MICROBIAL COUNT OF SURFACE CONTACT PLATE METHOD PROCEDURE

PREPARATION OF MEDIA:

·         Soyabean Casein Digest agar shall be prepared for bacterial and fungal count.

PROCEDURE FOR PREPARATION OF PLATES: Microbial count of Surface contact plate method procedure

·         Sterile Surcon plates packed in plastic bags shall be taken to the laminar air flow station and removed from plastic bags              under laminar flow.

·         16 ml of sterilized media cooled to 450 C is poured aseptically using sterile measuring cylinder in separate surcon plates.

·         Medium shall have allowed to accommodate in the plate until its level is sufficiently higher than the edge of the plates, so that            the surface of media will have convex appearance.

·         Media is allowed to solidify. After solidification the lid is placed   back to its position.

·         Prepared plates are inverted and incubated at 300 C to 350 C for 48 hours to check contamination.

PROCEDURE FOR SAMPLING:

·         After pre incubation of SCD agar are taken to clean area to perform the microbial count test for surfaces.

·         Lid of the plates is removed and the media from the plates is       brought in contact with the surface to be tested by inverting the             plates. The plates are gently and evenly pressed on the surface.

·         The plate is lifted off without sliding along the surface and the lid is replaced by gently pressing.

·         The tested surface is wiped with a disposable cloth moistened with isopropyl Alcohol 70% v/v followed by disinfectant.

·         The plates of Soyabean Casein Digest agar are incubated at 300 C to 350 C for 48 hours for bacteria and then at 20-250 C for 72 hours for fungus.

·         Colony count shall be taken on completion of incubation and results shall be recorded in the protocol attached. Microbial count of Surface contact plate method procedur

EVALUATION: MICROBIAL COUNT OF SURFACE CONTACT PLATE METHOD PROCEDURE

The count of bacterial and fungus observed shall be reported as No. of CFU on SCD agar / 55 mm dia. plate

LIMITS:

Class 100: Grade A: Less than 1 CFU/55 mm dia plate.

Class 10,000 (Filling): Grade C:

Alert Limit - Not More than 10 CFU / 55 mm plate of SCD.

Action Limit - Not More than 20 CFU / 55 mm plate of SCD.

Maximum Limit - 25 CFU / 55 mm plate of SCD.

Class 1,00,000: Grade D:

Alert Limit - Not More than 25 CFU / 55 mm plate of SCD.

Action Limit - Not More than 40 CFU / 55 mm plate of SCD.

Maximum Limit -50 CFU / 55 mm plate of SCD.

ACTION IN CASE OF NON COMPLYING RESULTS MICROBIAL COUNT OF SURFACE CONTACT PLATE METHOD PROCEDURE

·         If number of colonies exceed the alert limits, matter shall be discussed with In-charge production section to take necessary corrective actions with respect to daily sanitization, gowning entry exit procedure working system etc. initiation of change in sampling shall be planned by Q.A., if required.

·         If there is no improvement or the number of colonies exceed action limits, then the matter shall be referred to in-charge production section and Plant Manager. Thorough joint investigation shall be carried out by Quality Assurance Head and Production Head which should include the following points.

·         Review of daily sanitization record and procedures to ensure compliance with relevant work instruction. (Microbial count of Surface contact plate method procedure)

·         Review of the clean area operations including those of Entry / Exit procedures of personnel and material.

·         Investigation and check of personnel working in the clean area for their hygienic condition.

·         Review of environmental parameters like temperature, humidity and differential pressure.

·         Personnel working in the area shall be reviewed for their training status.

·         Depending upon the result of investigation corrective actions shall be immediately taken by suspending the production activities.

·         The area shall be monitored by increasing the frequency of the    different checks for viable and non-viable contaminates to confirm that the area and conditions are restored to normal to restart the activities.

FREQUENCY

WEEKLY: At the end of operation in the area like Filling zone, Filling machine, Manufacturing and Mixing & Storage areas.

Trend of contact plate data shall be done annually