SOP on Viable Particulate Monitoring – MLT Testing and Other Areas – Microbiology

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SOP on Viable Particulate Monitoring – MLT Testing and Other Areas – Microbiology

1.0 Objective

1.1 To lay down the procedure for Viable Particulate Monitoring in MLT (Microbial Limit Test) Testing and other designated areas of the Microbiology Laboratory to ensure environmental compliance with acceptable microbiological limits.

2.0 Scope

2.1 This SOP is applicable to viable particulate (microbial) monitoring in MLT Testing, Sub-culturing, Sterilization, Media Preparation, Incubation, and other supporting areas of the Microbiology Laboratory.

3.0 Responsibility

3.1 Chemist or above – Microbiology Laboratory: Execution of environmental monitoring and documentation.
3.2 Head – Microbiology Section: Review of monitoring data and ensuring compliance.

4.0 Accountability

4.1 Head – Quality Control: Overall implementation of the procedure.
4.2 Head – Quality Assurance: Review and compliance oversight.

5.0 Procedure

5.1 General

5.1.1 Viable particulate monitoring in MLT Testing and other areas shall be performed to ensure that environmental conditions comply with specified limits for total viable count.

5.1.2 Monitoring shall be conducted as per defined locations and frequencies.

5.2 Monitoring Methods and Frequency

5.2.1 MLT Testing and Sub-culturing Areas

  • Settle Plates (Passive Air Sampling):

    • Under LAF: Daily under dynamic conditions.

    • Other areas: Once weekly if no activity.

  • Volumetric Air Sampling (Active Air Sampling – Sieve Impaction Method):

    • Once weekly under dynamic conditions.

5.2.2 Sterilization, Media Preparation and Other Areas

  • Monitoring by Settle Plate Method once weekly.

  • Monitoring inside incubators after sanitization once weekly.

5.3 Preparation of Media and Accessories

5.3.1 Prepare and sterilize required SCDA (Soyabean Casein Digest Agar) plates/cassettes and pre-incubate as per SOP  (Sterile Media Preparation).

5.3.2 Sterilize required SS carriers for transporting plates/cassettes.

5.3.3 Disinfect outer surfaces of plates/cassettes using 1% Protasan DS / 1% Combatan / 1% Triple 100 and place in sterile SS carriers.

5.3.4 Transfer plates to respective monitoring areas.

5.3.5 Remove plates from SS carriers and initiate monitoring as per procedure.

5.4 Settle Plate Method (Passive Air Sampling)

5.4.1 Exposure Procedure

  • Bring plate to predefined sampling location.

  • Carefully open lid.

  • Place plate at sampling point or exposure stand (if provided).

  • Keep lid inverted beside plate (inner surface downward).

  • Expose plate for 4 hours.

  • After exposure, close plate carefully.

  • Label bottom of plate with location code, exposure date, media lot number, and date of media preparation.

  • Place plates in SS carriers.

5.4.2 Frequency

  • Under dynamic conditions if activity present.

  • Once weekly if no activity.

5.5 Volumetric Air Sampling (Active Air Sampling)

5.5.1 Perform air sampling at predefined locations (1000 liters per location) as per annexure schematic diagrams.

5.5.2 Operate sieve impaction air sampler as per SOP (Operation, Calibration, Cleaning and Maintenance of M Air T Air Sampler).

5.5.3 Disinfect sieve after each sampling location.

5.5.4 Perform sampling sequentially from higher clean area to lower clean area.

5.5.5 After sampling, label each plate with location code, shift, signature (initial), and date.

5.5.6 Place all sampled plates in SS carriers.

5.5.7 Frequency: Once weekly under dynamic conditions.

5.6 Post-Monitoring Handling

5.6.1 Transfer all plates/cassettes in SS carriers to the incubator room.

5.7 Incubation

5.7.1 Incubate environmental monitoring plates/cassettes as follows:

  • 20–25°C for 72 hours

  • Followed by 30–35°C for additional 48 hours

5.7.2 Observe plates after 72 hours and again after 48 hours of second incubation phase.

5.7.3 Record colony counts in respective report formats.

5.8 Documentation

5.8.1 Record settle plate exposure results for MLT Testing and Sub-culturing Areas as per Annexure.

5.8.2 Record volumetric air sampling results for MLT Testing and Sub-culturing Areas as per Annexure.

5.8.3 Record settle plate monitoring results for Sterilization, Media Preparation, Incubation, and other areas as per Annexure.

5.9 Acceptable Levels

5.9.1 Verify that all monitoring results are within the specified acceptable microbiological limits mentioned in respective annexures.

5.9.2 Any result exceeding the specified limit shall be investigated as per deviation/OOS procedure.

6.0 List of Annexures

Annexure – I: Report of Viable Particles Monitoring by Settle Plate Method – MLT Areas
Annexure – II: Report of Viable Particles Monitoring by Volumetric Air Sampling – MLT Areas
Annexure – III: Report of Viable Particles Monitoring by Settle Plate Method – Other Areas

SOP For Handling of Microbiological Data Deviation (MDD) in Microbiology Laboratory

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