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Questions and Answers List

Question	Answer
TEST FOR PARENTERALS (Sterile Products)	A. Sterility test B. Test for Pyrogens C. Safety Test D. Particulate Matter Test E. Leaker's Test
Sterility Test methods	1 Primary - membrane filtration 2 Direct transfer - direct inoculation 3 Biological indicators
Culture Media:	1 Soybean Casein Digest Medium 2 Fluid thioglycollate Medium
Culture media for 1 Anaerobic bacteria (20-25C) 2 Fungi and Aerobic Bacteria (30-35C)	1 Soybean Casein Digest Medium 2 Fluid thioglycollate Medium
Time of Incubation: 1 Membrane Filtration: __ 2 Direct inoculation: __ 3 Biological indicators: Incubation: __	. 1) 7 days 2) 7-14 days 3) 18-24 hours
is the regulatory method of choice for filterable pharmaceutical products. The test is particularly suitable for samples containing preservative, bacteriostatic or fungistatic compounds, which inhibit microbial growth of potential contaminants	Primary - membrane filtration
the test sample is added directly into the required media, ensuring that the amount of sample is below 10% of the total media volume	Direct transfer - direct inoculation
It is also known as spore tests, are the most accepted means of monitoring sterilization because they assess the sterilization process directly by killing known highly resistant microorganisms (e.g., Geobacillus or Bacillus species)	Biological indicators