nsf/ansi 49 nsf/ansi 49 - 22010 010 - mabsa mabsa presentation 2011-09.pdf · bsc installations....

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UpdatesUpdates

NSF/ANSI 49 NSF/ANSI 49 -- 20102010

Copyright © 2011 Micro-Clean, Inc.

All Rights ReservedCopyright © NSF 2010

Micro-Clean, Inc. does not represent, endorse, or

recommend any BSC or filtration device

manufacturer, or type of device over another. Any

pictures, materials or descriptions presented here are

for educational purposes only.

DisclaimerDisclaimer

2

• Understand the latest NSF/ANSI Std 49

changes on how they impact current

BSC installations.

– Many older BSCs may not meet the current expectations of NSF

– Customers should routinely evaluate their safety and equipment processes as part of safety committees with key departments represented

ObjectivesObjectives

• have HEPA/ULPA filtered downflow air that is a portion of

the mixed downflow and inflow air from a common plenum (i.e., a plenum from which a portion of the air is exhausted from the cabinet and the remainder supplied to the work

area);

• may exhaust HEPA/ULPA filtered air back into the laboratory

or to the environment through an external exhaust system

connected to the cabinet with a canopy connection; and

• Type A1 cabinets are not suitable for work with volatile toxic chemicals and tracer amount of volatile radionuclides

BSC Types A1 / A2BSC Types A1 / A2

3

• have HEPA/ULPA filtered downflow air composed

largely of uncontaminated recirculated inflow air;

• exhaust most of the contaminated downflow air to an

external exhaust system through a dedicated duct

connected to cabinet with a direct connection and

exhausted to the atmosphere after passing through a

HEPA/ULPA filter; and

BSC Type B1BSC Type B1

• have HEPA/ULPA filtered downflow air drawn from the

laboratory or the outside air (i.e., downflow air is not recirculated from the cabinet exhaust air);

• exhaust all inflow and downflow air to the atmosphere

through an external exhaust system connected to cabinet

with a direct connection after filtration through a

HEPA/ULPA filter without recirculation in the cabinet or return to the laboratory; and

BSC Type B2BSC Type B2

4

• Canopy connection

• Direct connection

Other new definitionsOther new definitions

• Canopy connection – required for

externally vented A1 or A2 BSC (5.2)

• Direct connection – required for

externally vented B1 or B2 BSC (5.3)

Exhaust requirementsExhaust requirements

5

• All biologically contaminated ducts and

plenums in Types A1, A2, B1, and A2

cabinets shall be maintained under

negative pressure or enclosed within a

negative pressure zone. (5.4)

– B2 directly exhausted (nonrecirculated) negative pressure zone was dropped

Duct and Plenum designDuct and Plenum design

• Any Type A1 or A2 cabinet when

canopy connected shall have an audible

and visual alarm to indicate notifying the

user of a potential loss in canopy

containment (5.23.4)

A1 / A2 Exhaust AlarmsA1 / A2 Exhaust Alarms

6

Updated drawingsUpdated drawings

Copyright © NSF 2010

• Conforms to requirements of UL 61010-1

Resistance to overturningResistance to overturning

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• The cabinet shall be tested by a National Recognized Testing Laboratory (NRTL) for compliance to the requirements of the current edition of any national standard that is based on IEC 61010-1. Compliance is demonstrated by cabinet listing, i.e. UL, CSA, or IECEE CB Scheme certificate.

Electrical SafetyElectrical Safety

• The manufacturer shall determine the aerosol

introduction point that provides the most uniform distribution (reference IEST-RP-CC-03422). The

location of the aerosol introduction point shall be

clearly described or indicated in a manner readily

available to the certifier. The location should be

described either on the cabinet data plate or with the

electrical schematic if the schematic is affixed to the

cabinet. (NSF 49 - 2009, A.2.3.1)

Annex A Annex A -- Filter Leak TestFilter Leak Test

8

• “BSC Selection, Installation, Life Span and

Decommissioning” section was moved from

Annex G (Decontamination) to Annex E,

now this title renames Annex E with this

new information.

– Formerly “Recommendations for Installation”

Annex G parts to Annex EAnnex G parts to Annex E

• E.1.Biosafety Consultation Prior to BSC Purchase

• Risk Assessment Procedure

• Selection of a BSC cabinet

• Prior to the Purchase [“Location” section from old Annex E

ended up in here]

• Inspection

• Moving a Permanently Installed Biosafety Cabinet

• Lifespan of BSCs

• E.8. Decommissioning process

Moved from Annex G to EMoved from Annex G to E

9

• Risk Management

Assessment Table was

reworked

• Biosafety Cabinet Selection

• Configuration drawings

added

E.2.8 Risk E.2.8 Risk

AssessmentAssessment


• What needs to be protected?

• What are all of the different types of work to be done in the cabinet?

• What types and quantities of chemical vapors will be

generated in the BSC?

• If the unit requires an exhaust system, is there an appropriate location for the cabinet and its ductwork?

• NEW QUESTION: If the volume of air moved by the BSC

exhaust system is reduced, or eliminated, due to a

malfunction, what is its effect on BSC performance, and

what is preferred by the user?

Deciding class and type now Deciding class and type now

determined by a new 5determined by a new 5thth questionquestion

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• Question #4• E.3.1.4 (formerly) G.3.1.5. If the unit requires an exhaust

system, is there an appropriate location for the cabinet and its ductwork?

• 2nd para: When connected to a hard-ducted exhaust system, however,

the location of the cabinet becomes dependent on the location of the

exhaust system. The exhaust duct must be placed so it can penetrate

ceilings and floors without disturbing other ventilation or plumbing

systems. The exhaust system must also be designed to minimize

excessive lengths and elbows. The exhaust system configurations of

Type A and Type B BSCs are shown in figures E3 and E6,

respectively. Hard ducting Type A cabinets is not acceptable and

shall only be exhausted through a properly designed and fitted

exhaust canopy.

“Not acceptable” hard ducted A’s “Not acceptable” hard ducted A’s

• Work area outlet are limited in their

amperage rating due to other components

on the same power cord, blowers, lights, etc.

• Recommendation to add an external voltage

regulator when wall outlet line voltage

variations affect cabinet airflows.

E.3.3.2 Electrical OutletsE.3.3.2 Electrical Outlets

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• Have a maximum height specified by

manufacturer to prevent BSC overturning;

this maximum should never be exceeded.

E.3.3.5. Base StandsE.3.3.5. Base Stands

• “Proper cabinet operation should be

confirmed by airflow smoke pattern at each

site of use. If a cabinet is relocated to

another facility, or subjected to excessive

shock and/or vibration during moving, the

BSC should be recertified to ensure it

is functioning in a proper manner.”

E.3.3.6 Mobile InstallationsE.3.3.6 Mobile Installations

NuAire

12

• E.4.2.1 Location of BSC– The cabinet should be located away from traffic patterns, doors, fans,

ventilation registers, fume hoods, and any other air-handling device that

could disrupt its airflow patterns.

• E.4.2.2 Clearances (NSF 2008 numbers in parentheses)– BSCs not connected to an exhaust system should have at least 6” (3”)

clearance from any overhead obstruction when the cabinet is in its final

operating position, to allow for testing of the Exhaust HEPA/ULPA filter.

