SOP for Lyophilized Vials of Microorganisms : Pharmaceutical Guidelines

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SOP for Lyophilized Vials of Microorganisms

Standard operating procedure of handling of lyophilized vials of microorganisms in microbiology laboratory.

1.0 OBJECTIVE

To describe the procedure for the procedure for opening of lyophilized vials of microorganisms.

2.0 SCOPE

This SOP is applicable to the procedure for opening of lyophilized vials of microorganisms.

3.0 RESPONSIBILITY

Microbiologist - Quality Control

4.0 ACCOUNTABILITY

Manager –Quality Control

5.0 PROCEDURE

5.1 Prepare the required and specified media as per SOP (5 ml in 20 ml tube), for the growth of microorganisms.
5.2 Prepare the SCDA media plates and slopes as per SOP.
5.3 Wipe the Bio-safety cabinet work bench with disinfectant. Sterilize utensils like forceps, aluminium foil for culturing.
5.4 Collect all the sterile wares through pass box, remove all wrapping in Bio-safety cabinet.
5.5 Wipe the lyophile thoroughly with 70 % IPA v/v.
5.6 Scratch the surface of ampoule near the top with the sterile cutter.
5.7 Snap off the top.
5.8 Remove cotton with a pair of sterile forceps.
5.9 Discharge the cotton in empty sterile tube.
5.10 Transfer 1 ml sterile medium in the lyophilized powder. Suspend thoroughly on cyclo-mixture.
5.11 Streak a loop-full on agar plate as well as 0.5 ml in 5 ml medium tube. Retain remaining suspension in the refrigerator.
5.12 After specified incubation, incubate pure typical colony on a slant as per SOP.
5.13 Check colony morphology, as well as microscopic morphology after incubation of slant.
5.14 After confluent growth, preserve slant in the refrigerator (2 to 8°C).

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 SCDA - Soybean Casein Digest Agar
6.3 v/v - Volume/Volume
6.4 IPA - Isopropyl Alcohol
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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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  1. I want require IQ,OQ,PQ of Lyophilizer can you provide me.

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