SOP for Environmental Monitoring of Clean Area and LAF Modules : Pharmaceutical Guidelines

SOP for Environmental Monitoring of Clean Area and LAF Modules

Standard operating procedure to ensure control over viable and non viable count in clean area of Microbiology section.

1.0 Objective

To ensure control over viable and non-viable count in the clean area of Microbiology section.

2.0 Scope

The procedure is applicable to
- Sterility Testing area
- Inoculation room
- Cooling zone
- Airlocks I, II & III as well as LAF unit & sterile dress cabinet.
This procedure is also applicable to monitor the personal hygiene for personnel working in the clean area as a part of Environmental monitoring.

3.0 Responsibility

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

4.0 Accountability

Head of the Department

5.0 Procedure

5.1 Settling Plate Count

5.1.1 Air sampling for the viable count by slit –to-agar air sampler.
5.1.2 Surface testing by Rodac plate
5.1.3 Fingerprint & gown swab test.
5.1.4 Nonviable count (Air particulate matter)

5.2 SETTLING PLATE

5.2.1 Frequency:-Daily
Exposure Time:- 4 Hrs. [covering working activities]
5.2.2 Preparation of the medium as per SOP.
5.2.3 Expose both Petri plate in Sterility testing room, Inoculation room, Cooling zone, Airlocks, and at as per respective location chart.
5.2.4 Expose the plates with following media
[1] Soybean Casein Digest Agar:- For Bacteria
[2] Potato Dextrose Agar:- For fungi
5.2.5 Put the plate exposing detail.
5.2.6 Record the results.

5.3 Air sampling viable count by Slit- to-Agar Air Sampler.

5.3.1 Frequency Daily to cover each area once in a week.
5.3.2 Media preparation (SCD Agar) as per SOP.
5.3.3 Operate Slit-To-Agar air Sampler as per SOP during working activity.
5.3.4 Sampling point for air sampling in sterility testing room.
5.3.5 Record the results.

Related: Disinfectant Solutions and Their Mode of Action

5.4 Surface Testing By means of Rodac Plate.

5.4.1 Frequency once in a week.
5.4.2 Preparation of Sterile Rodac Plate as Per SOP.
5.4.3 Open the Rodac plate & contact them on sampling site after working activity as per Location chart.
5.4.4 After contact close the Rodac plate with lid & spray the 70% IPA as a disinfectant solution on the sampling surface and mop it with sterile cloth.
5.4.5 After sampling incubate the plates at 30°C-35°C for 72 Hrs.
5.4.6 Sampling point of Rodac plate.
5.4.7 Record the results.

5.5 Finger Prints & Gowning

5.5.1 Frequency: Twice in a month.
5.5.2 For Finger Print:- Prepare Sterile S.C.D agar plate as per SOP.
5.5.3 For Gowning:- Prepare Sterile Rodac Plate as per SOP.
Finger Print:-
5.5.4 Take the prints of fingertips of Microbiologist during working from both gloves on two different Soybean Casein Digest Agar Plate.
5.5.5 Take the prints of fingertips of the worker during cleaning of sterility room & Inoculation room from both gloves on two different Soybean casein Digest Agar plate.
5.5.6 Mark the plate with left and right hand and Name of the person.
5.5.7 Instruct the person to change the gloves immediately.
5.5.8 After sampling, Incubate the plates at 30°C-35°C for 72 Hrs.
5.5.9 Record the Results.
Gowning:-
5.5.10 Take the sample for gowning after completion of work.
5.5.11 Contact Rodac plate on the gown from the lower part of both selves, Chest and the front of the collar of the person working in sterility testing room.
5.5.12 Send that gown immediately for washing/cleaning.
5.5.13 After sampling incubate the plates at 30°C-35°C for 72 hours.
5.5.14 Record the result.

5.6 Non-Viable Particle Count of Air

5.6.1 Frequency: Once in a month.
5.6.2 Two location, should be sampled during working activity for all sampling sites and at every location, three reading should be taken.
5.6.3 Each reading should be taken over a period of one min. Corresponding to one ft3 of air.
5.6.4 Operate the instrument as per SOP.
5.6.5 The results are calculated and stated as per Particle per ft3 (FED-STD-209E).
5.6.6 Sampling point for Non-viable air particle count.
5.6.7 Record the result.

6.0 ABBREVIATIONS

CFU = Colony Forming Unit
LAF = Laminar Air Flow
PDA =Potato Dextrose agar
SOP = Standard operating procedure
IPA = Isopropyl alcohol
SCD = Soybean casein digest





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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