BD Biosafety Influx BioProtect Report

THE BAKER COMPANY
161 Gatehouse Rd., Sanford, Maine 04073 USA

“Creating Immaculate Atmospheres”
Microbiological Testing Report 3/14/12

BioProtect IV with Influx Flow Cytometer
Model BP-504-5 BD Influx Baker Doc. #BAKT 185
Customer:
BD Biosciences
Introduction:
The safety cabinet was airflow balanced to a set point velocity of 55 feet per minute down flow
and 105 feet per minute intake at an 8” sash opening prior to microbiological testing. Preliminary
smoke tests were conducted to identify potential airflow turbulence which may affect cabinet
performance. A smoke visualization test demonstrated turbulent air was curling around the top
and when the Influx front door was in the opened position and that the equipment increased the
air velocity towards the front of the cabinet. Smoke was not observed escaping the cabinet
however.
BioProtect IV with BD Influx Flow Cytometer
Gatehouse Rd., Sanford, Maine 04073 USA  (207) 324-8773  1-800-992-2537  FAX (207) 324-2632
Internet address: http// www.bakerco.com
Page 1 of 11
THE BAKER COMPANY
I. NSF/ANSI Standard 49 Microbiological Testing

Purpose:
The following standardized tests were conducted to evaluate the biosafety cabinet performance
with the Influx flow cytometer installed. The following tests were performed with the cytometer
in an operational condition.
Method:
All tests are performed to the NSF/ANSI Biosafety Standard 49- 2011. These tests determine
whether aerosols will be contained within the cabinet, outside contaminants will not enter the
cabinet work area, and aerosol contamination of other equipment in the cabinet will be
minimized. The cabinet shall be turned on at least 30 min before the start of any microbiological
test and operated continuously throughout all test procedures. The microbiological testing shall
demonstrate passing results at an operating range of plus or minus 10 fpm from nominal set point
as referenced in NSF/ANSI Standard 49 for Biosafety Cabinetry.
NSF Personnel Protection Test
Method:
The cabinet was challenged with Bacillus Subtilis bacterial spores at 8.0 X 10^8
spores/ml for each test run. Each test was run for a total of 30 min with a 15 min nebulizer
challenge. NSF requires the nebulizer to run for 5 minutes, Baker Company performs the testing
at a more stringent 15 minute nebulizer challenge. No more than 10 colony forming units total
shall be counted for each test on the filter from six AGI impingers for passing results, as per the
NSF standard and no more than 5 colony forming units shall be counted on both slit sampler agar
settling plates for passing results.
Acceptance:
The number of Bacillus subtilis spores (culture forming units) recovered from the 6 AGI
samplers shall not exceed 10 CFU per test. Total slit-type air sampler plate counts shall not
exceed 5 subtilis CFUs for a 30 min sampling period. The control plate shall be positive. A plate
is “positive” when it contains greater than 300 CFU of B. subtilis.
Page 2 of 11
THE BAKER COMPANY
Personnel Protection Test set up with nebulizer spore challenge at NSF-49 location
Containment results:
All Personnel Protection challenge tests were performed with the more stringent application of
the sort chamber door in the open or up position and the Aerosol Management system (AMO)
completely off. The assessment was to challenge the system with the worst condition in a static
state.
Air flow balance set points: NSF‐49 Required Performance Zone

Test 1 (52 fpm down flow , 106 fpm Intake)
CFU COUNT CFU COUNT
Control Air slit samplers 6‐AGI samplers Results
Positive 0 0 PASS

Page 3 of 11
THE BAKER COMPANY
CFU COUNT CFU COUNT
Positive 1 2 PASS

CFU COUNT CFU COUNT
Positive 0 0 PASS

CFU COUNT CFU COUNT
Positive 1 1 PASS
All required NSF/ANSI Standard-49, 2011 Personnel Protection Microbiological tests had
Passing results.
NSF Product Protection Test:

Method:
The cabinet was challenged with Bacillus Subtilis spores at 8.0 X 10^6 spores/ml for each
test run. Each test was run for a total of 30 min with a 15 min nebulizer challenge. NSF requires
the nebulizer to run for 5 minutes, Baker Company performs the testing at a more stringent 15
minute nebulizer challenge. No more than 5 colony forming units total on all settling plates
shall be counted for each test for passing results, as per the NSF standard.
Acceptance:
The number of Bacillus subtilis spores (culture forming units) on agar settling plates shall
not exceed 5 CFU for each test. The control plate shall be positive. A plate is “positive” when it
contains greater than 300 CFU of B.subtilis.
Page 4 of 11
THE BAKER COMPANY
Product Protection results:

