biological safety cabinets: choice criteria for a proper ... · resuming chart en 12469:2000....

Biological Safety Cabinets: choice criteria for a proper user’s safety

Pietro Oliverio

Faster s.r.l.

Pietro Andrea OliverioExport Area [email protected]

Agenda

1. Biological Safety Cabinets: classes, EU standard vs USA standard and relatedperformances

2. Risk analysis and cabinet’s choice criteria according to the manipulatedproduct

Biological Safety Cabinets: classes, EU standard vs USA standard

There are two main worldwide standards for the classification of Biological Safety Cabinets:

EU Standard, EN 12469:2000 USA Standard, NSF/ANSI 49

Biological Safety Cabinets: Class classification according to EN 12469:2000 EU standard

EU Standard, EN 12469:2000

Class I cabinets

Class II cabinets

Class III cabinets


Class I cabinets100% EXHAUST AIR

Product protection

User protection

Environment protection

OPERATING PERFORMANCE:

INFLOW VELOCITY: > 0,7 m/s - 1,0 m/s

NO DOWNFLOW

H14 HEPA FILTER

ROOM AIR

Class II cabinets

H14 HEPA FILTER

H14 HEPA


Product protection

User protection


ROOM AIR

RECIRCULATING AIR BY LAMINAR FLOW

EXHAUST AIR OPERATING PERFORMANCE:

INFLOW VELOCITY: ≥0,4 m/s

DOWNFLOW VELOCITY: 0,25 – 0,5 m/s

Class III cabinets

H14 HEPA FILTERH14 HEPA FILTER

H14 HEPA FILTER Product protection N.A.

User protection


ROOM AIREXHAUST AIR


OPERATING PRESSURE:

– 200 Pa IN COMPARISON TO ENVIROMENT PRESSURE


Class Downflowvelocity

Inflow velocity Ducting Air handling Product protection

User protection Environment protection

I N.A. > 0,7 m/s - 1,0 m/s Optional ** 100% exhausted0% recirculated

NO YES YES

II 0,25 – 0,5 m/s > 0,4 m/s Optional ** N.A. YES YES YES

III N.A. N.A.* Optional ** N.A. N.A.*** YES YES

Resuming chart EN 12469:2000


* Physical protection barrier thanks to the presence of front screen with gloves, guaranteed containment thanks to leak tests with -200 Pa pressure

** Ducting to be evaluated according to user’s inetrnal risk analysis

*** Product protection but not compulsory laminar flow conditions

Biological Safety Cabinets: Class classification according to NSF/ANSI 49 USA standard

USA Standard, NSF/ANSI 49

Class I cabinets

Class II cabinets

• Class II A1• Class II A2• Class II B1• Class II B2• Class II C1

Class III cabinets


Class II A1-A2 cabinets

H14 HEPA FILTER

H14 HEPA

30% EXHAUST AIR

70% RECIRCULATING AIRBY LAMINAR FLOW


INFLOW VELOCITY:

