SOP FOR SWAB TEST IN ASEPTIC AREA

Objective: To evaluate the microbial contamination level on surfaces in an aseptic area using a Swab
Test.

Scope: This SOP applies to all personnel involved in swab testing within aseptic areas.

Procedure:

Preparation:

a. Ensure the aseptic area is in a clean and controlled state.

b. Verify that all equipment and materials are sterilized or properly disinfected.

Swab Sampling:

a. Select predetermined sampling points within the aseptic area, including critical zones.

b. Label the swab containers with sample details, including location, date, and time.

c. Aseptically moisten the swab with a sterile buffer solution (e.g., saline).

Swabbing Procedure:

a. Swab the selected area with aseptic technique, applying uniform pressure.

b. Ensure thorough coverage of the sampling area.

c. Transfer the swab into the labeled container without touching the swab head.

Microbial Recovery:

a. Aseptically transport the swab samples to the microbiology laboratory.

b. Vortex or shake the swab container to release the microorganisms into the buffer solution.
Inoculation:

a. Aseptically transfer the buffer solution onto suitable agar plates (e.g., Sabouraud agar, R2A agar)
using a calibrated spreader.

b. Incubate the agar plates under appropriate conditions.

Incubation:

a. Incubate the plates at the specified temperature (according to the agar type) for an appropriate
period (usually 48-72 hours).

Enumeration:

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

b. Calculate the Swab Test results based on the counts obtained.

Data Analysis:

a. Compare Swab Test results with established specifications.

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

Reporting:

a. Prepare a Swab Test 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 Swab Testing.

b. Document equipment maintenance activities.