SOP for Environmental Monitoring of Manufacturing Area by Settling Plate Count : Pharmaceutical Guidelines

SOP for Environmental Monitoring of Manufacturing Area by Settling Plate Count

Standard operating procedure to ensure the control over viable count of different areas of manufacturing department of solid dosage forms.

1.0 Objective

To ensure the control over the viable count of manufacturing department of solid dosage forms..

2.0 Scope

This procedure is applicable for different part of all manufacturing area of solid dosage forms.

3.0 Responsibility

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

4.0 Accountability

Head of the Department

5.0 Procedure

5.1 Frequency of the test :

Once in a fortnight.
5.2 Location chart along with flow sheet diagram for settling plate in the area.

5.3 Preparation of plates

5.3.1 Pour about 20 ml of sterile soybean casein digest agar medium and Potato dextrose agar medium in each pre-sterilized and dried plate (90 mm size) under laminar air flow bench and allow it to Solidify.
5.3.2 After solidification of the medium, Pre - incubated the SCDA and PDA Petri plates at 30-35oC in inverted position in stainless steel trays for 48 hours.
5.3.3 After the incubation period, observe the plates for contamination.
5.3.4 Discard contaminated plates as per S.O.P., if any found.

5.4 Procedure for Exposing plates:

5.4.1 Mop the stainless steel trays along with lid using 70% filtered Isopropyl alcohol (I.P.A) Solution and arrange the plates after proper marking, indicating location and date of exposure.
5.4.2 Transfer the trays to tablet and capsule manufacturing area through the material entry.
5.4.3 Expose both PDA and SCDA Petri plates placing in the right receptacle as per location chart.
5.4.4 Expose PDA and SCDA plate in each location on the floor.
5.4.5 Mark exposure time on each Petri plate label.
5.4.6 Expose the plate for two (2) hours at a location near/below the return air supply duct.

5.5 Procedure for incubation

5.5.1 Incubate SCDA plates in inverted position together with control Petri plates ( unexposed) at 30-35oC temperature for 72 hrs.
5.5.2 Incubate PDA plates in inverted position together with control Petri plates ( unexposed) at 20-25oC temperature for 5days.
5.5.3 After 72 hrs. count the bacterial colony in SCDA plates, identify the bacteria with the help of colonial characteristics and morphological characteristics.
5.5.4 After five days, count the fungal colony in PDA plates and Identify the fungi with the help of colonial characteristics and morphological characteristics.
5.5.5 Record the results in Annexure.

5.6 Limit: cfu/Plate

Area                              Alert level                 Action level
Solid dosage area              50                              >70

5.7 ACCEPTANCE CRITERIA:

The bacterial colony should be within the limit and fungal colony should be absent.

6.0 Abbreviations

6.1 cfu= Colony forming unit
6.2 oC = Degree centigrade
6.3 LAF= Laminar Air flow
6.4 I.P.A= Isopropyl alcohol
6.5 % = Percentage
6.6 hrs.= Hours
6.7 mfg.= Manufacturing
6.8 PDA= Potato Dextrose Agar
6.9 SCDA = Soybean casein digest agar
6.10 S.S = Stainless steel

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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. What is the BP chapter no of environment monitoring.

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  2. How to decide sampling locations in clean rooms. Iso8 & Iso7

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