Page 13 - Quality control of pharmaceuticals (07-PA 704) practical

V. STERILITY TESTING OF PHARMACEUTICALS

Aim: To carryout sterility testing of different pharmaceutical products

A) Definitions:

1. Sterility
Within the strictest definition of sterility, an article is deemed to sterile when there is complete
absence of viable microorganisms. Absolute sterility cannot be practically demonstrated because
it is technically unfeasible to prove a negative absolute.
2. Sterility test: A test that critically assesses whether a sterilized pharmaceutical product is free
from contaminating microorganisms.
3. Membrane Filtration Method
This procedure is applicable to all the sterile materials, which when in liquid form can pass
through the membrane filter of pore size of 0.45 um. For example, Eye drops, Ampoules, Powder
vials and sterile bulks.
4. Fluid Thioglycollate Medium (FTM):
FTM is primarily intended for the cultivation of anaerobic bacteria.
5. Soybean Casein Digest Broth (Tryptic Soy Broth) (TSB):
TSB is suitable for the culture of both fungi and aerobic bacteria.
6. Peptone Water:
Water-soluble digests or hydrolysates of proteins that are used in the preparation of culture
media. Peptone water is used as diluting and rinsing fluid in sterility testing.
7. Negative Control: - To verify testing conditions a negative control is performed using the
chosen diluents in place of test preparation. There must be no growth of microorganisms.

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