Title: Coupons Effective Date: 7-15-93

DCR No.: 03019
Revision No.: 1

Effective: 3-5-99
Supersedes: 3-5-99
Revision Date: 11-15-03
Page No.: 1 of 4

1

Purpose

1.1 To establish a standard procedure to determine the integrity of supply and
exhaust HEPA filters, filter housings, and filter mounting frames of Class
II Biohazard Cabinets.

2 Scope

2.1 This procedure applies to Class II Biohazard Cabinets.

3 Reference

3.1 NSF Standard 49, 2002.

4 Definition

4.1 HEPA: High Efficiency Particulate Air
4.2 CFM: Cubic Feet per Minute
4.3 PSIG: Pounds per Square Inch Gauge

5 Responsibility

5.1 Test and Balance (TAB) technicians shall record all test measurements
on Form FN 8.057.3 (Biohazard Safety Cabinet Test Report Details II) in
the HEPA Filter Leak Test section and indicate the test results, Pass or
Fail, on Form FN 8.057.1 (Biohazard Safety Cabinet Test Report
Summary Sheet).

5.2 All test reports shall be saved in files, located in the TAB department of
Therma.

5.3 All test equipment utilized shall be in calibration in accordance with
National Environmental Balancing Bureau (NEBB) Standards and
traceable to the National Institute of Standards and Technology (NIST).

6

7 Materials Requirement

6.1 Dioctylphthalate (DOP) or
6.2 Poly-alpha olefin (Emery 3004) or
6.3 Polystyrene Latex Sphere (PSL)
6.4 Ringstand and Clamp

8 Test Equipment

7.1 Source of 20 PSIG
7.2 Total Scattering Aerosol Photometer and Hand Held Probe that meet the
criteria in NSF 49, Annex F, Section F.5, Subsection F.5.2
7.3 Aerosol Generator that meets the criteria in NSF 49, Annex F, Section
F.5, Subsection F.5.2
7.4 A pressure gauge for the generator having a maximum range of 0 to 80
PSI with resolution and accuracy of 1 PSI.

9 Procedures

8.1 Prior to performing the following tasks, verify the appropriate HEPA filter
challenge agent (e.g. DOP, PAO or others) that can be used in the
customer’s facility.

8.2 Calculate the HEPA filter challenge concentration. Record HEPA
challenge concentration on the Form FN 8.057.3 (Biological Safety
Cabinet Test Report Detail II).

Concentration of the challenge, when 20 PSIG is available at the Laskin
Nozzle Generator using DOP, can be calculated by using the following
formula:

Concentration in µg/l = 13,500(#Laskin Nozzles ÷ CFM)

8.3 Refer to NSF 49, Annex F, Section F.5.3, Subsection F.5.3.1
and F.5.3.2 for procedure.

8.4 Refer to NSF 49, Annex F, Section F.5.4 for standards of acceptance.

8.5 TAB technicians shall indicate Pass or Fail for the HEPA filter leak test,
on Form FN 8.057.1 (Biohazard Safety Cabinet Test Report Summary
Sheet).

Document Approval

Test and Balance Supervisor
Date

Engineering Manager
Quality Assurance Manager

11-15-03
Date