Cleaning Validation Protocol for Sifter

1.0 OBJECTIVE: Cleaning Validation Protocol for Sifter to ensure that the cleaning procedure for Sifter removes residues to the extent of compliance with pre-determined acceptance level.

2.0 SCOPE: This protocol applies to Pharmaceutical Manufacturing Facility (name of company and place)

3.0 RESPONSIBILITY: It is a joint responsibility of Quality Control, Production and Quality Assurance departments. The detailed responsibility matrix is given below:

• Protocol Preparation – Executive QA
• Protocol Approval – Head – QA
• Protocol Execution – Head – Production
• Sampling as per Protocol – Executive – QA
• Testing as per Protocol – Executive – QC
• Test Results Review and Approval – Manager – QC
• Validation Data Compilation – Executive – QA
• Validation Final Approval – Head – QA

4.0 PROCEDURE: for Cleaning Validation Protocol for Sifter

• Clean the equipment as per SOP (Title: Procedure for cleaning of Sifter).
• Sample from the specified sampling points (6.0) as per the sampling plan (5.0).

5.0 SAMPLING PLAN

• Sample from first rinse (after washing with raw water).
• Sample from second rinse (after cleaning with 0.1% liquid soap solution and raw water).
• Sample from final rinse of purified water.
• Swab (in 2.5 cm x 2.5 cm area) for chemical analysis.
• Swab (in 10 cm x 10 cm area) for bio-burden.

6.0 SAMPLING POINTS

• Upper Hopper
• Sieve used for the batch
• Powder discharge assembly

Note: Please refer to ANNEXURE – B

7.0 TEST / METHOD

• Inspect visually for the absence of previous product in the equipment (sample I).
• Determine the absence of detergents by froth method (sample II).
• Determine the concentration of active ingredient of the previous product in the final rinse (sample III).
• Determine the concentration of active ingredient of the previous product in the swab (sample IV).
• Report and record the above test (1,2,3 and 4) results in ANNEXURE – C.
• Determine the bio-burden (sample V) and record the results in ANNEXURE – D.

8.0 ACCEPTANCE CRITERIA

• No traces of the powder shall be visible on any part of the machine (sample I).
• Detergent should not be identifiable by frothing test (sample II).
• Concentration of the previous product should not be more than 10 PPM in the final rinse (sample III).
• Concentration of the previous product should not be more than 2 PPM in the swab (sample IV).
• Bio-burden limits are as below (sample V):
  • Total CFU – NMT 10 CFU
  • E. Coli – absent
  • Salmonella – absent

9.0 ANNEXURE – A

10.0 ANNEXURE – B

SCHEMATIC SKETCH OF SAMPLING POINTS

11.0 ANNEXURE – C

12.0 ANNEXURE – D