Standard Operating Procedure for environmental monitoring by settle plate method

1.0 Purpose:

To lay down the procedure for environmental monitoring by settle plate method.

2.0 Scope:

This procedure is applicable for environmental monitoring by settle plate method in Microbiology area, Production area and Warehouse area.

sop for environment monitoring by settle plate method

3.0 Responsibility:

Microbiologist/ Designee :

* To perform the sampling and monitoring of settle plate as per frequency.

* To follow procedure defines respective area location.

* To observed the plate as per incubation period.

* To fill the raw data as per format.

* To prepare the trend analysis as per procedure.

Head/ Designee - QC :

* To check and review raw data and trend.

* To review, implement and ensure compliance of SOP.

Head/ Designee - QA :

* To approve, implement and ensure compliance of SOP.

4.0 Procedure:

4.1 General Procedure:

4.1.1 Carry out environment monitoring as per frequency.

4.1.2 The environment monitoring date should be routinely reviewed and analyzed in terms of trends.

4.1.3 Entries in inward record as per record no. MD027-R01-00 and give A.R. number as EM/XX/YY/ZZZZ

Where,

EM= Environment Monitoring

XX= SP (Settle Plate)

YY= Current Calendar Year like 16 stands for 2016.

ZZZZ= Serial Number started from 0001, 0002, 0003 and so on.

4.1.4 Location for settle plate should be decided on the basis of place of exposure of return riser and worst case.

4.1.5 Prepared monthly trend of results with reference the alert limit and action limit in form of trend chart.

4.1.6 The sample should be collected at any state (Rest/Operation) depending upon the predetermined settle plate sampling frequency.

4.2 Settle Plate Method (Passive Air Monitoring):

4.2.1 Prepare soyabean casein digest agar media as per SOP of media preparation.

4.2.2 Sterilize the media as per SOP of media sterilization.

4.2.3 The soyabean casein digest agar media plates are prepared by simply pouring the media into Plates as per media preparation SOP.

4.2.4 Let it solidify and then put it for pre-incubation in incubator of 30-35oC for 48 hours to check for any type of contamination. Discard if any plate founds contaminated.

4.2.5 Label following information on the petriplate to be sampled: Name of media, location, date and time of sampling, and sampling done by.

4.2.6 Carry the plates in closed S.S. container to its location for exposure.

4.2.7 Enter in respective area as per entry procedure and be aware of any other hazards and prohibitions which may apply in respective area.

4.2.8 Open the lid of S.S. container take out SCDA plates and put it on S.S. stand in fully open condition for 4 hrs.

4.2.9 Plates should be exposed on the plate exposing stand provided in respective area at height of one and half foot above the ground.

4.2.10 Clean the S.S. stand with 70% IPA after expose the plate.

4.2.11 Ensure that the surface of the agar is open to the environment by removing the lid of the petriplate.

4.2.12 After the exposure time is over, close the plates carefully and bring back to microbiology laboratory in closed container for incubation.

4.2.13 Incubate the plates at 20 to 25°C for 3 days in BOD incubator.

4.2.14 After completion of 3 days, incubate same plates at 30-35°C for further 2 days in BOD incubator.

4.2.15 Simultaneously, incubate a SCDA media plate without exposure as negative control.

4.2.16 Record the total number of colony forming unit (CFU) observed after completion of 5 days. Maintain the record.

4.3 Frequency:

4.3.1 Once in a Month ±5 days for production area of tablet and capsule.

4.3.2 Laminar Air Flow monitoring of microbiology laboratory should be performed on daily basis.

4.3.3 procuction area of injection should be monitored in every shift.

4.4 Limit:

Class Specified limit CFU/plate (Bacteria) Fungal count

A <1 Nil

B 05 Nil

C 50 Nil

D 100 Nil

4.5 Abnormal Counts Intimation to Respective Area and its Rectification:

4.5.1 Regularly check the incubated plates and record it in regular format.

4.5.2 Report the adverse finding to QC Head/designee and QA Head/designee.

4.5.3 Check it, mark it and send it to the concerned department without any delay.

4.5.4 If the results are out of action limit, immediately inform to concern department for respective area to stop the activity and generate the out of specification and also initiate the investigation till cause has been identified and corrective and preventive actions have been established.

5.0 Abbreviations:

MD-Microbiology Department

QA-Quality Assurance

QC-Quality Control

LAF-Laminar Air Flow

CFU-Colony forming unit

EM-Environment Monitoring

BOD-Biological Oxygen Demand

SOP-Standard Operating procedure

SCDA-Soyabean Casein Digest Agar

SS-Stainless Steel

SP-Settle Plate