Introduction To Biosafety Cabinets - Part II 2

Introduction to
Biosafety Cabinets
Part II
Faisal Alrasheedi – Managing Director;
Masarat for Accreditation
Welcome
18/10/2022 2
An Introduction to Biosafety Cabinets, Part I - Engr. Faisal Alrasheedi; Masarat for Accreditation
About the Instructor
• Bachelor of Biomedical engineering background with a master degree

in health & hospital administration.
• Diploma of further qualifications of entrepreneur
• Founder and managing director of Masarat for Accreditation
• > 12 years in cleanrooms and controlled environment
• Member in CETA, ABSA, IEST and among others cleanroom and
contamination control associations
• Participated in many healthcare mega projects.
3
18/10/2022 An Introduction to Biosafety Cabinets, Part I - Engr. Faisal Alrasheedi; Masarat for Accreditation
RECAP OF PART I
• Biosafety Level
• Types of Laboratory Ventilation Equipment
• Types of Biosafety Cabinets
5
18/10/2022 An Introduction to Biosafety Cabinets, Part II - Engr. Faisal Alrasheedi; Masarat for Accreditation
Today’s proposed learning outcomes
• HEPA Filters Theory

• Testing and Certification
• Decontamination
4
HEPA FILTER THEORY
 Filter – A device for removing impurities

 HEPA – High Efficiency Particulate Air
 Micron – micrometer or 1 x 10-6m
 Efficiency – In engineering term, it is Output/Input and express in % and it will
never exceed 100%
 A filter can remove either particles or gas
 Typically, what are gas filters made of?
6
WHAT IS A MICRON?
Human Hair 100 µm Visibe30-50 µm Bacteria 5-10 µm
18/10/ 16
2022 An Introduction to Biosafety Cabinets, Part II - Engr. Faisal Alrasheedi; Masarat for Accreditation
How
Large is
a
Micron?
17
WHAT IS A MICRON?
7
HEPA/ULPA/SULP FILTERS
 High Efficiency Particulate Air Filters – HEPA Filters
 Ultra Low Penetration Air Filters – ULPA Filters
 Super Ultra Low Penetration Air Filters – SULPA Filters
8
HEPA FILTERS
High Efficiency Particulate Air Filters – HEPA Filters
Minimum particulate removal of either 99.95%, 99.97% or 99.99% for particles of 0.3
micron size.
Maximum 250 pascal (1 Inch w.g.) pressure drop when clean and at rated flow.
10
ULPA FILTERS
Ultra Low Penetration Air Filters – ULPA Filters
Minimum particulate removal of either 99.999%, for particles of 0.1 to 0.2 micron
size.
10
HEPA/ULPA FILTERS
Super Ultra Low Penetration Air Filters – SULPA Filters
Minimum particulate removal of either 99.9999%, for particles of 0.1 to 0.2 micron
size.
10
HEPA FILTER MEDIA
 The Media is made up of an assembly of fibres that are

randomly laid perpendicular to the airflow
 The fibres may range in size from less than 1 μm to greater

than 50 μm in diameter.
 Filter packing density may range from 1% to 30%.
 Pleated Borosilicate Fibres with acrylic binders
11
HEPA FILTER COMPONENTS
• Filter Media
• Separators – aluminium, medium, glue

dimples
• Filter Frame – wood, aluminium, galvanised

steel, polypropylene
• Gasket
9
HEPA FILTER PRINCIPAL
• How does Particulate Filter capture particles?
• Can HEPA be used for gas absorption?
• What should you do when your samples are biohazard and has chemical trace?
1٢
1٢
1٢
HEPA FILTER
PRINCIPAL
17
1٣
1٣
STANDARDS - BSC
• NSF/ANSI Standard 49 (Biosafety Cabinetry: Design, Construction, Performance, and

Field Certification
• BS EN 12469:2000 (Biotechnology Performance criteria for microbiological safety

Cabinets)
21
STANDARDS - HEPA
• IEST RP-CC- 001.6 (published 04/01/2016)

• Recommended practice for specifying HEPA filters.
• STANDARD NSF/ANSI standard 49-02 requires use of ''type C,F,J,K'' filters per this
document
• IEST RP-CC-034.4 (Published 04/01/2016)
• This recommended practice is for referencing HEPA filter leak testing requirements.
It is be the basis of the revised HEPA integrity testing section for NSF/ANSI Standard
49-02.
• IEST RP-CC-013 .3 (2012)
• Calibration and verifying equipment used in characterizing cleanrooms and for
determining intervals of calibration.
21
TESTING & CERTIFICATION
• HEPA FILTER LEAK TESTING - Filter integrity testing
• Downflow Velocity Test
• Inflow Velocity Test
• Smoke Pattern Test
• Particle Count Test
• Site installation Assessment Tests
• Worker comfort and safety (formerly called secondary tests)
21
HEPA FILTER LEAK TESTING - Filter integrity testing
• Checks that the HEPA filter is intact and has no leaks

• Checks that the Gasket is not leaking
• Scan versus Average
21
AIRFLOW TESTING

Measures the velocity of air moving through the cabinet work space
• Acceptance
The average downflow velocity must be within +/-5 fpm (+/-0.0254m/s) of
the value specified.
16
AIRFLOW TESTING