– (NSF 2008 required 12” above if using TA for airflow on exhaust HEPA. This is no longer mentioned. MCI submitted change request to NSF)

– Maintain 6” (12”, 3” absolute minimum) clearance on sides, 12” (12”, 1.5”

absolute minimum) clearance behind unit, for service.

E.4. the former “Location” E.4. the former “Location”

section in Annex E section in Annex E

• It is recognized that there is interest in utilizing the increasingly sophisticated modulated flow exhaust ventilation systems where the exhaust from Type B1 or B2 cabinets, CFH, flexible exhaust hoses, and/or room exhausts are

modulated based on use to optimize containment, maintain appropriate pressure differentials, and maximize energy savings by reducing overall exhaust volume. These systems are required to maintain a high level of control of many complex factors over a number of years. Although the potential cost savings are great, the severity of the hazards contained by the

biological safety cabinets requires the use of simpler and more reliable constant flow systems for the cabinet exhaust.

• If a modulated flow exhaust system is used, it is recommended that the operation of the cabinet exhaust be verified under a variety of conditions over time. Furthermore, the type of exhaust alarm must be assessed in the light of

the type of sensors and controls used in the modulated flow system.

[2010 dropped] modulated [2010 dropped] modulated

flow exhaust systemflow exhaust system

13

• Exhaust System Performance – canopy connected Type A1 and A2 BSC F.7.3.3

– Using a visual medium source positioned to

demonstrate containment of BSC exhaust by the

canopy, reduce the external exhaust until the

alarm signals audibly. The alarm shall sound before visible canopy containment is lost. Direct connected Type A1 or A2 BSC shall not be considered in compliance with the standard.

Annex FAnnex F

• All new cabinets shall conform to the requirements of the current edition of any national standard that is based on IEC 61010-1. Cabinets initially qualified under versions of NSF/ANSI 49 prior to 2009 edition shall conform to UL 61010A-1 or may refer to NSF 49 – 1992 for Electrical leakage, ground circuit resistance, and polarity tests if necessary.

F.8F.8 Electrical leakage & ground Electrical leakage & ground

circuit resistance & polarity testscircuit resistance & polarity tests

14

• Annex K, “Protocol for the validation of

alternative biosafety cabinet decontaminating

methods and agents” was added to provide

guidance for anyone attempting to validate a

space decontamination gas other than

formaldehyde or chlorine dioxide.

New Annex KNew Annex K

QuestionsQuestions

15

Biological Safety Cabinet Biological Safety Cabinet Use, Maintenance and Use, Maintenance and

OperationOperation

NuAire

Germfree Laboratories

Baker Company

LabConCo Corporation

Thermo Scientific

ESCO

• Review new changes to NSF 49 that impact how BSCs

are used, installed, or require modification to stay current with today’s safety and health expectations.

• Understanding maintenance and operations of BSCs.

• “Don’ts” within a BSC

• BSC troubleshooting & problem diagnosis

• New technology and life expectancy of BSCs


16

• Committee Process Review– Primary Investigator / Production Manager

– Industrial Hygienist / Safety

– Laboratory Ventilation Management Program overview / Chemical Hygiene Program

• BSC Type Selection based by use / hazards

• Venting from laboratory

• Recirculation

• Hazards– Biohazards

– Chemicals – volatility

– Radioisotopes

– Hazardous Drugs or Powders

– Prions

BSC SelectionBSC Selection

Class II Type A1 BSCClass II Type A1 BSC

• Offers product, personnel & environmental protection.

• 75fpm minimum intake velocity

• Downflow and Exhaust HEPA

filtered air from a common

positive pressure plenum

• A1s built after 2008, common plenums must be surrounded

by negative pressure

• No volatile toxic chemicals or radionuclides allowed

• Exhaust HEPA filtered air to

room or out of building via

canopy exhaust connection

Intake

Exhaust

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Class II Type A2 BSCClass II Type A2 BSC• Same as Class II Type A1, plus


• All common plenums

surrounded by negative

pressure

• Allows minute quantities of

volatile toxic chemicals or tracer

amounts of radionuclides only when vented through a properly functioning canopy exhaust connection

Intake

Exhaust

Canopy

Connection

Class II Type B1 BSCClass II Type B1 BSC• Product, personnel & environmental

protection


• Downflow air composed largely of

uncontaminated recirculated inflow

air

• Exhaust contaminated downflow air

to facility external exhaust system

after passing through a

HEPA/ULPA filter.

• Allows minute quantities of volatile

toxic chemicals or tracer amounts

of radionuclides when used in

direct exhaust portion or when not

interferes with recirculation of

downflow air

Intake

Exhaust

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Class II Type B2 BSCClass II Type B2 BSC• “Total Exhaust”, no recirculation

• Product, personnel and

environmental protection.

• Supply air from room or ducted


• Exhaust all downflow and inflow

air after passing thru a HEPA/

ULPA filter then outside building

via hard-connection facility exhaust system

• Use volatile toxic chemicals and radionuclides required as an adjunct to microbiological studies.

Exhaust

Supply

Intake

• Industry standards

are updated over

time as studies

and research

reveal critical

improvements and

need for change to

enhance the

safety of BSC use.

Industry UpdatesIndustry Updates


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• Two significant changes to the NSF 49

standard have ended the grace period from

making voluntary upgrades of BSC

installations to now-mandatory compliance

to be considered as an NSF-listed device

– A1/A2 exhaust configuration

– Ducted cabinets must have exhaust duct alarms

Voluntary to MandatoryVoluntary to Mandatory

Exhaust requirementsExhaust requirements


All Rights Reserved

Canopy connection – required for externally vented A1 or A2 BSC

Hard ducting Type A cabinets is NOT ACCEPTABLE and shall only be exhausted

through a properly designed and fitted exhaust canopy.

Direct connection – required for externally vented B1 or B2 BSC

CDC and NIH

CDC and NIH

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• Any Type A1 or A2 cabinet when canopy

connected shall have an audible and visual

alarm to indicate notifying the user of a

potential loss in canopy containment.

• Type B1 and B2 BSC must be ducted to

operate so must already have an exhaust

alarm

A1 / A2 Exhaust AlarmsA1 / A2 Exhaust Alarms


All Rights Reserved

• Part 1 - Read the Manufacturer’s O & M Manual

• Part 2 - Plan workflow procedure– Safety

– Sterility

– Cross-contamination

• Part 3 - Develop BSC Cleaning & Maintenance schedule

• Part 4 - Ergonomics

• Part 5 - What not to do in a BSC

• Part 6 – Diagnosing problems

Getting StartedGetting Started

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• How the BSC works

• Turn-on / Turn-off procedures

• Component descriptions

• Recommended cleaning/maintenance

• Alarm indications

• Troubleshooting

– Most modern BSC manuals are available on manufacturers’ websites

Part 1 Part 1 -- Read the Read the

Manufacturer’s O & M ManualManufacturer’s O & M Manual

• Not all BSCs come pre-labeled by their manufacturer.

