ANNEXURE –2

Report No.
Ref. Protocol No.
Validation Report / Page No. / 1 of 3
Protocol Name: CONTAINER CLOSURE INTEGRITY PROTOCOL (MICROBIAL LEAK TEST)

1.0REPORT APPROVAL

Validation study is verified that all test cases required by the protocol are completed, reconciled and included in the Validation summary report.

Signatures in the block below indicate that all items in this Validation Report have been reviewed and found to be acceptable.

Department / Name /

Designation

/ Signature /Date

Prepared by

Quality Control
Microbiology

Checked by

Quality Control
Microbiology

Approved by

Quality Assurance

Authorised by

HOD - QA

2.0SUMMARY REPORT

Data generated duringValidation is reviewed and found complies with the acceptance criteria as per the protocol.

Date of Validation started
Date of Validation completed

2.1Activity:

With reference to protocol the container closure integrity test for 5,10, 20 ml glass vials performed along with Media fill validation as follows:

2.1.130 no of 10ml SCDM media filled vials are sealed with established crimping station height and transferred to microbiology lab.

2.1.224 No.s of media filled vials( i.e. 3 vials from each 8 crimping stations) ) are subjected for container closure integrity (With out opening Flip-off seal because the media is filled before sealing ) submerging in to the chamber of Leak Test Apparatus containing106-107 cfu/ml of Proteus vulgaris inoculated media and vacuum is applied for 3 minutes at 15 inches Hg. followed by contact period of one hour was given.

2.1.3For Positive control vials (6 Nos.) 10 -100cfu of cultures of C.albicans, A.niger and B.subtilis, one bacterial and one fungal isolates (xxxxxxxxxx) & Proteus vulgaris is injected with the help of sterile syringe..

2.1.4The above vials (24) are incubated along with negative control vials (4) at 30-35oC for 7 days in inverted position and another 7 days up right position and the positive control vials (5no.s) shall be incubated at 30-35 ºC for 3 days for bacteria and 5 days in case of fungi.

2.2Observation:

2.2.1The incubated test 10ml vials and negative control vials are checked on daily basis for 14 days and observed as No Growth.

2.2.2The positive control vials observed growth, which demonstrates the growth supporting of media.

Checks / Observations (Yes/No) / Reviewed By
Sign/ Date
All test procedures executed and verified as per the protocol.
All acceptance criteria set forth in the Validation were met
Deviation if any

3.0CONCLUSION

The container closure system for 5,10,20 ml vial sizes maintained the integrity of its microbiological barrier and the established crimping station heights are acceptable.

The container closure integrity test of 5,10,20 ml vial sizes is acceptable and sealing strength found to be satisfactory.

Authorized By

HOD - QA

Format No.: