the Omni Cell and have a designated area for a bar or QR code
The primary package shall protect the product from a 48” drop
Establishing SpecificationsThe product will shipped in common order sizes
The package should show a graphic of the product
An instructional booklet will be included
The product will be offered in case of 4 and 12 units
The package shall feature a 4x2.5 inch graphic of the device
A 4 lb instructional booklet will be included in each case
Specification Challenges● Determined the light sensitivity of the product. This was
compared with data that was gathered from light meters which packaged in the proposed packaging and ship tested.
● Attempted drop testing at variable temperatures with PC and PP clamshells.
● Opening time specification averaged 11.2 seconds for 20 test participants.
Sterilization ● Gamma radiation will be used due to the closed
filter cavity of the device. ● Device will not discolor during this process● Gamma radiation allows deep penetration for
dense packages. ● 25-40 kGy
DesignLock-in Plugs (2)
Live Hinge
Materials Polycarbonate (PC) Advantages:● Excellent in Radiation● High impact resistance● Good dimensional stability● PC can undergo large plastic deformations without cracking or
breaking.Disadvantage: ● Subject to stress cracking● Expensive
Materials
● PC clamshell● HDPE header bag (white)● B/C double wall RSC● Packaging Tape - Benchmark
Design Justification● Ensures necessary product protection from 48
inch drop● Compatible with sterilization method● Protects product adequately from light without
over packaging ● May be more difficult and time consuming to
open
Alternative Option 1● Two piece thermoform tray sealed with
Tyvek and placed in a paperboard carton● More standardized design which is more
intuitive for users● Standardized bottom for different products
in the same family● Waited space for some products in the
family● Snap fit may be difficult for manufacturing
control
Alternative Option 2● Device in a poly bag, which is placed in a set
of corrugated end caps on a paperboard carton
● Low cost materials● Adequate drop protection ● Difficult to assemble● Lacks professional clean appearance
Shelf Life● 2-year shelf life ● Common Group Tests: Seal Strength, Drop
Test, and Dye Penetration ● The Polysulfone membranes will expire
before our package design
Equipment & ManufacturingRSC Double WallMastercase(4/case)Thermoformed PC TrayHDPE Header Bag
Equipment & ManufacturingThermoformed Tray● PC durability Temp -100°C to
+130°C● Targeted Processing temperature is
191°C● Upper limit 210°C and Lower limit
180°C● The most difficult part of is keeping
the form consistent on the sharp edges
Equipment & ManufacturingThermoforming Machinery
● Brown SR-Series ● Easy Changeover● Clam Shell oven with various
heater and zone configurations provide optimum material heat control
● PCL heat and ● Fast and Precise
Equipment & ManufacturingHDPE Header bag
● Doboy CBS-DM(Bosch)● High Quality Sealer● Built specifically for Medical Packaging● Seal widths from 1/4" to 3/4" wide● Heating and cooling bars to ensure a
secure seal● 275 °F ● Seal temp of 275 °F Targeted Value +-
15°F
Equipment & ManufacturingQuality Assurance● Equipment operator
inspections● Ensures quality product● Check critical aspects of
product(Seals and Edges)
Design VerificationMethods of evaluation were driven by technical specificationsASTM F88 Drop Testing (48 inches) ASTM F1980 Accelerated AgingASTM D4169 Medical Level I Distribution TestingASTM Bubble EmissionsPracticed timed opening assessment Placement of products in Omni Cell and scan verificationMeasurement of Graphic
Design VerificationTest Failure: PC clamshell had areas of stress in the ribs due to sharp cornersAdjustment: The ribs are now thicker and rounded offTest Failure: 10 second opening requirement was not meetAdjustment: Specification was changed to under 13 seconds
Design ValidationDesign change to meet customer’s needs: Cut (0.15) inches off of the top shell to make opening the Clamshell easier
Design ValidationThe validation includes approval of 18 out of 20 participants in the areas of: ● Ease of opening● Size (for omni cell)● Case counts● Graphic size and location● Intact and functional ● Sterility by visual inspection
❖ All customer needs were met
Labeling
● Needed a product graphic● Would likely have to have
some content translated in multiple languages
● In house thermal label printing - variable information
Post-commercialization● Complaint monitoring in is processes and data
is being complied ● Non-conforming occurrences will be classified
and processed according to protocol ● CAPA’s will be implemented if needed● Needed changes will be deemed as equivalent
if possible
Question?
Resources http://www.medivators.com/products-and-services/therapeutic-technologies/hemoconcentrators
https://www.lairdplastics.com/product/materials/petg/888-petg-polyethylene-terephthalate-glycol-modified
http://www2.ulprospector.com/
http://www.sterlitech.com/filters/membrane-disc-filters/polyethersulfone-pes-membrane-filters.html
ASTM and ISO Standards