• 29 CFR part 1910.145 “Specifications for accident prevention

signs and tags”

BSC Hazard LabelingBSC Hazard Labeling

29 CFR 1910.145(f)(8)(i)

“Biological hazard tags shall be used

to identify the actual or potential

presence of a biological hazard and to

identify equipment, containers, rooms,

experimental animals, or combinations

thereof, that contain or are

contaminated with hazardous

biological agents.”

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• Rudimentary Controls– Blower

– Lights

– Outlets

• Technology breeds sophistication– Airflow automation

– Sash controls

– Remote controls

– Exhaust system controls

Simple or Sophisticated ControlsSimple or Sophisticated Controls

ThermoFisher

Scientific

ThermoFisher

Scientific

• Alarms are for YOUR

SAFETY

• Never disable the audible

alarm

• If alarm persists, seek

maintenance or

certifier help

Alarm IndicationsAlarm Indications

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• Know the safe work area in BSC

• Minimize room activity

• Avoid BSC air curtain disruptions

• Utilize aseptic technique

• Use unidirectional air to your advantage

• Safe removal of components from BSC

Part 2 Part 2 -- Plan workflow procedurePlan workflow procedure

Safe work area in BSCSafe work area in BSC

Rear of BSC

Safe Work Zone Area

Front intake grille (non-safe)

Armrest

Airfoil

Front of BSC

Sash

Top view of BSC

S

I

D

E

W

A

L

L

S

I

D

E

W

A

L

L

24

• BSC placement should not be affected by – Door motion

– Room supply vents

– Air Conditioners / windows

– Equipment exhaust fans

• Unnecessary personnel movements create disruptive air currents near inflow opening

• Person walking past BSC – Creates draft up to 175 FPM

– May disrupt inflow (100-110 FPM)• Loss of containment

• Compromised sterility

Minimize room activityMinimize room activity

• Minimize hand / arm exit from sash opening

• No quick moves, especially from intake

• Minimum number of items to perform task

• Do not overload work surface

• Do not use open flame or burners unless

absolutely necessary and approved

Avoid air curtain disruptionsAvoid air curtain disruptions

25

• Avoid contact transmission of contaminants

• Touch contact of contaminated surfaces is

leading cause of non-sterile product or

transfer of contaminants outside BSC

• Final wipe down (sterility) of BSC should be

done in single directions

• Sterile wipe down of components into BSC

• Use “First Air”

Utilize aseptic techniqueUtilize aseptic technique

• Keep sterile product upstream of

contaminants

• Sweeping action of air

• Keep contaminated,

discarded items to rear

Use unidirectional air to your Use unidirectional air to your

advantageadvantage

First

Air

Side View

HEPA Filter

Contaminant

s

26

Rear of BSC

Safe Work Zone Area


Armrest

Airfoil

Front of BSC

Sash

Top view of BSC

S

I

D

E

W

A

L

L

S

I

D

E

W

A

L

L

• Turn-off UV lamp

• Set sash height to manufacturer’s value

• Turn-on blower and fluorescent light

• Allow cabinet to purge for minimum 5 minutes

• Wash arms and hands

• Don PPE appropriate for tasks

StartStart--upup

27

• Perform “Daily” scheduled cleaning

CleaningCleaning

BakerSG-400

SL-12345VSept 2011

10

• Apply absorbent matting (if needed)

• Do not obstruct front, side or rear grills

• Load and clean materials

• After loading is complete, wait 2-3

minutes to purge contaminants

• Start your work

Loading material & EquipmentLoading material & Equipment

28

Courtesy: CDC/NIH Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets, 3rd edition

Clean to Dirty layoutClean to Dirty layout

• Upon work completion, allow BSC to run 2-3

minutes to purge airborne contaminants

• Surface decontaminate any equipment that

came in contact with contaminated material

• Cover / cap all trays and containers before

removing from the BSC

Final PurgingFinal Purging

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• Surface wipe down the interior surfaces of the cabinet with 70% IPA, or suitable disinfectant

– Disinfectants containing Chlorides and Halogens may

damage stainless steel

– Limit contact times

– These disinfectants are followed by a final wipe of 70%

IPA or non-corrosive, anti-microbial agent

• All surfaces to air dry

• Remove PPE and wash hands / arms

Cabinet DisinfectionCabinet Disinfection

• Turn-off BSC lights and blower*

• Close sash

– Use UV light, if preferred

• *NOTE: Certain BSC types or configurations

require 24-hour operation. “What not to do”

ShutShut--downdown

30

• Daily

• Weekly

• Monthly / Quarterly

• Annually / Biannually

• Schedules can be adjusted based on trended cleaning and operating results

Part 3 Part 3 -- Develop BSC Cleaning & Develop BSC Cleaning &

Maintenance scheduleMaintenance scheduleMonth / Year __________ / ______ Mon Tues Wed Thurs Fri

Daily

Blower/Lights/Outlets ON/UV OFF TC KBF TC TC TC

Exhaust Alarm GREEN/Enabled TC KBF TC TC TC

Prep Aseptic Cleaning TC KBF TC TC TC

Set Sash height to ___ inches TC KBF TC TC TC

Pressure Gauge Reading 0.65 0.66 0.65 0.66 0.66

Post-work Cleaning TC KBF TC TC TC

Weekly

Inspect backwall paper catch

Clean external sash glass

UV Bulb cleaning

Quarterly - Mar-Jun-Sep-Dec

Interior / Exterior cleaning

Gas Valve soap bubble test

Annual - DECEMBER

Replace UV bulb

Biannual - DEC - Even years

Replace Fluorescent Bulbs

Comments:

• Document gage readings – trend results

• Work surface cleaning– 70% IPA

– Suitable disinfectant

– Refer to Mnfr. O&M

manual for recommended

cleaning agents

– CETA CAG-004-2007– http://www.cetainternational.org/

reference/CAG0042007i.pdf

Daily ScheduleDaily Schedule

Starve Load

+

31

• Disinfect the inside surfaces of the cabinet

• Inspect pre-filters under / behind work surface

• Clean side walls, back wall, intake and rear grills

• Sash glass – use glass cleaner – both sides

• UV light cleaning– Lint-free cloth dampened with alcohol or ammonia water

• CAUTION: Do NOT spray airflow sensors, diffuser or HEPA filter. Do not touch HEPA filter– Results in permanent damage to HEPA - leaks,

contamination

– Spraying airflow sensor affects its electrical resistance –compromises inflow/downflow accuracy and your safety

WeeklyWeekly

• Using disinfectants– Clean underside of work surface

– Drain trough – drain valve installed

• Inspect and clean rear paper catch

• Inspect all service valves for proper operation

• Clean BSC exterior – front, sides and top with damp cloth – dust removal

• CAUTION: Do not touch or spray Exhaust HEPA filter. Do not remove or touch exhaust guards, screens, plates or damper settings

• Perform weekly cleaning

Monthly / QuarterlyMonthly / Quarterly

32

• Replace UV lamp, if equipped– Effective life is ~ 7000 hours

• Annual certification (sooner if critical or regulatory requirements)

• All monthly / quarterly activities

AnnuallyAnnually

BiannuallyBiannually

• Replace the fluorescent lamp(s)

