Pharma Tips

Microbial Count Monitoring in Production Area

By: Pharma Tips | Views: 3826 | Date: 05-Oct-2011

To estimate Microbial Load in Production Area.

1.0 Objective
To estimate Microbial Load in Production Area.

2.0 SCOPE
This SOP is applicable to Quality Control Department (Microbiology Lab).

3.0 Responsibility
Microbiologist

4.0 Accountability
Department Head

5.0 PROCEDURE

5.1 Plate Exposure method :
5.1.1 Prepare Soyabean Casein Digest agar (SCDA) and Sabouraud Dextrose agar (SDA)plates as per the current version of sop no. 32QC071 .
5.1.2 Incubate the plates for 24 hours at 37°C.
5.1.3 Carry the plates to production area for exposure.
5.1.4 Put the hand gloves and Clean the surface and outer side of plate by 70% isopropyl alcohol.
5.1.5 Open the plate carefully and keep it asper the time maintioned bellow .

5.1.6 Duration of Exposure :
30 minutes under working condition.
60 minutes under non-working condition.
5.1.6 After specified period of exposure, close the plates carefully and bring back to QC lab and incubate SCD agar plates at 37°C and SD agar plates at 22° C. plates after 5 days for colony forming units . Count colonies and record the result as per annexure-I .
5.1.8 Acceptable Microbial Levels


5.2 Air sampling with Dyna test air sampler :
Wrap the agar strip holder with aluminium foil and autoclave at 121°C (15 lbs) for 15 minutes. Carry the Dyna test unit to the test location. Carefully insert the pre sterilized agar strip into the holder and assemble the unit. Load the cells or connect the power point. Keep the timer switch at position one, sample the air for one minute. Focus the agar strip holder towards the area which is to be tested. Switch on the unit. After one minute the instrument will shut off automatically. Remove the agar strip from the holder and keep in the ‘case’ provided and incubate at desired temperature for 48-72 hours. Report the result as c.f.u/40 L of air samples. The instrument can draw 40 L of air on to the agar strip per minute.

5.2.2 Acceptable Microbial Levels :


5.3 Control :
5.3.1 If results are above alert limit, inform to concern supervisor to clean the area.
5.3.2 In case results reach the action levels, instructions will be given to concerned to stop the production. The process will be started only after rectification measures.

6.0 FREQUENCY
6.1 Twice a month and after each maintenance job.
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