STANDARD OPERATING PROCEDUREEnvironmental Monitoring Procedure in Production, R&D and Microbiology Laboratory
STANDARD OPERATING PROCEDURE |
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Department: Quality Control
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SOP No.: QC/MB/xxxx
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Environmental Monitoring Procedure in Production, R&D and
Microbiology Laboratory
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Effective
Date:
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Review
Date:
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Page
No.: 1 of 10
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1.0
OBJECTIVE:
1.1
To lay down a procedure for Environmental Monitoring in Production,
sampling booths, dispensing booths,
R&D and Microbiology Laboratory.
2.0
SCOPE:
2.1
This procedure is applicable to the specified areas in Production,
Sampling booths,
Dispensing booths, R&D and Microbiology laboratory
at Pharma Private Limited.
3.0
RESPONSIBILITY:
3.1
Microbiologist - Execution of activity
3.2
Section In-charge – To review the activity
3.3
QC Head - To implement the procedure
3.4
QA Head - Overall Compliance.
4.0
PROCEDURE:
4.1
Media Plates Preparation:
4.1.1
Prepare SCDA and SDA plates as per current
version of QC/MB/021 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.
4.1.2
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.
4.1.3
Before going to start the environmental monitoring ensure the cleaning of
the respective areas.
4.2
Environmental Monitoring Procedure:
4.2.1
Environmental Monitoring can be done by two
methods
4.2.1.1 Passive air
sampling method (Settle plate method) and
4.2.1.2 Active air
sampling method (Air sampler method).
4.3
Passive air sampling method (Settle Plate Method):
4.3.1
Use pre incubated plates of Soya bean Casein Digest Agar (SCDA) for TAMC
and Sabouraud Dextrose Agar (SDA) for TYMC.
4.3.2
Label each pre incubated SCDA and SDA plates with name of the media, name
of the location, and date of exposing.
4.3.3
Carry pre labelled plates in stainless steel petri plate carrier which is
previously wiped with 70% IPA to the respective locations.
4.3.4
Follow the gowning procedure as required by the respective department to
avoid the additional contamination.
4.3.5
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.
4.3.6
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.
4.3.7
Expose SCDA & SDA plates for one hour in LAF chambers in
microbiology, pass boxes and RLAF unit in sampling and dispensing rooms.
4.3.8
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.
4.3.9
Incubate SCDA plates at 30°C to 35°C for 72 hrs and SDA plates at 20°C to
25°C for 5days.
4.3.10
Incubate a negative control plate which is not exposed.
4.3.11
Count the
colony forming units in the plate at the end of incubation time and record the
results in Annexure I & II.
4.3.12
Frequency: Once
in a month ± 5 working days for locations mentioned in Annexure – II and daily
for locations mentioned in Annexure - I.
4.3.13
Limits:
4.3.13.1 Limit for plate exposure of Grade A locations is
<1 cfu/plate.
4.3.13.2 Limit for plate exposure of Grade C locations is 50
cfu/plate.
4.3.13.3 Standard
Limit for plate exposure of Grade D locations is 100 cfu/plate.
4.3.13.4 Alert limit
for plate exposure of Grade D locations is: 50 cfu/plate.
4.3.13.5 Action
limit for plate exposure of Grade D locations is: 60 cfu/plate.
4.3.14
Acceptance
Criteria:
4.3.14.1 Bacterial
colonies shall be within the limit.
4.3.14.2 Fungal
colonies shall be absent.
4.4
Active Air Sampling method (Air Sampler method):
4.4.1
Use pre incubated plates of Soya bean Casein Digest Agar (SCDA) for air
sampling method.
4.4.2
Label each pre incubated SCDA plates with name of the media, name of the
location, and date of sampling.
4.4.3
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.
4.4.4
Follow the gowning procedure as required by the respective department to
avoid the additional contamination.
4.4.5
Wipe the hands with 70% IPA, open the lid and place
the media plates in the stainless steel petriplate holder cup of air sampler carefully
and perform the air
sampling as per the current version of SOP No: QC/MB/036.
4.4.6
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.
4.4.7
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.
4.4.8
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.
4.4.9
Incubate a negative control plate which is not exposed.
4.4.10
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.
4.4.11
Frequency: Once
in a month ± 5 working days for locations mentioned in Annexure III & IV.
4.4.12
Limits:
4.4.12.1 Limit for
air sampling of Grade A locations is < 1 cfu/m3.
4.4.12.2 Limit for
air sampling of Grade C locations is 100 cfu/m3.
4.4.12.3 Standard
Limit for air sampling of Grade D locations is 200 cfu/m3.
4.4.12.4 Alert limit
for air sampling of Grade D locations is: 100 cfu/m3.
4.4.12.5 Action
limit for air sampling of Grade D locations is: 150 cfu/m3.
4.4.13
Acceptance Criteria:
4.4.13.1 Bacterial
colonies shall be within the limit.
4.4.13.2 Fungal
colonies shall be absent.
4.5
Action plan for count exceeding alert
limit:
4.5.1
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.
4.5.2
Cleaning frequency interval shall be decreased and after every cleaning
activity perform the environmental monitoring to check the bio-load.
4.5.3
Continue the above procedure till the bio-load level comes below alert
limit.
4.5.4
During this period production activity will be continued.
4.6
Action plan for count exceeding
action limit:
4.6.1
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.
4.6.2
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.
4.6.3
During this period production activity will be stopped.
4.6.4
Thoroughly sanitize the areas by means of
Fumigation.
4.6.5
Keep the areas clean and dry and sanitize the
equipments with 70% IPA solution.
4.6.6
Minimize the movements in production area.
4.6.7
After above necessary actions perform environmental monitoring to check
the Bio-load levels.
4.6.8
Repeat the above procedure till the bio-load level comes below alert
limit.
4.7
Action plan for count exceeding
standard limit:
4.7.1
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.
4.7.2
Inform to the manufacturing
department to stop the activity in that particular area.
4.7.3
Carry out the fumigation activity and proper cleaning procedure.
4.7.4
Clean the area, walls, floor, with
disinfectants and frequently change the disinfectant solution.
4.7.5
After fumigation and cleaning activity perform the environmental
monitoring to check the bio-load level.
4.7.6
Continue the above procedure till the bio-load level comes below alert
limit.
5.0
ABBREVIATIONS:
QC: Quality Control
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QA: Quality Assurance
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SOP:
Standard Operating Procedure
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CFU: Colony Forming Unit
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SCDA: Soyabean Casein Digest Agar
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SDA: Sabouraud Dextrose Agar
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TAMC: Total Aerobic Microbial Count
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LAF: Laminar Air Flow
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TYMC: Total Yeasts & Mold Count
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NMT: Not more than
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RLAF: Reverse Laminar Air Flow
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7.0
REFERENCES:
7.1
European Guidelines annexure-I.
7.2
United States of Pharmacopoeia chapter
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