• Creates a safer, efficient, healthful, more

comfortable work environment

– Posture

– Body, hand, arm, leg positioning

– Work habits

Part 4 Part 4 -- ErgonomicsErgonomics

33

• Feet solidly comfortably on floor / footrest

– Don’t dangle feet / compress thighs

• Vary leg positions throughout day

– Avoid concentrated pressure points along the underside of your thigh near the knee and the backside of your lower leg

• Get up and walk around at least every hour

Feet, knees & legsFeet, knees & legs

• Chair should fully support your body

• Distribute your weight

• Use the entire seat and backrest

– Don’t slouch

• Shared chairs – don’t assume the chair

is set for you – adjust as necessary

Your backYour back

34

• Keep forearms, wrists and hands in a

straight, natural position

– Don’t anchor your wrists

– Don’t rest your palms on the work surface while working

Forearms, wrists and handsForearms, wrists and hands

• Adjust chair or BSC height so your

shoulders are relaxed

• Elbows should hang comfortably at your

sides

• Relax – muscles that build tension such

as shoulders

Shoulders and elbowsShoulders and elbows

35

• Take breaks– Short, frequent breaks are more beneficial than

fewer, longer breaks

• Vary your tasks– Break up your routine

• Reduce sources of stress– Physical

– Psychological

• Breath fresh air deeply and regularly– BSC intense work may tend to lead to breath-holding

or shallow breathing

Work habitsWork habits

• …use a BSC without a valid certification

label attached

Part 5 Part 5 –– What not to do in a BSC What not to do in a BSC

Do not

SPECIALISTS IN CLEAN AIR CERTIFICATIONP.O. BOX 21806

LEHIGH VALLEY, PA 18002-1806

1-800-523-9852

Date Tested: _________________________________________ August 3, 2010

Test Report No.:

Date Due Retest:

Tested By James T. Technician

_____________________________

Other _____________________________

_____________________________

0810-0301-500F

August 2011

James T. Technician

36

• … overload the work surface area

• … block front, side, or rear grills

• … obstruct any part of the front intake

opening

Don’tDon’t

Rear of BSC

Safe Work Zone Area


Armrest

Airfoil

Front of BSC

Sash

Top view of BSC

S

I

D

E

W

A

L

L

S

I

D

E

W

A

L

L

• Alcohol bottle in intake

• Mat on intake grille

• Container blocking

back wall

• Sash height?

• Drain valve missing

• Current certification

label missing

• No Biohazard Warning

Label on front of BSC

What’s wrong with this picture??

37

• … change or disable the exhaust low flow

exhaust alarms

• … use a BSC

while in alarm

Don’tDon’t

• … place items on top of the BSC

blocking or damaging the exhaust filter

Don’tDon’t

supplies

38

• … turn off the supply blower or close

the sash to hard-ducted BSCs

• May damage the sash, if closed.

• Causes premature loading of exhaust HEPA

filter

and / or

• Non-updated A1 / A2 cabinets may develop

contamination issues from reverse airflow

through clean side of the supply HEPA filter

• Exceptions:

– Roof exhaust can be turned off at the BSC location

– Roof blower is interlocked to the supply blower

Don’tDon’t

• … operate the UV light while working in

the hood or when people are occupying

the lab

Don’tDon’t

39

Troubleshooting Troubleshooting

Unidirectional Unidirectional

Flow Devices & Flow Devices &

BSCsBSCs

ThermoFisher Scientific

NuAire

Germfree Laboratories Baker Company

LabConCo Corporation

Pressure GaugesPressure Gauges• Monitors plenum

pressure (+) or motor suction (-)

– Positive 0-2” range

– Neg 0-0.25”,0.5 or 1”

40

Negative

PositiveGermfree Laboratories

Velocity vs. Pressure Velocity vs. Pressure

RelationshipRelationship

• High pressure – low velocity =

loaded HEPA

• Low pressure – low velocity =

restricted or starved of air

– Positive pressure gauges

(1 - 2” W.C.) responds

as above. Starve Load

41

Negative Pressure GaugesNegative Pressure Gauges

• Negative (0.25” - <1.0” W.C. gauge size) reads blower suction or negative plenum pressures

• Opposite of Positive Pressure Gauge

• Filter loading will give

lower pressure readings

• Starved HEPAs show

higher pressure

BSC Most Common FailuresBSC Most Common Failures

• Motor/Blower failures– Worn bearings (age)

– AC Motor Cooling Vent restrictions – overheat, thermal overload

– Thermal overload – high current thru motor trips safety circuit breaker inside motor (motor shuts down to cool off, starts up on own once cooled)

– Motors are most-likely to thermally overload after a HEPA filter change (lesser pressure load)

– AC Motors are most-efficient when under load (dirty HEPA filter) – AC current drops

• Speed control failures

42

Work Surface VibrationWork Surface Vibration

• Foreign material in blower impeller

– Throws balanced blower wheel out of balance, like car tire weights – vibrates if unbalanced

– Remove foreign material

• Unbalanced impeller

– Replace impeller

• That’s where that missing pipette wrapper

went!!

Grainger

Grainger

Scraping noiseScraping noise

• Blower impeller rubbing against

blower housing– Loosen, center, or tighten impeller

setscrew

– If impeller is out-of-round – replace

43

Fluttering NoiseFluttering Noise• Foreign material in impeller

• Foreign material in filter plenum– Remove foreign material

• Foreign material in back wall, under

work surface– Remove foreign material

• Loose or torn blower boot or plenum bag– Reattach or replace blower boot or bag

• Simple BSCs have blower &

lights on same circuit breaker

• Outlets on separate breaker

• Energy efficiency in forefront

• Current production BSCs

– microprocessors, membrane touch panels, solid-state relays, display screens, energy efficient ballasts and lamps

– DC or 3-phase AC blower motors for improved energy efficiency

– Sophistication breeds complications, problems, increased upfront and replacement parts cost

Electrical ProblemsElectrical Problems

44

• First modern BSCs were developed in 1960s

• Motor used at the time was Permanent Split

Capacitor (PSC) motor controlled by simple Triac

speed control that “chopped” unneeded voltage

• Not very efficient

• Heat waste byproduct

Permanent Split Capacitor MotorsPermanent Split Capacitor Motors

Excerpt from CETA Performance Review – April 2009

• 3-phase Induction Motor

• Brushless DC motor

• Hybrid AC circuits controlling DC motors

– All produce less heat, less damage to

associated wiring

– Other advantages

Energy Efficient AlternativesEnergy Efficient Alternatives

Excerpt from CETA Performance Review – April 2009 Excerpt from CETA Performance Review – April 2009

Excerpt from CETA Performance Review – April 2009

45

• Three Manufacturers: “A”, “B”, & “C”

• Four foot 10” sash A2 operating amperage (A) between

last revision of PSC motor to newest Energy Efficient

motor

• All information from Mfr O&M manuals

PSC motor Energy Efficiency

“A” 6.6 A 4.0-6.0 A

“B” 9 A 2.9 A

“C” 13.5 FLA 8 FLAFLA – Full Load Amperage

Energy Use ComparisonsEnergy Use Comparisons

• Reduced heating issues to motors / wiring will reduce

failures from heat-related issues

• Fewer thermal overloads, equipment shutdown

• Less BTUs generated by BSCs – less cooling

needed for labs

• One BSC manufacturer has gone as far as extending its repair warranty from 36 to 60 months for BSCs equipped with energy-saving motors

