Title: Coupons Effective Date: 7-15-93

DCR No.: 03023
Revision No.: 1

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

1

Purpose

1.1 To establish a procedure for removing and installing Supply and Exhaust
HEPA filters in Biohazard Class II Cabinets.

2 Scope

2.1 This procedure applies to Class II Biohazard Cabinets.

3 Reference

3.1 Biohazard Cabinet Manufacturer’s manual.

4 Definition

4.1 HEPA: High Efficiency Particulate Air
4.2 SOP: Standard Operating Procedure

5 Responsibility

5.1 Test and Balance (TAB) technicians shall record Filter Dimensions on
Form FN 8.057.4 (Biohazard Safety Cabinet Test Report Details III) in the
Filter Replacement Data section.

5.2 TAB technicians shall indicate the downflow, exhaust or both under HEPA
Filter Changeout section have been performed, Yes or No, on Form FN
8.057.1 (Biohazard Safety Cabinet Test Report Summary Sheet).

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

6 Materials Requirement

6.1 New HEPA filter
6.2 Silicone grease
6.3 Handtools of sizes specified by Biohazard Cabinet manufacturer

7

Test Equipment

7.1 None

8

Procedures

8.1 Decontaminate the Biohazard Cabinet using SOP 8.054 (Microbiological
Decontamination Procedure).

8.2 Follow Biohazard Cabinet manufacturer instructions for removing and
installing the HEPA filters.

8.3 Indicate that downflow, exhaust or both under HEPA Filter Changeout
section have been performed, Yes or No, on Form FN 8.057.1 (Biohazard
Safety Cabinet Test Report Summary Sheet).

8.4 Upon completion of HEPA filter changeout, perform HEPA filter leak test
as per SOP 8.050 (Biohazard Class II Cabinet HEPA Filter Leak Test).

9

Review and Approval

9.1 TAB technicians shall return the Form FN 8.057.4 (Biohazard Safety
Cabinet Test Report Details III) and the Form FN 8.057.1 (Biohazard
Safety Cabinet Test Report Summary Sheet) to the TAB Department for
review.

Document Approval

Test & Balance Supervisor
Engineering Manager
10/01
03
Date
Quality Assurance Manager
11-15
3
Date