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SOP for Environmental Monitoring Procedure in Production, R&D and Microbiology Laboratory

OBJECTIVE
To lay down a procedure for Environmental Monitoring in Production, sampling booths, dispensing booths, R&D and Microbiology Laboratory.

SCOPE
This procedure is applicable to the specified areas in Production, Sampling booths, Dispensing booths, R&D and Microbiology laboratory at XYZ Limited.

RESPONSIBILITY
Microbiologist - Execution of activity
Section In-charge – To review the activity
QC Head - To implement the procedure
QA Head - Overall Compliance.

PROCEDURE
Media Plates Preparation
  • Prepare SCDA and SDA plates as per current version of SOP and pre incubate the prepared SCDA plates at 30°C to 35°C for 24 to 48 hours and SDA plates at 20°C to 25°C for 24 to 48 hours.
  • After completion of incubation period observe the plates, if any contamination observed discard the contaminated plates and use the plates which are free from contamination.
  • Before going to start the environmental monitoring ensure the cleaning of the respective areas.
Environmental Monitoring Procedure:
  • Environmental Monitoring can be done by two methods
  1. Passive air sampling method (Settle plate method) and
  2. Active air sampling method (Air sampler method).
Passive air sampling method (Settle Plate Method):
  • Use pre incubated plates of Soya bean Casein Digest Agar (SCDA) for TAMC and Sabouraud Dextrose Agar (SDA) for TYMC.
  • Label each pre incubated SCDA and SDA plates with name of the media, name of the location, and date of exposing.
  • Carry pre labelled plates in stainless steel petri plate carrier which is previously wiped with 70% IPA to the respective locations.
  • Follow the gowning procedure as required by the respective department to avoid the additional contamination.
  • Wipe the hands with 70% IPA and expose the plates by opening the lid on the designated plate exposure stands where ever applicable and it should be perform as per current lay out given by QA.
  • Expose SCDA & SDA plates for four hours in locations mentioned in Annexure - I & II except LAF chambers in microbiology lab, RLAF unit in sampling & dispensing rooms and pass boxes.
  • Expose SCDA & SDA plates for one hour in LAF chambers in microbiology, pass boxes and RLAF unit in sampling and dispensing rooms.
  • After exposing, close the lid & collect all exposed plates in stainless steel petri plate carrier which is previously wiped with 70% IPA and bring to microbiology lab for incubation.
  • Incubate SCDA plates at 30°C to 35°C for 72 hrs and SDA plates at 20°C to 25°C for 5 days.
  • Incubate a negative control plate which is not exposed.
  • Count the colony forming units in the plate at the end of incubation time and record the results in Annexure I & II.
  • Frequency: Once in a month ± 5 working days for locations mentioned in Annexure – II and daily for locations mentioned in Annexure - I.
  • Limits:
  1. Limit for plate exposure of Grade A locations is <1 cfu/plate.
  2. Limit for plate exposure of Grade C locations is 50 cfu/plate.
  3. Standard Limit for plate exposure of Grade D locations is 100 cfu/plate.
  4. Alert limit for plate exposure of Grade D locations is: 50 cfu/plate.
  5. Action limit for plate exposure of Grade D locations is: 60 cfu/plate.
  • Acceptance Criteria:
  1. Bacterial colonies shall be within the limit.
  2. Fungal colonies shall be absent.

