SOP on container closure integrity for Dry powder for injection
Objective : To lay down the procedure for container closure integrity for Dry powder for injection.
Scope: This SOP is applicable for container closure integrity for Dry powder for injection.
Responsibility:
Officer or above of Microbiology Laboratory.
Head – Microbiology section.
Accountability: Head – Quality Control.
Procedure:
Chemical Method
Dye ingress method (Dye Solution Out side the Vials)
Prepare 3 liter of 5.0% Methyl blue dye solution in a S.S. vessel.
Fill 3 liter dye solution in vacuum leak test apparatus.
Submerge seven intact vials having dry powder for injection into the dye solution.
Operate the Vacuum leak test apparatus as per SOP on operation of vacuum leak test apparatus. Apply and hold the vacuum of 15 inches of Hg for 3 minutes.
Keep the vials submerged in the dye solution for additional 5 minutes to equilibrate with the outside pressure (Assuming there is leak through container closure system).
Negative control shall be unchallenged vials.
Individual vial shall be checked for the presence of dye which is illuminated against dark background.
The dye solution should not penetrate through the intact vials when observed visually against illuminated dark back ground for the presence of dye content and compared with unchallenged vial
The recording shall be done.
By Microbiology Challenge studies:
Enter into MLT room as per SOP.
Preparation of coli culture suspension of 106 Cfu/ml as per SOP.
Immerse 20 intact dry powder for injection vials in a container containing coli (ATCC 8739) approx. 106 Cfu/0.1ml for four hours.
Removed the vials after immersion for four hours, disinfected with 70 % IPA.
Enter into sterility test room as per SOP.
Collect the sample from the pass box after disinfection.
Perform the test as per GTP.
Negative control shall be unchallenged vial.
Remove the canisters from the drain tray and then incubate the canisters at 30°C -35°C for 72 hours.
The observation for any type of growth shall be recorded.
If the growth is observed it would indicate a failure of closure integrity.
There should be no growth after incubation at 30°C -35°C for 72 hours
The recording shall be done.
