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.
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 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
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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