• One manufacturer is offering retrofits from older AC

PSC motors to DC motors

Unseen advantagesUnseen advantages

46

NuAire PTB0186 NU-425 DC ECM motor upgrade info Rev2.pdf

NuAire PTB0186 NU-425 DC ECM motor upgrade info Rev2.pdf

47

• “With sophistication comes cost”

• Most motors must be “taught” or

programmed as to what type cabinet

they are to be installed

• Most motors must be ordered from

manufacturers who must program

• Delays in getting failed BSCs back into

service

DisadvantagesDisadvantages

• Most BSCs have a life expectancy of 15 years

• Manufacturers may stop supporting older BSCs

– Typically do support common parts, if parts are available from

suppliers

• Common OEM components may no longer be available from suppliers to BSC Manufacturers

– AC Permanent Split Capacitor Motors

– Speed Controls

– Wiring harnesses

– Switches

– Light Ballasts for Fluorescent and UV lamps

– Light bulbs – Fluorescent T12 bases

Older BSCsOlder BSCs

Component unavailability may result from actions of the U.S. government and international groups

48

Technology UpdateTechnology Update• Many T12 fluorescent bulbs are inefficient, being phased out

• In September 2000, the U.S. Department of Energy (DOE) published

the Fluorescent Lamp Ballast Energy Conservation Standards (10 CFR,

Part 430), which established new minimum ballast efficacy factor

(BEF) standards

• Energy Policy of Act of 2005 (EP Act 2005) extend the coverage of BEF

standards, which will result in the phased elimination and sale of most

magnetic ballasts in new fixtures, including those designed to operate

34W T12 lamps, starting in 2009, and replacement ballasts in 2010.

Action 2005 BEF Standards for Full-Wattage T12 Lamps

2009 BEF Standards for Energy-Saving T12 Lamps

Ballast manufacturers can no longer make ballasts that do

not pass the new requirements for use in new fixtures. April 1, 2005 July 1, 2009 Ballast manufacturers cannot sell ballasts that do not pass

the new requirements to U.S. fixture manufacturers. July 1, 2005 October 1, 2009 Fixture manufacturers cannot sell fixtures that include

ballasts that do not pass the new requirements. April 1, 2006 July 1, 2010

Department of Energy will prohibit the manufacture of T12 magnetic ballasts solely for replacement purposes.

July 1, 2010 July 1, 2010

QuestionsQuestions

49

Decontamination Decontamination –– Alternative Alternative

TechniquesTechniques


• Discuss general steps in performing a

BSC decontamination

• Chemical-Specific Issues

– Methodologies

– Advantages / Disadvantages

• Comparison

50

Why Decontaminate?Why Decontaminate?

• BSC’s protect personnel and environment from hazards or protects product

• If one needs to work on equipment that has been exposed to biological viables, decontamination is required to protect the technician and the surrounding space

• If a BSC is to be used for cultivating viables for a new program, need to protect from viables of prior work

Typical ApplicationsTypical Applications

• Maintenance or other need to access

contaminated plenums

• Moving of BSC

• HEPA filter replacement

• Clean-up of a contamination event

• End or change of work program

51

Requirements for aRequirements for a

Successful DeconSuccessful Decon• Disinfection – typically looking for a

log 4-6 kill of test bacterial spores

• Choice of disinfectant

• Penetration to all surfaces

• Penetration through HEPA filter and into “dead legs”

• Temperature and humidity control

• Containment of fumigant

Requirements for a Requirements for a

Successful Decon (cont’d.)Successful Decon (cont’d.)

• Disposal of disinfectant

– Vent, neutralize, scrub

• Validation of disinfection

– Biological indicators

• Material compatibility

• Safety

52

General Preparation OptionsGeneral Preparation Options

• Seal BSC when decontamination required

• Construct BSC with decontamination facilities included

• Permanently modify BSC for specific decon type

• Ensure gas-tight damper if ducted to building

• Insert recirculation (optional)

General Preparation General Preparation ––

Biological IndicatorsBiological Indicators

• Given 7-day test time, typically assume decontamination method already validated

• If using indicators, often B. atrophaeus or G. stearothermophilus

• Use appropriate substrate (not cellulose for HP)

• Upstream and/or downstream of HEPA filters

• Log-Kill enumeration versus Go / No Go

• Controls

53

General Preparation General Preparation –– FinalFinal

• Establish and measure proper humidity

and temperature

• Final seal

• Pressure check (neutral to adjacent area)

• Establish safety perimeter

• Meet OSHA requirements

General ProcedureGeneral Procedure

• Fumigant generation to a steady state concentration

• Environmental monitoring for leakage

– e.g., Draeger pumps, infrared analyzers

• Appropriate personnel protective equipment (PPE)

– Full face respirator, gloves, lab coat

• Neutralization or scrubbing � Ventilation

54

General Procedure (Cont’d.)General Procedure (Cont’d.)

• Validation of BSC Decontamination

– Biological Indicators (opt.)

– Monitoring of relative humidity, space temperature, and/or decontaminant concentration during process

Choice of DecontaminantsChoice of Decontaminants

• Formaldehyde Gas

• Hydrogen Peroxide Vapor

• Chlorine Dioxide Gas – MCI preferred

55

Formaldehyde Gas (CHFormaldehyde Gas (CH22O)O)

• Typically via depolymerization of Paraformaldehyde (PF)

• NSF standard 0.3 gm/ft3 � ~8000 ppm

• Mechanism: methylization of DNA

• Requires relative humidity > 60%

• Target contact time > 6 hr

• Use Bacillus atrophaeus as B.I.

Formaldehyde Gas (Cont’d.)Formaldehyde Gas (Cont’d.)

• Neutralization with ammonia gas (NH3)– Decomposition of ammonium carbonate (at 1.0-

1.1 times PF weight)

– Or ammonium bicarbonate (at 1.6 time PF weight)

– ~ 1 hour contact time

• Vent and environmental monitoring

• Clean “fall-out”– Mixture of methenamine and PF

– Can limit PF polymerization with humidity control

56

Formaldehyde GasFormaldehyde Gas

Formaldehyde Gas Formaldehyde Gas ––

AdvantagesAdvantages

• “True” gas

• Relatively inexpensive

• General material compatibility

• Industry accepted

• Validated

57

Formaldehyde Gas Formaldehyde Gas –– IssuesIssues

• “Fall-out” residue

– Added clean-up time

• Carcinogen

• Potential residual odor

• Polymerization on cold surfaces

Formaldehyde Operating Formaldehyde Operating

ConditionsConditions

• Cabinet preparation – 30-60 min

• Gas generation – 15-30 min

• Contact time – 6-12 hours

• Neutralization and venting – 60-90 min

• Clean-up 30-60 min

Total – 9-15 hours

58

Hydrogen Peroxide Vapor (HHydrogen Peroxide Vapor (H22OO22))

• Typically delivered by flash vaporization of aqueous peroxide mixture– The mixture is generally close to or above

saturation in air

• Two major vendors of generators with significant differences

• Mechanism: oxidation

• Requires contact time less than formaldehyde

• Use Geobacillus stearothermophilus as B.I.

