Compliance & Biocontainment

Biological Safety Cabinets

Derrick Teo
Regional Product Manager

The world leader in serving science

1
 Agenda
• Biosafety Cabinetry Certification
➢ NSF/ANSI 49
➢ EN12469

• Mechanics of Containment
➢ The Soul of a BSC

• Working in Biological Safety Cabinet

➢ What are aseptic techniques
➢ Tips perfecting your aseptic techniques

• The Thermo Scientific Solution

2
What is a Biological Safety Cabinet (BSC)?

• A ventilated cabinet with negative pressure

filtration, designed to protect

➢ i) The Operator and the Environment from

exposure to Biological Aerosols generated in an
experiment.

➢ The Sample/Product from exposure to any

Airborne Contamination present outside the
cabinet.

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 Biosafety Cabinetry Certification: NSF vs EN

NSF/ANSI 49 EN12469
Biological Protection Biological Protection
Cabinet Integrity Cabinet Integrity
Filter Leak Test Cleanability
Downflow Velocity Sterilizability
Inflow Velocity Filter Leak Test
Airflow Smoke Patterns Downflow Velocity
Noise Level Inflow Velocity
Lighting Intensity Airflow Alarms
Vibration Test Noise Level
Stability Tests Lighting Intensity
Drain Spillage Leakage Vibration Test
Motor/blower Liquid Spillage
Performance

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 NSF/ANSI 49 Certification

• All NSF/ANSI 49 certified BSCs are listed on the

National Sanitation Foundation (NSF) website
@ http://info.nsf.org/Certified/Biosafety/

• NSF classifies BSCs into

➢ 3 Classes - Class I, Class II, Class III
➢ Class II is further subdivided into
o Type A1
o Type A2
o Type B1
o Type B2

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 EN12469 Certification

EN12469 classification
• 3 Classes:
Class I, Class II, Class III
➢ No further sub-division

How do you tell if a BSC is

EN12469 certified?
➢ Look at the TUV online Listings
@ www.tuv-nord.com
➢ Go to
Certification > Consumer goods >
Biotechnological safety

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 NSF/ANSI 49 & EN12469
▪ There are THREE Classes of BSCs

Class I Class II Class III

Personal Protection Personal Protection
Environment Protection Environment Protection
Sample Protection

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 NSF/ANSI 49 Subdivision - Class II
• Under NSF / ANSI 49, Class II can be classified into the following 4 types:
Total
Exhaust

30%

70%
0.51m/s
0.38m/s 100fpm
75fpm 0.51m/s
0.51m/s
100fpm
100fpm

Type B1 Type B2
Type A1 Type A2 40% recirculated; 60% 0% air recirculated;
70% recirculated; 30% exhausted to a exhausted air Use Use with dedicated
30% exhausted to facility exhaust with dedicated exhaust duct
room; system; exhaust duct Reserved for works where
No longer allowed Handle minute quantity Handle minute quantity of volatile material
under NSF / ANSI 49 of volatile hazardous volatile hazardous recirculation must be
(2009) material if properly material avoided
exhausted
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 Mechanics of Containment
The Soul of a BSC

• Balanced inflow and downflow

➢ Personal protection
➢ Product protection

Balanced
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 The Soul of a BSC

• Product Protection

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 The Soul of a BSC
• Product Protection

• Protection from Cross

Contamination

11 Proprietary & Confidential | derrick.teo@thermofisher.com | April-2021

 When the Airflow is Out of Balance…

 Inflow /  Downflow  Inflow /  Downflow

NO Product Protection NO Personal Protection

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 Clean Benches & Fume Hoods are NOT BSCs

Vertical Horizontal

Clean Bench / Laminar Flow Cabinets Fume Hoods

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 What are Aseptic Techniques?

Aseptic technique, designed to provide a barrier

between the microorganisms in the environment and the
sterile cell culture

Elements of aseptic techniques

• Sterile work area
• Good personal hygiene
• Sterile reagents and media
• Sterile handling

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 Major Types of Biological Contamination

Note : Culture also can become cross-contaminated with other cell lines
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 How to avoid Biological Contamination

Note : Washing hands before

handling cells or performing culture
work ensures you remove bacteria
and microscopic dead skin
particles.
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 Tips for
Perfecting Your
Aseptic
Techniques
Aseptic Techniques in Cell Culture

Good Personal Hygiene

Start with Yourself

• Washing hands before handling cells or performing
culture work ensures you remove bacteria and
microscopic dead skin particles

• Disinfect gloves sufficiently and repeatedly

• Select gloves model covering the wrist

• Wearing personal protective equipment also reduces

the probability of contamination from shed skin as well
as dirt and dust from your clothes

*Fact : Humans carry 10K contaminable microorganisms per square centimeter of skin

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 Aseptic Techniques Tips and Tricks

Always clean A 70% ethanol

Don’t Clean each of
the hood before the items you will wash kills
breathe or
and after use – need with 70% microorganisms
talk into the
don’t use ethanol before or that could
cell culture
ethanol near as soon as it contaminate
hood
open flames enters hood your culture

