SOP FOR PLATE COUNT OF STERILE AREA

Objective: To assess the microbial contamination level in a sterile area by performing a Plate Count.

Scope: This SOP applies to all personnel involved in Plate Count assessments in sterile areas.

Procedure:

Preparation:

a. Ensure the laboratory or area to be tested is in a clean and controlled state.

b. Ensure all equipment and materials are sterilized or properly disinfected.

Sample Collection:

a. Aseptically collect samples from pre-defined locations within the sterile area.

b. Use sterilized swabs or agar plates for sample collection.

c. Record the location, date, and time of each sample collection.

Inoculation:

a. Aseptically transfer the collected samples onto suitable agar plates (e.g., Tryptic Soy Agar).

b. Use a calibrated spreader for uniform spreading.

c. Incubate the agar plates under appropriate conditions.

Incubation:

a. Incubate the plates at the specified temperature (typically 30-35°C) for an appropriate period
(usually 48-72 hours).

Enumeration:
a. After incubation, count the visible colonies on the agar plates.

b. Calculate the Plate Count (CFU/plate) based on the counts obtained.

Data Analysis:

a. Compare Plate Count results with established specifications.

b. Investigate and document any out-of-specification results.

Reporting:

a. Prepare a Plate Count report, including all test results and any deviations.

b. Maintain records as per regulatory requirements.

Equipment Maintenance:

a. Regularly calibrate and maintain all equipment used for Plate Count assessments.

b. Document equipment maintenance activities.