Cleaning validation test request form for Multimill

Cleaning Validation Protocol for Multi mill

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1.0 OBJECTIVE: Cleaning Validation Protocol for Multi Mill is designed to ensure that the cleaning procedure for multi mill removes residues to the extent of compliance with pre-determined acceptance level.

2.0 SCOPE: This protocol applies to Pharmaceutical Manufacturing Facility.

3.0 RESPONSIBILITY: It is a joint responsibility of Quality Control, Production, and Quality Assurance departments. The detailed responsibility 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 Multi-mill

5.0 SAMPLING PLAN

  • First, wash with Raw Water, and then Sample from first rinse (sample-I).
  • For second sample, wash with 0.1% liquid soap solution and raw water, then sample from second rinse (sample-II).
  • Sample from final rinse of purified water after completion of the cleaning procedure (sample-III).
  • Swab (in 2.5 cm x 2.5 cm area) for chemical analysis (sample-IV).
  • Swab (in 10 cm x 10 cm area) for bio-burden (sample-V).

6.0 SAMPLING POINTS

  • Powder Feed Hopper
  • Blades
  • Screen
  • Powder discharge Hopper.

Please refer ANNEXURE – B

7.0 TEST / METHOD

  • Inspect visually for the absence of previous product in the equipment from (sample-I)
  • Determine the absence of detergents by froth method from (sample-II ).
  • Determine the concentration of active ingredient of the previous product in the final rinse from (sample III).
  • Determine the concentration of active ingredient of the previous product in the swab from (sample IV).
  • Report and record the above test (1,2,3 and 4) results in ANNEXURE – C
  • Determine the bio-burden from (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 i.e., (sample III)
  • Concentration of the previous product should not be more than 2 PPM in the swab (i.e., sample IV)
  • Bio-burden limits are as below (sample V)
    • Total CFU – NMT 10 CFU
    • E. Coli -absent
    • Salmonella – absent

9.0 ANNEXURE – A

Cleaning validation test request form for Multi mill

10.0 ANNEXURE – B

SCHEMATIC SKETCH OF SAMPLING POINTS of Multimill

11.0 ANNEXURE-C

Cleaning validation test Report for Multi mill

12.0 ANNEXURE-D

Cleaning validation test Report for Multi mill 2

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