Page 15 - Quality control of pharmaceuticals (07-PA 704) practical

5. Connect the filtration assembly to filtrate collection flask as well as to vacuum pump. The
collecting vessel along with the tubing is steam sterilized for 30 minutes, properly rapped in
aluminum foil.

6. Unscrew the flask containing prepared sample. Flame the lip of the flask and pour the entire
contents into the filtration funnel without dripping the sample down the side of the flask.

7. Filter the sample by using vacuum pump.
8. Rinse the filter once with 200 ml of sterile peptone water.
9. Filter 200 ml of peptone water containing same quantity of pencillinase as used in case of test

sample and treat it as negative control.
10. Remove the valve on each filter system after each filtration and at the end of the entire

procedure.
11. Open the caps of media flasks as FTM & Soyabean Casein Digest Medium / TSB and heat

their lips properly.
12. Remove the filter funnel and pick the filter using a sterile flat tipped forceps, from the base of

the filter holder.
13. Cut the filter in to two equal halves with the help of sterile scissors and dip one piece

in FTM and one piece in Soyabean Casein Digest Medium / TSB.

D) Interpretation of Sterility Test Results
During incubation period observe the test media flasks daily for the evidence of turbidity due to
any microbial growth. Product is sterile if no evidence of growth is found throughout the
incubation period. When microbial growth is observed and confirmed microscopically, the article
does not meet the requirements of the sterility test. However, if the microbial growth can be
without a doubt ascribed to faulty aseptic techniques or materials used in conducting the sterility
testing procedure, the test is invalid and must be repeated. Repeat the test on same number of units
as already tested in previous test.

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