October 01, 2021: Pharmaceutical Interview Questions and Answers

#TotalViableAerobicCount #BioburdenTestMethodValidation

1. What is Total viable aerobic count?

Total viable aerobic count is designed to count the number of microorganisms (as colony forming units, CFUs) in a non-sterile pharmaceutical product or raw materials.

It is father divided into two parts, total aerobic microbial count (TAMC) and total yeast and mould counts (TYMCs).

2. Which are the methods used for analysis of total viable aerobic count?

● Membrane filtration technique – Sample is filtered and the filter is placed on defined media

● Pour plate technique – Sample aliquot is taken and placed in a Petri dish and specified media poured onto the sample

● Spread plate technique – Sample aliquot is placed on the surface of defined media and smeared evenly over the surface

● Most probable number (MPN) technique – This method is used for mainly insoluble materials. The sample dilutions are placed into a series of replicate tubes and the number of tubes showing growth give a statistical evaluation of the number of microorganisms in the sample.

3. Which is Bioburden test Method Validation?

The Bioburden Method Validation is done to demonstrate the adequacy of sample preparation method and the ability of the media to recover microorganisms in the presence of the test sample. Following should be considered during the method validation.

(a) Growth promotion of media

(b) Sample preparation