HP Vapor HP Vapor –– STERIS (VHP)STERIS (VHP)

• Avoids condensation on surfaces to minimize corrosion and optimize distribution

• Typically two portals into BSC for VHP inlet and return

• Design cabinet with appropriate circulation paths

• Dehumidify to < 30% relative humidity

– In order to avoid condensation of VHP

– VHP generation introduces humidity

59

HP Vapor HP Vapor –– STERIS (cont’d.)STERIS (cont’d.)

• Typical 1-2 mg/liter, 750-1500 ppm(D ~ 1-2 min)

– D Value – amount of time to achieve 1-log

reduction

• Target 70-85% RH during decontamination

• Continually introduce HP, decomposing HP in return

• Cycle Phases: Dehumidification / Conditioning / Decontamination / Aeration

HP Vapor HP Vapor –– BIOQUELL BIOQUELL

((ClarusClarus))

• Seeks “micro-condensation”

– BQ believes D ~ 2 min requires liquid presence

• Swiveling source to inject high-speed

droplets to all surfaces

– Condensate “bounces”

• Monitor for onset of condensation

60

HP Vapor AdvantagesHP Vapor Advantages

• Safe by-products (water and oxygen)

• No residue

• Industry accepted

• Automated

• Relatively short cycle time if properly

engineered

HP Vapor IssuesHP Vapor Issues

• Instability of HP toward decomposition– Flow pattern is critical to “beat”

decomposition rate

• Decomposition may block access of decontaminant

• Condensation may cause control issues– Heat-tracing or pre-thermal treatment

• Capital equipment cost

61

HP Vapor Issues (cont’d.)HP Vapor Issues (cont’d.)

• Cellulose materials absorb or decompose– May effect decontamination or aeration

• Some material issues – nylon, cellulose, copper, lead, iron oxide, epoxy– Condensation may effect painted surfaces

• Potential reaction to materials used in testing cleanrooms / BSCs or filter components– Titanium tetrachloride or TiO2 may act as a catalyst

on filter surfaces – from Steris

– Glycol on surfaces may oxidize when in HP contact – from Bioquell

SetSet--Up Example of VHP 1000Up Example of VHP 1000

62

HP Operating ConditionsHP Operating Conditions(based upon limited information)(based upon limited information)

• Set-up / Tear-down:30-60 min

(depends if cabinet is reconfigured)

• Typical duration from conditioning through decontamination:

2-4 hours

• Typical aeration:2-4 hours

Total – 5 - 9 hrs

Chlorine Dioxide Gas (ClOChlorine Dioxide Gas (ClO22))

• Mechanism: Oxidation (no chlorination)

• Generated on site via reaction:

– Cl2(g) + 2NaClO2 � 2ClO2(g) + 2NaCl

• Visible yellow-green gas

• Humidification required, 65-90% RH

• 1700 ppm concentrationMCS system – DRS Laboratories

63


Chlorine Dioxide Gas (Cont’d.)Chlorine Dioxide Gas (Cont’d.)

• Scrubbing– Wet, with alkaline solutions

– Dry, via adsorption (e.g., charcoal)

• Direct venting option (use by paper industry)

• Monitor concentration and relative humidity

• Use Bacillus atrophaeus as B.I.

• DRS Laboratories – Halide Group, ClorDiSys Solutions, Sabre

Oxidation Technologies (different reaction)

64

Chlorine Dioxide Gas Chlorine Dioxide Gas ––


• Safe by-products (oxygen and salt)

• No residue

• Not flammable / explosive

• “True gas” – no condensation issues

• Reputation for use in Anthrax

decontamination

Chlorine Dioxide Chlorine Dioxide -- IssuesIssues

• Less well-known or characterized

• Mild corrosion/discoloring to cold steel, copper, brass,– Particularly in the presence of water

• Potentially corrosive if chlorine gas (Cl2) is present– Care to avoid Cl2 in synthesized CD

– Care to avoid Cl2 creation by UV exposure

• Low PEL limit (0.1 ppm)

65

CD Operating ConditionsCD Operating Conditions

• Set-up / Tear-down:60 - 90 min

• Typical duration from humidification through decontamination:

60 - 90 min

• Typical aeration:15 - 30 min

Total: 3 - 4 hr

NSF/ANSI 49 NSF/ANSI 49 –– 2008 Annex G2008 Annex G

“Prior to decontamination with an alternative method [note added: other than depolymerized paraformaldehyde or chlorine dioxide gas] (such as vaporous hydrogen peroxide [VHP]), cycle parameters and validation of those parameters must be developed for each model and size of BSC.”

Recommended decontamination methods

66

Issue Formaldehyde

Gas

Hydrogen Peroxide

Vapor

Chlorine Dioxide

Gas

Sporocidal effectiveness + + +

Effective through HEPA filters+ + / ? +

Non Carcinogenic - + +

Toxicity (TWA PEL) 0.75 ppm 1.0 ppm 0.1 ppm

Humidity requirement (RH)60-90%

30% (VHP) or ambient

(Clarus)65-90%

No residue - + +

+ (VHP) / + /

? (Clarus) - (with chlorine)

Method of removal Neutralizer Catalytic breakdown Scrubbing

Limited development effort + - +

Limited cost + - - / +

Cycle Time (hr) 9 to 15 4 to 7 3 to 4

Non-corrosive +

ComparisonComparison

References (partial)References (partial)• Formaldehyde

– Kruse, R. H et al. (1991). Biological Safety Cabinetry. Clinical Microbiology Reviews, 4, 207-241.

– The National Sanitation Foundation (2002). Annex G – Recommended microbiological decontamination procedure, National Sanitation Foundation: Standard No. 49 for Class II (Laminar Flow) Biohazard Cabinetry, G1-G3.

– Taylor, L.A. et al. (1969). Paraformaldehyde for Surface Sterilization and Detoxification. Applied Microbiology, 17, 614-618.

– Fink, R. et al. (1988). Biological safety cabinets, decontamination or sterilization with paraformaldehyde. Am. Ind. Hyg. Assoc. J., 49, 277-279.

• Hydrogen Peroxide

– Hillman, D. (2004). Vapor phase hydrogen peroxide gas decontamination of a BSC. Performance Review, 10, 10-16.

– Watling, D. et al. (2002). Theoretical analysis of the condensation of hydrogen peroxide gas and water vapour as used in surface decontamination. PDA J. Pharma Sci Technol., 56, 291-299.

– Jones, R. et al. (1994-5). ACUMEN, 1, No. 1-4, Baker Company.

67

References (Partial)References (Partial)

• Chlorine Dioxide– Luftman, H., Regits, M., Lorcheim P., Lorcheim K., & Paznek D. (2008)

“Validation Study for the Use of Chlorine Dioxide Gas as a Decontaminant for Biological Safety Cabinets” Applied Biosafety: Journal of the American Biological Safety Association, 13(4), 199-212.

– Luftman, H. S., & Regits, M. A. (2008). B. Atrophaeus and G. Stearothermophilus biological indicators for chlorine dioxide gas decontamination. Applied Biosafety: Journal of the American Biological Safety Association, 13(3), 143-157.

