Title:MICROBIOLOGICAL EVALUATION OF SURFACES & EQUIPMENTS IN STERILE AREA

1. PURPOSE:
The test is established to evaluate the microbiological status of the pharmaceutical clean rooms and the controlled environment.
2. SCOPE:
2.1 It is applicable in the pharmaceutical aseptic zones.
3. RESPONSIBILITY:
3.1 Quality Control Manager
3.2 Microbiologist
3.3 Production Officer (concerned)
3.4 Lab. Attendant (Micro)
4. Suitable Apparatus/Equipment/solution/media:
4.1 Petri dishes (sterilized)
4.2 Nutrient agar medium (sterilized)
4.3 Saline solution (sterilized)
4.4 Cotton swabs
4.5 Dry heat oven
4.6 Autoclave
4.7 Incubator at 30-35ºC
5. PROCEDURE

4.2.1 Preparation of petri dishes:

4.2.1.1 Wash petri dishes thoroughly with water, finally rinsed them with distilled water.
4.2.1.2 Sterilized them by placing in dry heat oven for 2 hours at 210-220 ºC.

4.2.2 Preparation of media (nutrient agar):

Media should be prepared, autoclaved and dispensed as directed by the manufacturer.

4.2.2.1 Nutrient agar medium:

Prepare as directed by manufacturer. Dispense the medium in Petri dishes cover with butter paper or aluminum foil and autoclave as described by manufacturer. After autoclave final Ph should be same as recommended by manufacturer.

4.2.3 Methodology for Irregular surfaces:
4.2.3.1 Dip the cotton swabs in 2-4 ml of saline solution and autoclave at 121◦C.
4.2.3.2 Define the sampling places/surfaces in the subjected area.
4.2.3.3 Transfer the vessels containing swabs aseptically to the sampling site.
4.2.3.4 Rub/Swab on the surface to be monitored by selecting an appropriate area.
4.2.3.5 Put the subjected swab back in to the vessel and transfer to the Microbiology Lab. aseptically.
4.2.3.6 Under L.A.F Hood uncover the petri plate and impregnate the swab on the surface of nutrient agar.
4.2.3.7 Incubate at 30-35 ºC in incubator for 48 hours.
4.2.4 Methodology for Regular surfaces:

4.2.4.1 Similar process as above
4.2.4.2 Use S.S. template having an area of 25cm2 for regular surface monitoring.

5. QUALITY RECORD(s)/FORM(s)
The following Quality Records shall be generated and managed in accordance with the Procedure for Control of Company Quality Records (4.12).

Required Record
Quality Record No.
Swab Test Report