SOP on Viable Particulate Monitoring – Sterility Testing

SOP on Viable Particulate Monitoring – Sterility Testing

• Objective

To lay down the procedure for Viable Particulate Monitoring – Sterility Testing Area – Microbiology.

• Scope

This SOP is applicable for Viable Particulate Monitoring in Sterility Testing Area of Microbiology lab of (Pharmaceutical Company Name).

• Responsibility
  • Chemist or above of Microbiology Laboratory.
  • Head – Microbiology Section.

• Accountability
  • Head – Quality Control.
  • Head – Quality Assurance.

• Abbreviations and Definitions

SOP            : Standard operating procedure

No.             : Number

QC             : Quality Control

QA             : Quality Assurance

RODAC     : Replicate Organism Detecting and Counting

MLT          : Microbial Limit Test

LAF           : Laminar Air Flow

• Procedure
  • Viable particle monitoring in sterility testing facility shall be performed by microbiologist, to ensure that the environmental conditions of the sterility testing area are in compliance with respect to the acceptable levels of total viable count.
  • Perform the viable particle monitoring in Sterility testing area by following methods.
    • Settle Plates (Passive air sampling).
    • Volumetric Air Sampling (Active air sampling by sieve impaction method).
    • Surface Monitoring by Swabs and 55 mm Surface contact (RODAC) plates.
    • Personnel Monitoring 55 mm Surface contact (RODAC) plates.

• Preparation of plates and other accessories:
  • Prepare and sterilize required number of SCDA (Soya bean Casein Digest agar Medium) plates / cassettes and pre-incubate as per the SOP on sterile media preparation (SOP No.)
  • Sterilize required number of tubes containing 10 ml of saline and a swab and place them in test tube stand.
  • -negative cells stain pink colour.
  • Sterilize required number of SS carriers required to carry plates / cassettes and other accessories.
  • Place the preincubated media plates / cassettes under LAF working zone.
  • Disinfect the outer surfaces of the medium plates / cassettes with 1% Protasan DS / 1% Combatan / 1% Triple 100 and place them in the sterile SS carriers. Place the swab tube stands in the carriers.
  • Carry the plates to the sterilization area.
  • Disinfect outer surfaces of carriers and place them in the dynamic pass box of cooling zone and keep half an hour under the UV light.
  • Enter the sterility testing area through change rooms following sterility testing area entry procedure as per SOP No.
  • After entering in the sterility testing area, ensure that the air sampler is fully charged
  • Disinfect the outer surface of SS carrier placed in the dynamic pass box and take inside.
  • Take out the items from the SS bin and start the monitoring using the procedures mentioned below.
• Settling Plates exposure (Passive air sampling):
  • Expose the agar medium plates at the locations according to the pre-defined locations and settle plate exposure schematic diagrams mentioned in the annexure.
  • Exposure method.
• Bring each plate to the pre-defined locations.
• Open the lid of plate carefully.
• Place the plate containing medium at the location. Place the plate on the settle plate exposure stand if it is provided for that location.
• Place the lid beside this plate internal side down.
• Expose the plates for 4 hours.
• After completion of exposure time, close the medium plate with lid carefully.
• Label each plate on bottom side with location code, date of exposure, media Lot No, and date of media preparation.
• Place all the plates in SS carriers.
  • Perform the monitoring by settle plates daily once under dynamic conditions if activity is there or once in a week if there is no activity.
• Volumetric Air Sampling (Active air sampling by sieve impaction method):
  • Perform the volumetric air sampling in the locations (1000 liters / Location) according to the pre-defined locations and volumetric air sampling schematic diagrams as per Annexure No.
  • Perform Air sampling with sieve impaction Air Sampler, as per SOP NO.
  • Disinfect the sieve after sampling of every location.
  • Perform the volumetric air sampling starting from high clean area location to low clean area location sequentially.
  • After completion of test, label each plate on bottom side with location code, date of exposure, media Lot No, and date of media preparation.
  • Place all the plates in SS carriers.
  • Perform the monitoring by volumetric air sampling once in a week.
• Surface Monitoring by Swabs and 55 mm Surface contact (RODAC) plates:
  • Perform the surface monitoring at the locations according to the pre-defined locations and surface monitoring schematic diagrams mentioned as per Annexure No
  • Perform the surface monitoring by following two methods based on the location as per Annexure No.
• Swab method:
• Aseptically open the test tube containing swab and take out the sterile swab partially, press the swab to the internal walls of the tube gently to remove excess saline and take out completely.
• Swab about 25 cm² (5 cm x 5cm) area in the direction specified in Figure: 1

 Figure: 1

1)      Horizontal Strokes

2) vertical Strokes by rotation of Swab

Place the swab in the saline containing tube and close.

