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

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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 centigrade
6.3 SOP=Standard operating procedure
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