Cleaning Validation Protocol for Pharmaceutical Equipments

The Cleaning Validation Protocol is an essential part to execute the cleaning validation process.

1.0 OBJECTIVE To assure that the cleaning procedure for Equipment removes residues to the extent of compliance with the pre-determined acceptance level. (Sifter As an Example)

2.0 SCOPE: This protocol applies to the Pharmaceutical Manufacturing Facility.

3.0 RESPONSIBILITY: It is a joint responsibility of the 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 QA
• Test result view And approval- Manager QA
• Validation Data Compilation- Executive QA
• Validation final approval- Head QA

4.0 PROCEDURE    

Clean the equipment as per SOP “Cleaning of Equipment”.

Sample from the specified sampling points (6.0) as per the sampling plan (5.0).

5.0 SAMPLING PLAN

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

6.0 SAMPLING POINTS

1. Upper  Hopper
2. Sieve used for the batch
3. Powder discharge assembly

Note: Sampling points may differ from equipment to Equipment (We used Shifter for Reference)

7.0 TEST / METHOD

• Inspect visually for the absence of previous products in the equipment (sample I)
• Determine the absence of detergents by the 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 – B
• Determine the bio-burden(sample V) and record the results in ANNEXURE– C

8.0 ACCEPTANCE CRITERIA

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

Annexure- A (Cleaning Validation Test Request Form)

Annexure- B (Cleaning Validation Test Report)

Note: Attach calculation sheet and chromatogram.

Conclusion / Recommendations:

_______________________________________________________________________________________

Tested by: ______________                                                                     Approved by: ________________

                    (Analyst – QC)                                                                                                 (Manager – QC)

Date::                                                                                                       Date:

Annexure – C (Cleaning Validation Test Report)

Analyzed by:  _______________                                                                Approved by: ________________

             (Microbiologist)                                                                                       (Manager – QC)

Date:                                                                                                                                             Date: