procedure of environmental monitoring in manufacturing aera..

      1.0       Objective

     To lay down a procedure of environmental monitoring in manufacturing aera..

      2.0        Responsibility

      Microbiologist/QC-Executive.

      3.0        Accountability

      Head-QC executive

      4.0         Procedure

      4.1        Environmental monitoring of manufacturing area by settle plate method.

       4.1.1     Prepare the Soyabean Casein Digest Agar (SCDA) media, add 1ml glycerin /100ml of media.

       4.1.2     Sterilize the media and prepare the plates as per SOP

       4.1.3  Label the preincubated (SCDA) plates with respective location, date and time on the base of                     petriplates.

       4.1.4     Open the lid of SCDA plates, and expose the plates in respective areas (for2-4hour).

       4.1.5     After completion of exposure, close the lid and incubate these plates at 20° to 25°C for the first 03 days                     and then incubate it at 30° to 35° C for the next 02 days in inverted position.

 4.1.6     After five (5) days of incubation period, observe the total microbial count and record it in the relevant                format.

            Frequency: Perform microbiological environment monitoring by settle plate method on weekly basis.

      4.2       Personal hygiene of manufacturing area by finger dab method.

4.2.1    Take the finger dab of both the hands with hand gloves on different preincubated SCDA plates.

4.2.2    Label the plate with respective persons name, location, date and sign.

4.2.3    Incubate the plate in inverted position at 20° to 25° C for the first 03 days and then incubate it at 30° to 35°C for the next two days.

4.2.4        After five (5) days of incubation period observe the total microbial count and record the results in Frequency: Perform microbiological environment monitoring for personnel hygiene by finger dab method on fortnightly basis.