SOP for Check the Fertility Properties of the Procured Microbiological Media : Pharmaceutical Guidelines

SOP for Check the Fertility Properties of the Procured Microbiological Media

Standard operating procedure to ensure that microbiological media has fertility properties for microorganisms.

1.0 OBJECTIVE

To lay down the procedure to check the Fertility properties of the procured Media.

2.0 SCOPE

This SOP shall be applicable to the Quality Control Dept.

3.0 RESPONSIBILITY

Microbiologist.

4.0 ACCOUNTABILITY

Head Quality Control Department.

5.0 PROCEDURE

5.1 Liquid Broth Medium/Agar Medium (Fertility / Positive Control):
5.1.1 Prepare culture dilution as per SOP.
5.1.2 Inoculate 1 ml of culture to the sterile culture media and incubate at the recommended temperature specified for the organism.
5.1.3 The media complies the fertility test if luxuriant growth (turbidity) is observed in the inoculated tubes of liquid media or distinct colony formation on the agar media plate within 3 days for bacteria at 30-35°C and 5 days for fungi at 20-25° C incubation respectively. (Reference- USP-28 page no. 2252).
5.1.4 If the observations are without any microbial growth discard the batch of medium.
5.1.5 Observe inoculated media daily for any growth and note down the result in the format.

6.0 ABBREVIATIONS

USP: United State Pharmacopoeia
SOP: Standard Operating Procedure
QC: Quality Control
Dept.: Department





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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