SOP for Identification of Contaminant in Sterile Area : Pharmaceutical Guidelines

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SOP for Identification of Contaminant in Sterile Area

Standard operating procedure to identify the contaminants present in sample analysed during environmental monitoring.

1.0 Objective

To correlate the identification of contaminant during environmental monitoring of sterile area Inoculation room and a positive sample of sterility test.

2.0 Scope

This procedure is applicable to identify the contaminants present in the sample analyzed during environmental monitoring.

3.0 Responsibility

3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive /Manager

4.0 Accountability

Head of the Department

5.0 Procedure

Frequency: Weekly
5.1 Expose the plate as per S.O.P.
5.2 Transfer the microbial growth of contaminants from plate to SCD slant with the help of sterile nichrome wire loop.
5.3 Incubate it at 30 -35oC for 48 hrs.
5.4 Study the characteristics of colony observed.
5.5 After the incubation period, carry out gram staining on the slide as per S.O.P. and study morphology.
5.6 Record the observation of colony characters and morphology character as per Annexure-I
5.7 Discard the growth containing slant as per S.O.P.

6.0 Abbreviations

6.1 % =Percentage
6.2 hrs. = hours
6.3 SCD= Soybean Casein Digest
6.4 °C = Degree centigrade

ANNEXURE-1
MICROBIOLOGICAL LAB
IDENTIFICATION OF CONTAMINANTS REPORT

DATE
LOCATION
COLONY
CHARACTERS
MORPHOLOGY CHARACTER
SIGN
REMARKS





















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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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