SOP For Recovery Test Procedure

This document provides the standard operating procedure for conducting a recovery test of the HEPA filter utilities system at Humanwell Pharmaceutical Ethiopia PLC. The test involves generating visual smoke in designated areas and using a particle counter to ensure particle counts drop below 100 particles per cubic foot within 2 minutes of shutting off the smoke, demonstrating the system's ability to recover from internally generated contamination. The utility division and quality assurance manager are responsible for compliance with this SOP.

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SOP For Recovery Test Procedure

Uploaded by

Solomon Gamanuel

Available Formats

Download as DOCX, PDF, TXT or read online on Scribd

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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