≥ 0,38 m/s PER CLASSE II A1

≥ 0,51 m/s PER CLASSE II A2


Product protection

User protection


ROOM AIR

Class II B1 cabinets

H14 HEPA FILTER

H14 HEPA

50% EXHAUST AIR

50% RECIRCULATING AIR BY LAMINAR FLOW

ROOM AIR

DUCTING


Product protection

User protection



INFLOW VELOCITY: ≥ 0,51 m/s


Class II B2 cabinets

H14 HEPA FILTER

H14 HEPA

100% EXHAUST

LAMINAR AIR FLOW

ROOM AIR

DUCTING


Product protection

User protection





ROOM AIR

Class II C1 cabinets

H14 HEPA FILTER

H14 HEPA

50% EXHAUST AIR

50% RECIRCULATING AIR BY LAMINAR FLOW

ROOM AIR


Product protection

User protection





Classe Downflowvelocity

Inflow velocity Ducting Air handling Product protection

User protection Environment protection

I N.A. ≥ 0,38 m/s Optional 100% exhausted0% recirculated

NO YES YES

II-A1 0,25 – 0,5 m/s ≥ 0,38 m/s Optional 30% exhausted70% recirculated

YES YES YES

II-A2 0,25 – 0,5 m/s ≥ 0,51 m/s Optional 30% exhausted70% recirculated

YES YES YES

II-B1 0,25 – 0,5 m/s ≥ 0,51 m/s Required 50% exhausted50% recirculated

YES YES YES

II-B2 0,25 – 0,5 m/s ≥ 0,51 m/s Required 100% exhausted0% recirculated

YES YES YES

II-C1 0,25 – 0,5 m/s ≥ 0,51 m/s Optional 50% exhausted50% recirculated

YES YES YES

III N.A. N.A. Optional N.A. N.A. YES YES

Resuming chart NSF/ANSI 49


Risk analysis and cabinet’s choice criteria according to the manipulated product

How/when choose the right cabinet? Mmmmmh….

Risk analysis and cabinet’s choice criteria according to the manipulated productGuideline for the correct choice of biosafety cabinet:

What should the laboratory user do?

1. Microbial risk analysis 2. Laboratory classification (BSL 1/2/3/4)

3. PPE(Personal Protective Equipment) and CPE (CollectiveProtection Equipment) choice 4. Good laboratories techniques

adoption(equipment use, Emergency procedures, products sterilization, etc…)

CDC (Centers for Disease Control and Prevention) is a national public health institute in USA, worldwide recognized for the classification of pathogens in accordance with their risk.


CDC identifies 4 different risk groups of pathogens with related laboratory biosafety levels (BSL) 1/2/3/4.


CDC Classification of 4 groups of Biological Hazardous OrganismsRisk Group 1 Not known to consistently cause diseases in healthy adults.

E.G.. Escherichia coli

Risk Group 2 Agents associated with human disease. Routes of transmission include per-cutaneous injury, ingestion, mucousmembrane exposure.E.G.. HIV

Risk Group 3 Indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route ofexposure. E.G.. Tubercolosis or SARS-CoV-2

Risk Group 4 Dangerous/exotic agents which post high individual risk of aerosol-transmitted laboratory infections that arefrequently fatal, for which there are no vaccines or treatments.Agents with a close or identical anti-genic relationship to an agent requiring BSL-4 until data are available toredesignate the level. Related agents with unknown risk of transmission. E.G.. Ebola


Risk Group associated to Biosafety LevelRisk Group BSL Equipment

1 1 - Base PPE + work bench

2 2 - Base PPE + Class I-II biosafety cabinet

3 3 - Containment PPE + Class I-II biosafety cabinet

4 4 – Maximum Containment PPE + Class III biosafety cabinet

• The EN12469 standard recognizes one type of Class II BSC, which is generally equivalent to the Class II, Type A2 BSC as specified by NSF.

• EN Class II and NSF Class II, Type A2 BSC accounts for approximately 95% of the global install base of any class or type of BSC. It is the most commonly used BSC, primarily due to the versatility and high levels of protection offered.

• Globally, there is a misconception that the safety level of the class II subcategories (A2, B2 etc..) differs between each other. All sub-categories of class II are equally safe from a microbiological point of view and provide operator and product protection.



• Volatile or toxic chemicals should not be used in BSCs that recirculate exhaust air to the room, i.e. Class IIA2 cabinets. For this reason, NSF/ANSI 49 introduces class B for chemicals.

• Class IIB1 cabinets are acceptable for work with minute amounts of volatile chemicals and radionuclides.

• Class IIB2 cabinet, also called a total exhaust cabinet, is necessary when significant amounts of radionuclides and volatile chemicals are expected to be used.

Thanks for your attention

Pietro Oliverio

Faster s.r.l.

biological safety cabinets: choice criteria for a proper ... · resuming chart en 12469:2000....

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