– Luftman, H. S., Regits, M. A., Lorcheim, P., Czarneski, M. A., Boyle, T., Aceto, H., et al. (2006). Chlorine dioxide gas decontamination of large animal hospital intensive and neonatal care units. Applied Biosafety: Journal of the American Biological Safety Association, 11(3), 144-154.

– Jeng, D.K. and Woodworth, A.G. (1990). Chlorine dioxide gas sterilization under square-wave conditions. Appl. Environ. Microbiol., 56, 514-519.

– Leo, F.P. et al. (2005). Design, development and qualification of a microbiological challenge facility to assess the effectiveness of BFS aseptic processing. PDA J. Pharm. Sci. Technol., 59, 33-48.

QuestionsQuestions

68

Economic Alternatives for Economic Alternatives for Laboratory ContainmentLaboratory Containment

• Discuss the advantages and

disadvantages of alternatives to

conventional laboratory containment

devices

– Ductless fume hoods

– Balance enclosures


69

• Containment devices that may utilize

HEPA/ULPA filters or an assortment of

chemi-sorbent filtration systems to

contain process contaminants.

Ductless Fume HoodsDuctless Fume Hoods

Captair ErlabLabconco Corp AirClean Systems

• AFNOR NF X 15-211 “Enclosures for

Toxics with Recirculating Air Filtration”

• ASHRAE 110 – 1995 “Method of

Testing Performance of Laboratory

Fume Hoods”

• SEFA 9 – 2010 “Recommended

Practices for Ductless Enclosures”

Industry Factory TestingIndustry Factory Testing

70

• Offers simple containment devices

without costly venting out of laboratory

• Saves energy costs

• Space saver

• Ideal for low hazard experimentation

• No ductwork contamination


• Ductless fume hoods are not

recommended for use with unknown

chemicals or reactions.

• Limited to manufacturer-approved

applications

• Requires strict adherence to chemical

hygiene program

• Abuse can be catastrophic

DisadvantagesDisadvantages

71

• Thorough risk assessment and hazard

determinations should be investigated

before selecting use of this type of

device, and any other device.

– Are all ductless fume hoods alike?

– Can they be used safely?

– What materials may I use in a DFH?

Safety ConcernsSafety Concerns

• NFPA 45 "Standard on Fire Protection for

Laboratories Using Chemicals" 2010 Edition, Annex A (Explanatory Material), paragraph A.8.4.1

• "Ductless chemical fume hoods that pass air from the hood interior through an absorption filter and then discharge the air into the laboratory are only applicable for use with nuisance vapors and dusts that do not present a fire or toxicity hazard."

National Fire Protection National Fire Protection

AssociationAssociation

72

• No !!!

– Uses

• liquid, powder, combinations of both

– Types of filtrations

• HEPA, carbon filter, proprietary blends

– Layers of filtration

• Single, double (safety filter), HEPA-carbon combo

– Protection mechanisms from chemical breakthrough

• How will the user know if the filter reaches saturation?

Are all DFHs alike?Are all DFHs alike?

• Single or double layer of filtration

– Safety filter usually has detection port or mechanism for breakthrough

– Only allows failure of 1st stage

Filtration LayersFiltration Layers

PrimaryPrimary

Safety

73

• Electronic chemical detection sensors

• Chemical reactive tubes

• Banana oil (Isoamyl Acetate)

• Nose

Warning mechanismsWarning mechanisms

PrimaryPrimary

Safety

• Detection sensors and chemical

reactive tubes can quantify the

amount of breakthrough

Warning mechanismsWarning mechanisms

Drager

95 fpm

0.00 ppm

Labconco Corp.

74

• Most DFH manufacturers offer

application specialists or chemical use

survey form to determine the best

option for your expected use.

• Ultimately, the decisions will be up to

the end user and their safety committee

ConsultationsConsultations

• Same advantages as DFH plus:

– Set airflow specific to your application

• 60 to 100 fpm ideal for containment while not

disrupting balance operation

• Won’t scatter lightweight powders during weighing operations

– May be used for higher toxicity powders when precautions are taken

– More options available

Lab Balance EnclosuresLab Balance Enclosures

75

• Material hazards

– Powders

– Volatility (option to duct out of facility)

• Canopy exhaust connection recommended

• Plan on how to handle filter replacement

– BIBO capability

• Spot filtration or distant filtration

– Contamination to ductwork

ConsiderationsConsiderations

• Numerous configurations based on need and

location

• Laboratory weighing to bulk powder

applications

Labconco Corp.Baker Co.

Flow Sciences

76

QuestionsQuestions

ASHRAE 110 UpdatesASHRAE 110 Updates

77

Objectives Objectives

• Discuss general procedure and future

changes of the ASHRAE 110

performance test that yields quantitative

data about laboratory chemical hood

containment in a more accurate

method, with repeatable results.

Chemical Hood Test MethodsChemical Hood Test Methods

• Face Velocity Testing

– Cheapest, but least accurate.

• ASHRAE 110 Testing

– More expensive, but produces better results.

– Takes into account such things as turbulence.

• Personal Air Sampling

– Very expensive and time consuming, but is the most accurate.

78

ASHRAE SAFETYASHRAE SAFETY

• Why is ASHRAE 110 testing so important?

– Normal face velocity

and smoke tests do

nothing to show

containment when someone is standing at the hood opening (as a mannequin would be).

– Airflow patterns can vary significantly.

SEFA vs. SEFA vs. ASHRAE 110ASHRAE 110

• Advantages of ASHRAE 110– Safety

• Tests more of the laboratory chemical hoods containment capabilities

– More tests• Large Volume Smoke Study

– Challenge hood with smoke from a smoke generator

• Tracer gas test

– Four different types of tracer gas tests

79

SEFA vs. ASHRAE 110 TestsSEFA vs. ASHRAE 110 TestsSEFA ASHRAE 110

X Room Ventilation Test

X X Face Velocity Test

X X Alarm Verification

X X Local Volume Visualization Test

X Large Volume Visualization Test

X Tracer Gas Containment Test

�Positional Control Test

�Leakage Test

�Sash Movement Effect Test

�Walk-by Test

Room Ventilation TestRoom Ventilation Test

• Check baffle configuration

– should be 3/4” open at top

• Pass smoke source 4-6” outside hood opening

• Record all disruptions of normal airflow and corrective actions taken

80

Face Velocity ProfileFace Velocity Profile

• Set sash to designed height

• Measure opening to determine access area

• Form grid starting 6” in on all sides

– Grid not to exceed 1 sq. ft.

• Record avg. velocity and calculate volume

• Velocities must be monitored for 5 seconds in each position

• Sampling time and data averaging

• … anemometer shall be used to take and record twenty velocity readings, taken at the rate of one per second, at the center of each grid rectangle. Calculate the average of the twenty readings…”

Upcoming changesUpcoming changes

81

VAV Response TestVAV Response Test• At 50% open, anemometer

is placed in the ringstandand sash is closed to approximately 25%

• Stopwatch for response

• Return to 50%, raise the sash to the full open (or 100%) position

• Record the time it takes for the velocities to return to within 10% of the initial 50% value

• Anemometer probe placement change

– either placed in the exhaust ductwork or

– hood “slot” velocity (the opening at the rear of the hood between the baffle plates).

