SOP for Environmental Monitoring of Walk-in-Incubators : Pharmaceutical Guidelines

SOP for Environmental Monitoring of Walk-in-Incubators

Standard operating procedure to check viable count in walk-in-incubator.

1.0  Objective

       To ensure control over microbial count in walk-in-incubator.

2.0  SCOPE

       This procedure is applicable to check viable count in walk-in-incubator.

3.0  Responsibility

3.1  Doing      : Technical Assistant(Microbiologist)
3.2  Checking : Executive/Manager    

4.0  Accountability

       Head of the Department      

5.0  Procedure

5.1  Frequency : weekly

5.2  Prepare the Media as per S.O.P.      
5.3  Mop the  stands with filtered 70% IPA.
5.4  Expose the plate for four hours as per attached Location chart in both walk-in-incubator keeping on provided s..s. stand.
5.5  Observe the result and record it as per Annexure-I

5.6  Limit : Settling plate (cfu/plate)         



Area
Alert level
Action level
Walk-in-incubator
20-25°C
>7
>15
Walk-in-incubator
30-35°C

>7

>15

Acceptance criteria :-

Bacterial Colony should be within Limit and Fungal Colony should be  Absent

6.0  ABBREVIATIONS

6.1  cfu = Colony forming unit
6.2  °C =  Degree centrigrade
6.3  SOP=Standard operating procedure





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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