Measures the velocity of air moving through the cabinet work space
• Acceptance
The average downflow velocity must be within +/-5 fpm (+/-0.0254m/s) of the
value specified.
21
SMOKE PATTERN TEST - AIRFLOW
SMOKE PATTERN TEST
• Airflow along the entire perimeter of the work access opening is inward
• Airflow within the work area is downward with no dead spots for refluxing
• Ambient air does not pass on or over the work surface
• There is no escape to the outside of the cabinet at the sides and top of the
window
Tests
Down flow Test
View screen Retention test
Work opening Edge Retention Test
Sash/ window seal Test
1٥
WORKER COMFORT AND SAFETY
Purpose
• To help prevent worker fatigue which may result in mistakes and accidents
• Random electrical shocks plus extremes in noise, lighting and vibration will quickly
lead to fatigue.
Tests
• Electrical
• Lighting
• Vibration
• Noise
21
DECONTAMINATION OF BSC
Disinfection
Chemical or physical treatment that destroys most vegetative microbes but not spores
Sterilization
Total destruction of all living organisms
Decontamination
Destruction of microorganisms to some lower safe level
21
When to Decontaminate
• Prior to performing cabinet maintenance
• Prior to relocating
• Prior to a change in research
• Prior to disposal
21
Decontamination Processes
• Formaldehyde
• Chlorine dioxide
• Hydrogen peroxide
21
Formaldehyde
• Changes DNA structure (not an oxidizer)
Advantages
• Very well characterized

• Inexpensive
Issues
• Potential carcinogen
• Potential residue (fall – out)
• Hydrogen chloride in the presence of formaldehyde, at ambient conditions will form
the carcinogen, bis (chloromethyl) ether (BCME).
21
Hydrogen peroxide (H2o2) Vapor
• General oxidation
Advantages
• Safe by – products (water and oxygen)

• No residue
• Industry accepted
• Not potential carcinogen ( unlike formaldehyde)
• Steris – VHP – targets no condensation
• Bioquell – Clarus – targets micro – condensation
21
Hydrogen peroxide (H2o2) Vapor
Issues
• Instability of HP toward condensation and /or decomposition
• Under certain conditions may not be effective at penetrating filters or cellulose

materials
• May effect decontamination or aeration time
• Potentially corrosive
• Validated procedures not yet published in NSF/ANSI 49
21
Chlorine Dioxide (CLO2)
• Selective oxidation
Advantages
• Safe by products (oxygen and salt)

• No residue
• Not flammable
• True gas – no condensation issues
• Reputation for use in Anthrax decontamination
• Validated procedures published in NSF/ANSI 49
21
Chlorine Dioxide (CLO2)
Issues
• Potentially corrosive if chlorine gas (Cl2) is present
• Current low PEL limit (O.1 ppm)
21
Overview
We have covered in session I & II :
• Biosafety Principles
• Laboratory Ventilation Equipment
• Types of Biological Safety Cabinet
• HEPA Filters Theory
• Testing and Certification
• Decontamination
61
Questions and answers
18/10/ 62
2022 An Introduction to Biosafety Cabinets, Part II - Engr. Faisal Alrasheedi; Masarat for Accreditation
falrasheedi@m4acc.com

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Introduction to

• Bachelor of Biomedical engineering background with a master degree

• HEPA Filters Theory

 Filter – A device for removing impurities

Human Hair 100 µm Visibe30-50 µm Bacteria 5-10 µm

 High Efficiency Particulate Air Filters – HEPA Filters

 Ultra Low Penetration Air Filters – ULPA Filters

 Super Ultra Low Penetration Air Filters – SULPA Filters

High Efficiency Particulate Air Filters – HEPA Filters

Ultra Low Penetration Air Filters – ULPA Filters

Super Ultra Low Penetration Air Filters – SULPA Filters

 The Media is made up of an assembly of fibres that are

 The fibres may range in size from less than 1 μm to greater

 Filter packing density may range from 1% to 30%.

 Pleated Borosilicate Fibres with acrylic binders

• Separators – aluminium, medium, glue

• Filter Frame – wood, aluminium, galvanised

• How does Particulate Filter capture particles?

• Can HEPA be used for gas absorption?

• NSF/ANSI Standard 49 (Biosafety Cabinetry: Design, Construction, Performance, and

• BS EN 12469:2000 (Biotechnology Performance criteria for microbiological safety

• IEST RP-CC- 001.6 (published 04/01/2016)

• HEPA FILTER LEAK TESTING - Filter integrity testing

• Downflow Velocity Test

• Inflow Velocity Test

• Smoke Pattern Test

• Particle Count Test

• Site installation Assessment Tests

• Worker comfort and safety (formerly called secondary tests)

• Checks that the HEPA filter is intact and has no leaks

• Downflow Velocity Test

• Downflow Velocity Test

• Ambient air does not pass on or over the work surface

Total destruction of all living organisms

Destruction of microorganisms to some lower safe level

• Prior to performing cabinet maintenance

• Prior to a change in research

• Changes DNA structure (not an oxidizer)

• Very well characterized

Hydrogen peroxide (H2o2) Vapor

• Safe by – products (water and oxygen)

Hydrogen peroxide (H2o2) Vapor

• Instability of HP toward condensation and /or decomposition

• Under certain conditions may not be effective at penetrating filters or cellulose

• May effect decontamination or aeration time

• Validated procedures not yet published in NSF/ANSI 49

Chlorine Dioxide (CLO2)

• Safe by products (oxygen and salt)

Chlorine Dioxide (CLO2)

• Potentially corrosive if chlorine gas (Cl2) is present

• Current low PEL limit (O.1 ppm)

We have covered in session I & II :

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