• After completion of test label each plate on bottom side with location code, date of sampling, media Lot No, and date of media preparation.
• Perform the sampling in all the locations as per the sampling plan using same procedure.
• Place all the swab tubes and place the stands in SS carriers.
• 55 mm surface contact (RODAC) plates :
• Perform the surface monitoring in flat surfaces as per annexure No. using 55 mm surface contact (RODAC) plates.
• Carefully open the RODAC plate, invert and touch gently with the convex surface of agar to the surface to be monitored. Press the plate firmly to expose the entire agar surface to the area to be sampled.
• Slowly take back the plate and close the plate with lid. Take care not to leave any traces of agar medium to the surface monitored.
• Disinfect the sampled area and clean with sterile moping pad.
• After completion of test, label each plate on bottom side with location code, date of sampling, media Lot No, and date of media preparation.
• Perform the sampling in all the locations as per the sampling plan using same procedure.
• Place all the plates in SS carriers.
• Perform the monitoring daily once at the end of Sterility testing (before cleaning), or fortnightly if there is no activity.
• Personnel Monitoring 55 mm Surface contact (RODAC) plates:
  • Perform the personnel monitoring for the personnel working in the sterility testing area using 55 mm Surface contact (RODAC) plates.
  • Perform the personnel monitoring for four locations and it should include both hands. Perform the sampling in any two other locations. Refer the schematic diagram mentioned as per Annexure No. for sampling locations.
  • Sampling:
• Perform the personnel monitoring at the locations using 55 mm Surface contact (RODAC) plates as per Annexure No.
• Carefully open the RODAC plate, invert and contact the surface of agar to the surface to be monitored. Press the plate firmly to expose the whole surface of agar to the sample surface.
• Slowly take back the plate and close the plate with lid. Take care to not to leave any traces of agar medium to the surface monitored.
• After completion of test, label each plate on bottom side with location code, date of sampling, media Lot No, and date of media preparation.
• After complete sample collection, place all the plates in SS carriers.
  • Perform the monitoring daily at the end of activity while coming out of sterility area. (Before leaving).
  • After environment and personnel monitoring are over, keep the SS carriers in the dynamic pass box and come out through exit change rooms.
  • Bring all the swab tubes / plates / cassette carriers to incubators room for incubation.
  • Perform the testing of swabs in MLT testing room.
  • First, vortex the saline solution contained in each tube along with swab and filters through a sterile 0.45 µm membrane filter and rinse the membrane filter three times with 100 ml of 0.1% peptone water and place the membrane filter on pre-incubated SCDA medium plate. Use different filter holder for each swab.

• Incubation:
  • Incubate all plates / cassettes of environmental monitoring and personnel monitoring test at 20-25 0C for 72 hours and at 30-35 0C for further 48 hours. Observe the plates / cassettes after 72 hours and after further 48 hours and record the results in respective report formats as per the given annexures.
• Documentation:
  • Record the test details of settle plate exposure for Sterility testing area in the report given as per Annexure No.: (Format No. :).
  • Record the test details of Volumetric Air sampling for Sterility testing area and in the report given as per Annexure No.: (Format No.: ).
  • Record the test details of Surface Monitoring by Swabs and 55 mm Surface contact (RODAC) plates in Sterility testing area in the report given as per Annexure No.: (Format No.: ).
  • Record the test details of Personnel Monitoring Surface contact (RODAC) plates in Sterility testing area in the report given as per Annexure No. 🙁 Format No. 🙂
• Acceptable levels:
  • Verify that the monitoring results are within the acceptable levels mentioned in the particular annexure.
• Forms and Records (Annexures)
  • Report of Viable Particles Monitoring by Settle Plate Method
  • Report of Viable Particles Monitoring by Volumetric Air Sampling
  • Report of Surface Monitoring for Viable Particles by Swabs and Surface Contact plates
  • Report of Personnel Monitoring for Viable Particles by Surface Contact plates
• Distribution
  • Master copy          –     Quality Assurance
  • Controlled copies  –      Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource
• History:

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