CHALLENGES IN CERTIFYING BIOSAFETY CABINETS

Mary Ann Sondrini, EdMExecutive Director, Eagleson Institute

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 1

Biosafety CabinetsMust be certified (tested) on regular basis to balance airflows and prevent leaks in the HEPA filters

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 2

Eagleson InstituteNonprofit educational organization with a mission to globally promote the principles and practices of health and safety in the life sciences communitycommunity

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 3

Global Biosafety Cabinet Certification Training ProgramProgram

QatarBarbados

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 4

Challenges

• PART I: Challenges in the United StatesPART II: Challenges in Low Resource Countries• PART II: Challenges in Low Resource Countries

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 5

Challenges in United States1. Staying up-to-date on changes to NSF/ANSI 49

2008• Chlorine dioxide added as a decontamination agent2010

l ll h i i i i d• No longer allows Type A1 BSCs to have exterior positive pressure contaminated plenums

• Type A1 and A2 BSCs need to be canopy connected, and direct connected ones shall no l b id d i li ( f t b i 2015)longer be considered in compliance (enforcement began in 2015)

• NSF accredited certifiers can loose accreditation if they certify Type A BSCs that are direct connected (enforcement began in 2015)

• Canopy connected BSCs need to have exhaust alarms which must be tested

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 6

• Canopy connected BSCs need to have exhaust alarms, which must be tested

Challenges in United States

2017• Type C1 BSCs were added• Type C1 BSCs were added• Vaporized Hydrogen Peroxide added as a decontamination agent

2018• New standard – minor changes

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 7

Challenges in United States 2. Determining if BSC certifiers are qualified

• Are they accredited?• Do they leave detailed documentation for each BSC tested?

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 8

What Should A Certification Report Include?• General information

• Type of cabinetyp• Manufacturer, Model, Serial number• Location• Venting criteria

- To room, to roof, exhaust fan, type of damper, BMS, other hoods on same system?on same system?

• Name of certifier- Print and sign

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 9

What Should A Certification Report Include? • Basic Information on Tests Performed

• Brief description of each test p- This can be provided on a referenced SOP- Refer to any appropriate industry standards

• Acceptance criteria for each test• Pass/Fail statement for each test and for the unit overall

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 10

What Should A Certification Report Include? • Detailed Information on Tests Performed

• Airflow readings per NSF- Each reading in a corresponding grid- Average of readings- Methods used to determine the readings- Methods used to determine the readings

• HEPA filter - Upstream aerosol challenge and how determined (calculate vs measure)p g ( )- Maximum leak penetration in percent and method used (scan vs probe)- Diagram showing location of leaks

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 11

What Should A Certification Report Include? • Test equipment used for each test

- Manufacturer- Model and Serial number- Calibration date and calibration due

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 12

Resources

NSFNSF/ANSI 49 – 2018 Annex E  and F• E: Biosafety Cabinet Selection, Installation, Lifespan, and Decommissioning• F: Field Tests

CDC/NIHCDC/NIHBMBL – Appendix A• Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 13

Challenges in Low Resource Countries• Very few trained personnel• BSCs come from all parts of the

world• BSCs built to different standards

BSC t b ki t ll• BSCs may not be working at all• Certifiers need to figure out how

they work, diagnose problems, andthey work, diagnose problems, and develop strategy for repairing without manualDiffi lt t bt i t

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 14

• Difficult to obtain parts

Every Country Has It’s Own StoryKenya Haiti Ethiopia

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 15

Success Stories• Significant increase in number of BSCs being certified.• Much more training related to proper use of BSCs is taking place.• Certification programs are starting to grow roots.

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 16

Challenges• Certifier Credibility

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 17

Challenges • Calibration of testing equipment

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 18

Challenges • Obtaining Consumable Supplies and Replacement Parts

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 19

Challenges • Program Leadership Needed

- System for keeping track of BSCs and certification reports- System for professional development and oversight of certifiers- System for storing, transporting and calibrating certification equipment- Budget for supplies- Budget for supplies- Time planned into work schedule

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 20

Thank you!Thank you!

Mary Ann Sondrini EdMMary Ann Sondrini, EdMExecutive Director, Eagleson Institute

msondrini@eagleson.org | www.eagleson.org @ g g | g g

CHALLENGES IN CERTIFYING BIOSAFETY CABINETS© 2019 | Eagleson Institute | www.eagleson.org SLIDE 22