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:
N/A
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:-
Monthly
9. Records:-
Sterility
testing of Empty vials/ Ampoules/ Rubber Stoppers after Sterilization
10. References:-
11. Distribution:-
This SOP has to be distributed in below mentioned
Departments:-
|
Sr. NO
|
Distributed to
|
Received
(Current)
|
Returned
(Obsolete)
|
|
1
|
Quality Control Department
|
|
|
|
2
|
Quality Management
Department
|
|
|
12.
Revision History:-
Date Changes
N/A