View
5
Download
0
Category
Preview:
Citation preview
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
Recommended