SOP for Identification of Contaminant in Sterile Area : Pharmaceutical Guidelines

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 positive sample of sterility test.

2.0  SCOPE

       This procedure is applicable to identify the contaminants present in sample analysed 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 incubation period ,carry out gram staining on slide as per S.O.P. and study the 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= Soyabean Casein Digest
6.4  oC = Degree centigrade


ANNEXURE-1
MICROBIOLOGICAL LAB.
IDENTIFICATION  OF CONTAMINANTS REPORT
DATE
LOCATION
COLONY
CHARACTERS
MORPHOLOGY CHARACTER
SIGN
REMARKS


























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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