• Measurements are recorded on a data logger while

opening and closing the sash. The test performed spans

5 minutes (30-60-30-60-30-60-30). The sash is closed

for 30 seconds and opened to the design opening for 60

seconds during each cycle and closed at the end of the

test. The results documented are the:

– 1. Speed of Response

– 2. Time to Steady State

– 3. Repeatability of Flow Response


82

Local Volume Smoke StudyLocal Volume Smoke Study

• Pass smoke source

– Under front airfoil

– Around entire sash

opening, 6” behind sash

– In an 8” diameter circle

along the back wall of the hood

– Along all equipment and at the work top of the hood

Large Volume Smoke StudyLarge Volume Smoke Study

• Release large volume of smoke along centerline, 6” behind sash.

• Report where all refluxing or escapage of air is coming from.

• Record all corrective actions taken.

83

• Large volume smoke at same locations as local

volume smoke study

– Under the airfoil

– Along the side walls

– Along the work surface

– Around any equipment inside the hood

– Inside the hood, above the bottom of the sash

– For horizontal or combination sash hoods, release smoke

behind the sash

– In the cavity above the hood opening

– Outside the hood


Tracer Gas TestsTracer Gas Tests

• Positional Control Test

• Leakage Test

• Sash Movement Effect Test

• Walk-by Test

84

• Height of mannequin change

– Anthropomorphic data acquired states the

average laboratory worker height is 5’ 4.5” tall.

• Lowers the breathing zone creates a bigger challenge

to the hood, as the breathing zone is now closer to an

18” design opening.

• Common leakage from a Chemical Hood is seen along

the bottom of the sash, when opened (another

common point of leakage is in front of large equipment

placed in the hood).


• Positional Control Test

– A 30 second “delay” is initiated prior to the 5-

minute Positional Test to allow the analyzer cell to fill completely.

• Peripheral Scan

– In addition to the normal scan around the sash

opening, a scan is performed under the airfoil.

Upcoming ChangesUpcoming Changes

85

• Sash Movement Effect Test

– The test is performed in the same manner as the

1995 ASHRAE 110 Standard, however the time

for each section has changed:

• 60 seconds after the start of gas generation, start the

analyzer to log readings every 1 second

• After 60 seconds, open the sash to the design sash

opening

• After 60 seconds, close the sash

• Repeat three times

• Calculate the 45-second rolling average for each test.

Record the maxim rolling average associated with each

opening of the sash

• The SME is the maximum rolling average determined


WalkWalk--by Test (New)by Test (New)

• Tester walks behind mannequin at a rate of 3 feet per second

• Parallel to sash at a distance of 24” away from sash plane.

• Simulates lab personnel movement effect by an operator of a laboratory chemical hood.

• Report the maximum concentration

86

QuestionsQuestions

Cleanroom and Cleanroom and Containment Suite Containment Suite

UpdatesUpdates

87

Two Types of Areas inTwo Types of Areas in

• Pharmaceutical Sterile Manufacturing Facilities

Review of Typical Sterile Review of Typical Sterile Manufacturing SuiteManufacturing Suite

• Class 1,000 to Class 100,000 (ISO Class 6 to ISO Class 8) Non-Unidirectional Support Areas (Controlled Areas)– Dilution control

• Class 100 (ISO Class 5) UnidirectionalFilling Areas

(Critical Areas)– Flow Control

88

Filling Room

Class 100 (ISO Class 5)

Critical Area

Gown Room

Class 100,000

Controlled

Area

Equipment

Pass-Thru

Class 100,000

Controlled

Area

Corridor Class 10,000 Controlled Area

Filling Room

Class 100 (ISO Class 5)

Critical Area

Typical Pharmaceutical Cleanroom LayoutTypical Pharmaceutical Cleanroom Layout

Warehouse / Ambient / Uncontrolled

ISO Class 8 ISO Class 8

ISO Class 7

Class 100 VLF

Isolator

BSC

Class 100,000 Corridor

Class 10,000 Room

Class 10,000 Room

Typical Pharmaceutical Cleanroom LayoutTypical Pharmaceutical Cleanroom Layout

(ISO Class 7) (ISO Class 7)

(ISO Class 5)

(ISO Class 8)

89

Critical AreasCritical Areas

• The “critical” area is where sterilized product or container/ closures are exposed to the environment.

Unidirectional Airflow Rooms Unidirectional Airflow Rooms

(Laminar)(Laminar)• Most common application of unidirectional

Room is vertical flow. Air flows in a downward direction from filters located in room ceiling and returns to sidewall returns or perforated flooring. IMPORTANT

– Pharmaceutical industry does not use perforated flooring.

• Airflow in unidirectional rooms may be horizontal flow walls with 100% coverage in supply side wall.

• Unidirectional – previously referred to as Laminar Flow

90

HEPA

RETURN RETURN

Unidirectional Room

HEPAHEPAHEPA HEPA

FLOW CONTROL

Controlled AreasControlled Areas

• The “controlled” area is where unsterilized product, in process

materials, & container/closures are

prepared.

91

Nonunidirectional Airflow Nonunidirectional Airflow RoomsRooms

• Air flows from filters in various ceiling or wall locations and is returned through ceiling or low wall returns. IMPORTANT

• Filters may be distributed at equal intervals or be clustered over critical process areas.

HEPAHEPA

RETURN RETURN

Non - Unidirectional Room

DILUTION CONTROL

94

• ISO Std 14644-1:1999 “Cleanrooms and

associated controlled environments - part

1 Classification of Air Cleanliness”

– Is currently in FDIS status with areas still under review and serious contention

• 5.0 um reporting on classification chart

• Use of statistical analysis or drop

• Determining minimum number of sample locations

• Requiring particle counters to be calibrated by ISO Std 21501-4 methods

Industry UpdatesIndustry Updates

• Useful reference sources

– CDC/NIH Biosafety in Microbiological and Biomedical Laboratories – 5th edition

• HHS Pub No (CDC) 21-1112

• General guidance, little actual acceptance criteria

– Primary Containment for Biohazards: Selection, Installation, and Use of Biosafety Cabinets. 3rd edition

• Now Appendix A of 5th Edition

• Ref: http://www.cdc.gov/biosafety/publications/

Containment Suite InformationContainment Suite Information

95

– Takes over where BMBL 5th edition leaves off

– Provides specific guidance on room pressurization, alarm conditions

• Formerly called the NIH Design Policy and Guidelines

Other SourcesOther Sources

NIH Design Requirements

Manual for Biomedical

Laboratories and Animal

Research Facilities (DRM)

• Manual 242.1 USDA ARS Facilities Design Standards

– Biosafety Level 1 (BSL-1).



– Biosafety Level 3 Agriculture (BSL-3Ag). Used with pathogens that present a risk of causing infections

of animals and plants and causing a great economic

harm. (Example: Foot and Mouth Disease)


Other SourcesOther Sources

96

Questions – Raise your hand or contact us by email: [email protected] or

telephone (800) 523-9852

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