Sterility assurance of sterilized ampoules, vials and rubber stoppers

1.     Purpose:-                         

                       To ensure the sterility of Sterilized ampoules, vials and rubber stoppers used as packaging components of Sterile Injectable Products.
2.     Scope:-

                  This procedure is applicable to Sterilized glass vials, glass ampoules and rubber stoppers.
3.     HSE Statement:-

                                Not Applicable.
4.     Responsibilities:-

                               i)      Manager Quality Control is responsible to ensure that procedure & formats are followed entirely as approved.
                             ii)      Officer Microbiologist is responsible to perform the test
5.     Materials:-

      5.1 Sterile Forceps for sampling purpose
5.2 Sterile 200ml Tryptic Soya Broth (TSB) in a screw capped flask
5.3 Sterile 250ml Conical Flask
     6. Definitions:

 7.Flow Chart:-

8. Description:-
8.1 Procedures:-            
8.1.1 Transfer the sterilized material into the aseptic process area via pass through.
8.1.2 Enter into aseptic area after sterile gowning.
8.1.3 With the help of the sterile forceps, take at least 10 units of sample from different sites and transfer
them into sterile empty 250ml conical flasks.
8.1.3  The Activity should be performed under Laminar Air Flow Hood.
8.1.4  Conduct the sterility test in microbiological lab under aseptic conditions.
8.1.5  Open the screw cap of labeled conical flasks containing sterile 100ml TSB and transfer the  appropriate amount of samples into the flasks.
8.1.6 Close the flask with screw cap tightly.
8.1.7 Incubate the samples at 22.5+ 2.50C   for 14 days.
8.1.8 Observe the presence or absence of any growth in TSB flasks and record the results.  
8.2. Frequency:-
9. Records:-
Sterility testing of Empty vials/ Ampoules/ Rubber Stoppers after Sterilization
10. References:-
United States Pharmacopeia 35
11. Distribution:-

This SOP has to be distributed in below mentioned Departments:-

Sr. NO
Distributed to
Quality Control Department

Quality Management Department

12. Revision History:-
Date                                        Changes