SOP for Recovery Test Procedure

Prepared by： X X
Department Name Date

Approve by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date

1. Purpose
The purpose is to determine the capabilities of the system to recover from internally
generated contamination
2. Scope
 This procedure is applicable to – HEPA filter Utilities in Humanwell Pharmaceutical
Ethiopia PLC

3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

The Utility division & the quality assurance manager are responsible for SOP compliance.

5. Material and Equipment

 Visual smoke generator

 Particle counter

6. Procedure
6.1. Generate smoke for 1 to 2 minutes and shut off the smoke tube at a predesignated
location.
6.2. After 2 minutes, advance the sample tube of the particle counter to a point directly
under the smoke source and at the level of the work zone. Record the particle count.
If it is not 100/ft3 or less, repeat the test with the wait interval increased in steps of
1/2 minute until counts are less than 100 ft3.
6.3. Repeat for all grid areas, recording recovery time for each grid area.
6.4. Acceptance Criteria
6.5. The recovery time should be not more than 2 minutes or as specified for
individual work zone in the validation master plan.
7. Abbreviations
 SOP - Standard Operating Procedure
 HEPA-High Efficiency Particulate Air

8. Related Documents /Applicable document/

Related Documents./ Title

SOP/UL/011/F01
Recovery Test Procedure Recording Form
9. Revision History

Version
Revision Description
No.

1 New