Position your
chair and body
correctly to
prevent tension
and to avoid risk
of contamination

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 Work Surface Layout in a BSC

• Minimize turbulence at the front opening

➢ Operator movements reaching into and pulling arms out of BSC work area

• Minimize importation of particles

➢ Unnecessary material in work area
➢ Wipe down and lay out supplies

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 DOs and DON’Ts in a BSC

• Back grills are

blocked

• Plastic are exposed to

UV

• Work Surface are

shadowed & not
under the UV

• Sash not completely

close when UV is on

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 The Thermo Scientific Solution

2222
 Be 'Smart', The 4 Cs

The 4 “Cs” of BSCs:

C C
C C

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 Containment - Problems with Single Motor BSC
• Every Class II BSC has 2 filters - Downflow Filter and Exhaust Filter.
• The two HEPA filters are loaded to different extents.
• Downflow Filter is loaded first - 70% of total air is downflow.
• Motor tries to blow faster to compensate for the downflow reduction.
• A stronger exhaust is resulted because the exhaust HEPA filter is less loaded - 30% of total air is exhaust
• Stronger exhaust = stronger inflow, sample contamination is more likely.
• Correction by restricting exhaust using mechanical damper. Must involve service engineer. Downtime is expected.

30% as
Exhaust Exhaust Filter

70% as Downflow Filter

Downflow

Compensating to maintain TOTAL flow does not preserve air balance.

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 Containment - Thermo Scientific SmartflowTM

• Dual-blower DC motor technology

➢ SmartFlow™
• Ensures a safe working environment, even in between
certifications
o Independent control of inflow/exhaust and downflow
o No need for manual airflow control of a damper
o Motor speed automatically compensates for filter loading
o Exhaust motor automatically compensates in response
to HEPA loading
o Downflow motor compensates in response to exhaust Exhaust Motor
motor

Downflow Motor

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 Cost - AC vs DC Motors

• Reduced Energy Consumption and Heat Output

➢ DC Motors offer reduced energy consumption, heat output
➢ Night-set-back or reduced flow mode minimizes energy during
low use, and still maintaining the clean environment in the cabinet

• Highest Motor Reliability

➢ Even with multiple motors, >100,000 hrs

Motor Type Est. Life (hrs.)

• 10% Longer Filter Life
AC 20,000
➢ Optional 8 inch window reduces inflow
DC-ECM 50,000
Thermo ebm DC >100,000

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 Cost - AC vs DC Motors

Blower on Blower Blower

Energy consumption Blower on Unit Off Blower
and Light On reduced reduced
and Light Unit Off with UV off and
in watts and Light and UV
(Operational) Out On Light On
Off On

BSC “T”, BLDC Motor,

10” high window 208 142.5 5.5 25.9 66.5 87.0 67.0
opening
• 75% more efficient
BSC “A”, AC Motor, 10”
841 780 2.2 No UV N/A N/A 61.0
high window opening

BSC “B”, AC Motor, 8”

790 725 3.7 59.1 N/A N/A N/A
high window opening

BSC “C”, AC Motor, 10”

660 602 0.0 No UV N/A N/A 61.8
high window opening

University of Michigan Field Study Table 1 – Energy consumption in watts of BSCs with 4 foot
nominal width cabinets in different modes.

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 Comfort
A cabinet that stresses and fatigues the worker so they have a greater potential
for accidents, autoinoculation or unwise decisions is an unsafe cabinet.

• 10˚ sloping cabinet front

• Low noise level
• Bright workspace
• Unique armrest 50

• Ergolign lab stool

• Adjustable base stands

Our end users deserve a better

work environment!

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• Unique Design to Avoid Turbulence
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 Convenience - SmartPort

• SmartPort

➢ Provides a clean and safe method of routing

vacuum tubing and cables through the side Inside
BSC
wall of the BSC Work
Area
➢ Safe and clean access for cables and hoses

Outside
BSC
in lab

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 Convenience - SmartCleanTM
• SmartCleanTM
➢ Safe cleaning for all the BSC work area
➢ Cleaning the upper inner glass sash with inflow protection

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 Convenience - SmartCleanTM
➢ SmartCleanTM offers a window cleaning position that
provides the user access to interior of window sash
➢ SmartCleanTM also provides easy access to HEPA filter
for scanning during the HEPA filter integrity test.

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Thermo Scientific BSC Portfolio
• NSF/ANSI 49 Certified

1300 Series 1500 Series

Class II Type A2 BSC Class II Type B2 BSC HERAguard ECO
Laminar Flow Benches
• EN 12469 Certified

*Maxisafe 2030i is a Triple-Filtered BSC certified to EN12469 & DIN12980

DIN 12980 certification: Safety cabinets for handling cytotoxic substances

This requires the highest personnel, product and environmental protection

when working with CMR (carcinogenic, mutagenic or toxic to reproduction)
compounds, including preparation of hazardous drugs in healthcare
compounding pharmacies and facilities.

MSC Advantage HeraSafe 2030i *MaxiSafe 2030i

Class II BSC Class II BSC Class II BSC
 Thank you
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