Microbial Monitoring by Plate Exposure

1.0 Objective
To lay down a procedure for Microbial Monitoring by Plate Exposure.
2.0 Scope
This Standard Operating Procedure is applicable for the Microbial Monitoring by Plate Exposure in TAC,

External and Liquid and Microbiology Lab of abc company.
3.0 Responsibility
3.1 Officer / Executive Quality Control Department are responsible for Microbial Monitoring by

Plate Exposure in TAC, DPI, Liquid and Lozenges and Microbiology Lab.
3.2 Head Quality Control is responsible for the compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
TAC : Tablet and capsule block.
D.P. : Drain point
M.L.T. : Microbial limit Test
5.0 Procedure
5.1 For Passive air monitoring
5.1.1 Prepare the required quantity of SCDA media, Sterilize by autoclaving and dispense the media into

required number of Petri plates (90 mm dia.) aseptically.
5.1.2 Keep the solidified plates inside the BOD incubator at 20 oC – 25 oC for 18-24 hours prior

subjecting them for plate exposure?
5.1.3 Before exposure operations, the required per-incubated Petri plates are checked for any microbial

growth. If any microbial growth is observed then immediately discard those Petri plates

having microbial contamination/growth.
5.1.4 If no growth is observed then each plate is marked with respective sampling location point

followed by the date of exposure with the help of pencil marker.
5.1.5 Carry the plates to the desired location for exposure in a cleaned SS container mopped with 70% IPA.
5.1.6 Solidified agar plates are exposed at respective locations by wearing Face mask, Hand gloves rinsed

with 70% IPA solution, Cap and Clean gown for Non sterile areas and for sterile areas the exposure is

done by following proper sterile gowning procedure.
5.1.7 Expose the media containing plate by carefully removing the cover lid of the plate and placing the

media plate on Cleaned SS Petri plate holder/butter paper.
5.1.8 Similarly expose all the Petri plates at their respective locations for 04 hours in sterile areas,

02hours in Non sterile areas and not less than 30 minutes under laminar air flow unit.

Plate exposure operations should be done one feet above the working bench.
5.1.9 After completing the exposure period, collect all the plates from their respective locations in

the same SS container and transfer the SS container to the microbiology laboratory.
5.1.10 Before transferring to microbiology laboratory, mop the outside of the SS container

with 70% IPA and then bring the container to the microbiology laboratory. Microbiologists

should handle the plates by wearing cleaned hand gloves only.
5.1.11 Collect all the exposed plates and unexposed plates in SS container and transfer in BOD

incubator at 20oC – 25oC for 72 hrs days and than incubate the plates by transferring them to

Incubator at 30 oC – 35 oC for the next remaining 48 hrs.
5.1.12 After Incubation counts the number of colonies for each plate representing a respective location.

Record the counts in a respective format.
5.1.13 Plate exposure operations are done once in fortnightly ± 2 days that may vary according to

company’s holiday and other occasions, for liquid block and TAC block of production areas

but this operation is followed during Filling or twice in a week if there is no activity, in sterile

areas of production areas and daily in Microbiology Area.
5.1.14 The alert and action limit of microbial counts for various departments is as follows on their report annexure.
5.2 For Active air monitoring
5.2.1 Sterilize the Stainless steel impaction head assembly as per SOP No.
5.2.2 Sanitize the whole body of the air sampler by mopping with 70% IPA.
5.2.3 Transfer the sterile media filled air sampling cassettes/plate as well as the air sampler to the sampling

location through pass box or change room in areas.
5.2.4 Set the Volume of air to be sampled to 1000 liters and then place the air sampling cassette/plate

on the plate holder of the instrument by removing the lid of the air sampling cassette/plate,

Close the agar cassette with sterilized perforated Stainless steel head adapter immediately;

adopting least exposure to the environment.
5.2.5 Place the Air sampler at the sampling location and start air sampling by pressing twice the

start key present on the operation panel of the equipment.
5.2.6 After air sampling period is over; remove sieve adapter assembly and replace air sampling

cassette lid immediately.
5.2.7 Proceed the air sampling operations in other specified sampling locations in a similar manner

after mopping the SS sieve with 70% of Isopropyl alcohol.
5.2.8 Collect all the sampled Petri plate and unsampled Petri plate (Negative) cassettes/plate inside a

clean IPA mopped SS container with lid and transfer the SS Container from sterile area to incubator

through the location.
5.2.9 Incubate all the plates first at 20 oC – 25 oC for 72 hrs. and followed by at 30o – 35 oC for 48 hrs.
5.2.10 Plate exposure operations are done once in fortnightly ± 2 days that may vary according to

company’s holiday and other occasions, for liquid block and Monthly± 2 days exposure in TAC

block areas but this operation is followed during Filling or twice in a week if there is no activity, in

sterile areas of production areas and daily in Microbiology Area.
5.2.11 After incubation count the number of colonies and report the number of Cfu per cubic meter

Record all the observations properly in controlled format.
5.2.12 Discard all the plates after observation as per SOP No.
5.2.13 Alert and action limits are given in respective annexure.

6.0 Forms and Records
6.1 Environmental Monitoring of Aseptic Area by Passive Air Sampling (Settle plate)- Annexure-1
6.2 Passive Air Sampling Record of Sterility Testing Area – Annexure-2
6.3 Passive Air Sampling Record of Microbiological Testing Area – Annexure-3
6.4 Liquid Manufacturing Area Passive Air Sampling Record – Annexure-4
6.5 Tablet and Capsule Manufacturing Area Passive Air Sampling Record – Annexure-5
6.6 Plate Exposure Schedule – Annexure-6
6.7 Active Air Sampling Record of Microbiological Testing Area – Annexure-7
6.8 Active Air Sampling Record of Sterility Testing Area – Annexure-8
6.9 Environmental Monitoring of Aseptic area By Active Air Sampling – Annexure-9
6.10 Tablet and Capsule Manufacturing Area Active Air Sampling Record – Annexure-10
6.11 Liquid Manufacturing Area Active Air Sampling Record – Annexure-11
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control
8.0 History