Title: Coupons Effective Date: 7-15-93

DCR No.: 03025

Effective: 3-5-99

Supersedes: 3-5-99

Revision No.: 1

Revision Date: 11-15-03

Page No.: 1 of 6

1

Purpose

1.1 To ensure the correct and accurate completion of the Biohazard Safety Cabinet Test Report Summary Sheet.

2 Scope

2.1 This procedure applies to Class II Biohazard Cabinets.

3

Reference

3.1 SOP 8.024 (Biohazard Class II Cabinet Electrical Test)

3.2 SOP 8.047 (Biohazard Class II Cabinet Downflow Velocity Test)

3.3 SOP 8.048 (Biohazard Class II Cabinet Inflow Velocity Tests)

3.4 SOP 8.049 (Biohazard Class II Cabinet Airflow Smoke Patterns)

3.5 SOP 8.050 (Biohazard Class II Cabinet HEPA Filter Leak Test)

3.6 SOP 8.051 (Biohazard Class II Cabinet Lighting Intensity Test)

3.7 SOP 8.052 (Biohazard Class II Noise Level Test)

3.8 SOP 8.053 (Biohazard Class II Cabinet Vibration Test)

3.9 SOP 8.054 (Microbiological Decontamination Procedure)

3.10 SOP 8.055 (Biohazard Class II Cabinet HEPA Changout)

3.11 SOP 8.056 (Biohazard Class II Cabinet Leak Test)

3.12 SOP 8.058 (Biohazard Class II Cabinet Site Installation Assessment Tests)

3.13 NSF Standard 49, 2002

4

Definition

4.1 None

5

Responsibility

5.1 Test and Balance (TAB) technicians shall record all test measurements on Form FN 8.057.2, FN 8.057.3, and FN 8.057.4 (Biohazard Safety Cabinet Test Report Details I, II, & III) and indicate results 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 Materials Requirement

6.1 None

7 Test Equipment

7.1 None

8 Procedures

8.1 Downflow Velocity Test

8.1.1 Refer to SOP 8.047 for procedure and standards for acceptance.

8.1.2 If test results meet the standards for acceptance, check the "Pass" checkbox. If they do not meet the standards for acceptance, check the "Fail" checkbox.

8.1.3 Write a note of explanation of why the Biohazard Cabinet failed the test and a recommendation of how the cabinet could be brought into compliance with NSF 49.

8.2 Inflow Velocity Test

8.2.1 Refer to SOP 8.048 for procedure and standards for acceptance.

8.2.2 If test results meet the standards for acceptance, check the "Pass" checkbox. If they do not meet the standards for acceptance, check the "Fail" checkbox.

8.2.3 Write a note of explanation of why the Biohazard Cabinet failed the test and a recommendation of how the cabinet could be brought into compliance with NSF 49.

8.3 Airflow Smoke Patterns

8.3.1 Refer to SOP 8.049 for procedure and standards for acceptance.

8.3.2 If test results meet the standards for acceptance, check the "Pass" checkbox. If they do not meet the standards for acceptance, check the "Fail" checkbox.

8.3.3 Write a note of explanation of why the Biohazard Cabinet failed the test(s) and a recommendation of how the cabinet could be brought into compliance with NSF 49.

8.4 HEPA Filter Leak Test

8.4.1 Refer to SOP 8.050 for procedure and standards for acceptance.

8.4.2 If test results meet the standards for acceptance, check the "Pass" checkbox. If they do not meet the standards for acceptance, check the "Fail" checkbox.

8.4.3 Write a note of explanation of why the Biohazard Cabinet failed the test and a recommendation of how the cabinet could be brought into compliance with NSF 49.

8.5 Electrical Tests

8.5.1 Refer to SOP 8.024 for procedure and standards for acceptance.

8.5.2 If test results meet the standards for acceptance, check the "Pass" checkbox. If they do not meet the standards for acceptance, check the "Fail" checkbox.

8.5.3 Write a note of explanation of why the Biohazard Cabinet failed the test and a recommendation of how the cabinet could be brought into compliance with NSF 49.

8.6 Lighting Intensity

8.6.1 Refer to SOP 8.051 for procedure and standards for acceptance.

8.6.2 If test results meet the standards for acceptance, check the "Pass" checkbox. If they do not meet the standards for acceptance, check the "Fail" checkbox.

8.6.3 Write a note of explanation of why the Biohazard Cabinet failed the test and a recommendation of how the cabinet could be brought into compliance with NSF 49.

8.7 Noise Level

8.7.1 Refer to SOP 8.052 for procedure and standards for acceptance.

8.7.2 If test results meet the standards for acceptance, check the "Pass" checkbox. If they do not meet the standards for acceptance, check the "Fail" checkbox.

8.7.3 Write a note of explanation of why the Biohazard Cabinet failed the test and a recommendation of how the cabinet could be brought into compliance with NSF 49.

8.8 Vibration

8.8.1 Refer to SOP 8.053 for procedure and standards for acceptance.

8.8.2 If test results meet the standards for acceptance, check the "Pass" checkbox. If they do not meet the standards for acceptance, check the "Fail" checkbox.

8.8.3 Write a note of explanation of why the Biohazard Cabinet failed the test and a recommendation of how the cabinet could be brought into compliance with NSF 49.

8.9 HEPA Filter Changeout

8.9.1 If the supply or exhaust HEPA filter in the Biohazard Cabinet does not pass the HEPA Filter Leak Test, and the leak cannot be repaired, the HEPA will need to be replaced. Check the "Yes" checkbox in the "Additional Biohazard Safety Cabinet System Services" section.

8.9.2 Refer to SOP 8.055 for HEPA Filter Changeout procedure.

8.10 Bag In / Bag Out Filter Change

8.10.1 If the Bag In / Bag Out Filter does not pass the HEPA Filter Leak Test and cannot be repaired, or if the Bag In / Bag Out Filter is loaded, it will need to be replaced. Check the "Yes" checkbox in the "Additional Biohazard Safety Cabinet System Services" section.

8.10.2 Refer to SOP for Bag In / Bag Out Filter Change procedure.

8.11 Decontamination

8.11.1 If the interior of the Biohazard Safety Cabinet must be accessed for any reason, the Cabinet must be decontaminated.

8.11.2 Refer to SOP 8.054 for decontamination procedure

8.12 Cabinet Leak Test

8.12.1 All Class 2, type A1 Biohazard Cabinets must be leak tested when newly installed, moved or after the panels are removed to access the interior.

8.12.2 Refer to SOP 8.056 for procedure and standards of acceptance.

8.13 Site Installation Assessment Tests

8.13.1 Refer to SOP 8.058 for procedure and standards for acceptance.

8.13.2 If test results meet the standards for acceptance, check the "Pass" checkbox. If they do not meet the standards for acceptance, check the "Fail" checkbox.

8.13.3 Write a note of explanation of why the Biohazard Cabinet failed the test(s) and a recommendation of how the cabinet could be brought into compliance with NSF 49.

8.14 Final Testing Results

8.14.1 If the Biohazard Cabinet passes all of the annual certification tests, check the "Yes" checkbox at the top of the form in the "This Unit is Certified to NSF/ANSI 49-2002, Annex F" row. If it does not pass every test, check the "No" checkbox, and note the deficiencies necessary to bring the cabinet into compliance with NSF 49.

9

Review and Approval

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

Document Approval

Test & Balance Supervisor

Date

Engineering Manager

Quality Assurance Manager

11-15-03

Date