Active Air Sampling method (Air Sampler method):
  • Use pre incubated plates of Soya bean Casein Digest Agar (SCDA) for air sampling method.
  • Label each pre incubated SCDA plates with name of the media, name of the location, and date of sampling.
  • Carry pre labelled plates in stainless steel petri plate carrier which is previously wiped with 70% IPA and air sampler unit to the respective locations.
  • Follow the gowning procedure as required by the respective department to avoid the additional contamination.
  • Wipe the hands with 70% IPA, open the lid and place the media plates in the stainless steel petri plate holder cup of air sampler carefully and perform the air sampling as per the current version of SOP No: QC/MB/036.
  • Sample 1000 liters of air in 10 minutes (with the speed of 100lit/min) per location mentioned in Annexure - III & IV and it should be perform as per current lay out given by QA.
  • After completion of air sampling, collect the plates in stainless steel petri plate carrier which is previously wiped with 70% IPA and bring to microbiology lab for incubation.
  • Incubate SCDA plates at 30°C to 35°C for 48 hrs in bacteriological incubator and then transfer to BOD incubator and incubate at 20°C to 25°C for 72 hrs.
  • Incubate a negative control plate which is not exposed.
  • Count the colony forming units in the plate at the end of incubation time and use conversion table given in annexure-I of SOP QC/MB/036 (Operation and calibration procedure of Centrifugal Air Sampler) to report the results as cfu/1000 litres of air (cfu/m3). Record the results in Annexure III & IV.
  • Frequency: Once in a month ± 5 working days for locations mentioned in Annexure III & IV.
  • Limits:
  1. Limit for air sampling of Grade A locations is < 1 cfu/m3.
  2. Limit for air sampling of Grade C locations is 100 cfu/m3.
  3. Standard Limit for air sampling of Grade D locations is 200 cfu/m3.
  4. Alert limit for air sampling of Grade D locations is: 100 cfu/m3.
  5. Action limit for air sampling of Grade D locations is: 150 cfu/m3.
  • Acceptance Criteria:
  1. Bacterial colonies shall be within the limit.
  2. Fungal colonies shall be absent.
Action plan for count exceeding alert limit:
  • During routine monitoring if the environmental monitoring count exceeds alert limit, it has to be brought to the notice of section in-charge, QA department, production department, and maintenance department and necessary actions has to be taken to reduce the microbial load.
  • Cleaning frequency interval shall be decreased and after every cleaning activity perform the environmental monitoring to check the bio-load.
  • Continue the above procedure till the bio-load level comes below alert limit.
  • During this period production activity will be continued.

Action plan for count exceeding action limit:
  • During routine monitoring if the environmental monitoring count exceeds action limit, it has to be brought to the notice of section in-charge, QA department, production department and maintenance department and necessary actions has to be taken to reduce the microbial load.
  • The source of the contamination shall be investigated through deviation control. Sources could include heating, ventilating, and air conditioning (HVAC) systems, damaged HEPA filters, and changes in personnel garbing habits or working practices.
  • During this period production activity will be stopped.
  • Thoroughly sanitize the areas by means of Fumigation.
  • Keep the areas clean and dry and sanitize the equipments with 70% IPA solution.
  • Minimize the movements in production area.
  • After above necessary actions perform environmental monitoring to check the Bio-load levels.
  • Repeat the above procedure till the bio-load level comes below alert limit.
Action plan for count exceeding standard limit:
  • During routine monitoring if the environmental monitoring count exceeds standard limit, it has to be brought to the notice of section in-charge, QA department, production department and maintenance department and necessary actions has to be taken to reduce the microbial load.
  • Inform to the manufacturing department to stop the activity in that particular area.
  • Carry out the fumigation activity and proper cleaning procedure.
  • Clean the area, walls, floor, with disinfectants and frequently change the disinfectant solution.
  • After fumigation and cleaning activity perform the environmental monitoring to check the bio-load level.
  • Continue the above procedure till the bio-load level comes below alert limit.
ABBREVIATIONS
QC: Quality Control
QA: Quality Assurance
SOP: Standard Operating Procedure
CFU: Colony Forming Unit
SCDA: Soyabean Casein Digest Agar
SDA: Sabouraud Dextrose Agar
TAMC: Total Aerobic Microbial Count
LAF: Laminar Air Flow
TYMC: Total Yeasts & Mold Count
NMT: Not more than
RLAF: Reverse Laminar Air Flow

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