All Product Protection challenge tests were performed with the more stringent application of the
sort chamber door in the open or up position and the Aerosol Management system (AMO)
operating in the high setting mode. The assessment was to challenge the system with the worst
condition in a static state.
Air flow balance set
points: NSF‐49 Required Performance Zone


Control CFU COUNT Results
Positive 2 PASS


Positive 0 PASS


Positive 1 PASS


Positive 1 PASS
All required NSF/ANSI-49, 2011 Product Protection Microbiological tests had Passing results
Page 5 of 11
THE BAKER COMPANY
Page 6 of 11
THE BAKER COMPANY
Note: All Product Protection tests had 150mm agar settling Petri dishes placed at the bottom of
the sort chamber and at the level of the waste collector as shown. No spores or culture forming
units were detected in any of the testing. Plates were clean of any contamination.
Nebulizer placed in required NSF-49 location
Alternative Sort Chamber Testing
Another condition of testing was performed at the sort/stream chamber only. Agar sampling
plates placed inside the chamber for product protection with AMO system on high setting and
the nebulizer placed inside the chamber for personnel protection with AMO system none
operational which was identified as the most extreme conditions for safety with sort chamber
door in the opened position.
Page 7 of 11
THE BAKER COMPANY
Personnel Protection testing with Nebulizer challenge inside sort chamber
Personnel Protection Testing: sort chamber door open
Test 1 (52 fpm down flow , 106 fpm Intake) AMO SYSTEM OFF

CFU COUNT CFU COUNT
Positive 0 8 PASS

Test 2 (52 fpm down flow , 106 fpm Intake) AMO OPERATING ON HIGH SETTING
CFU COUNT CFU COUNT
Positive 1 0 PASS
Page 8 of 11
THE BAKER COMPANY
Personnel Protection testing with Nebulizer callenge in the NSF-49 position
Personnel Protection Testing:

Test 3 (52 fpm down flow , 106 fpm Intake) AMO SYSTEM OFF
CFU COUNT CFU COUNT
Positive 3 1 PASS

Test 4 (52 fpm down flow , 106 fpm Intake) AMO OPERATING ON HIGH SETTING
CFU COUNT CFU COUNT
Positive 1 1 PASS
Page 9 of 11
THE BAKER COMPANY
Product Protection testing with door open and AMO system on high setting
Product Protection Testing:
AMO Operating on high setting‐sort door open
Positive 3 PASS

Test 2 (52 fpm down flow , 106fpm Intake)
AMO SYSTEM OFF ‐ SORT DOOR OPEN
Positive 3 PASS

AMO SYSTEM OFF ‐ SORT DOOR CLOSED

Positive 0 PASS
All sort chamber testing had Passing results.
Page 10 of 11
THE BAKER COMPANY
Conclusion:
The above test results provided evidence that the Baker Company BioProtect IV Cabinet with the
BD Influx flow cytometer passed the required NSF/ANSI Standard-49 biosafety standards. The
cabinet proved safe in every condition of challenge during standard operational conditions of the
cytometer. The opened door to the sort/stream chamber and challenge cylinder in place showed
that safety was not compromised during daily end user functions.
Worker Comfort Testing

Noise level Test
The noise level at nominal set point was 63.0db with a background of 53 db with the cytometer
operating inside the cabinet. BioProtect Cabinet operating only 62.4db
Acceptance: Overall noise level in front of the cabinet shall not exceed 67 db when
measured where the ambient sound level is 57db. Measurement on the “A” weighing scale.
Microbiological Testing
Robert A Thibeault
Page 11 of 11

BD Biosafety Influx BioProtect Report

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

BD Biosafety Influx BioProtect Report

Uploaded by

Copyright:

Available Formats

THE BAKER COMPANY

161 Gatehouse Rd., Sanford, Maine 04073 USA

Microbiological Testing Report 3/14/12

I. NSF/ANSI Standard 49 Microbiological Testing

NSF Personnel Protection Test

NSF Product Protection Test:

Product Protection results:

Nebulizer placed in required NSF-49 location

Alternative Sort Chamber Testing

Personnel Protection testing with Nebulizer challenge inside sort chamber

Personnel Protection Testing: sort chamber door open

Test 1 (52 fpm down flow , 106 fpm Intake) AMO SYSTEM OFF

Personnel Protection testing with Nebulizer callenge in the NSF-49 position

Personnel Protection Testing:

Product Protection Testing:

All sort chamber testing had Passing results.

Worker Comfort Testing

You might also like