Microbiology Analysis of Surface Swab and its SOP

Microbiology Analysis of Surface Swab; Purpose:

To confirm that the processing area & processed equipment’s are free from any intolerable microorganisms & total aerobic count are within specification.

 Microbiology Analysis of Surface Swab; Scope:

This SOP applies to detect or count of bacteria and Yeast/Mold in Non-sterile Processing, Sterile Processing Area & Testing area of Microbiology laboratory at XX Pharmaceuticals Ltd.

 Definition:  

Swab test & Finger Printing are to check with a view to take timely corrective measures for maintaining a favorable manufacturing environment, minimizing the risk of contamination of the products.

Responsibilities:

The roles and responsibility is as follows

Executive/ Senior Executive, Microbiology

Sample collection, analysis of swab and document preparation

Manager, Microbiology

Confirm sampling, analysis, documentation & application of updated technical information.

Head of Quality Assurance

Take initiative to Approval of this SOP

Procedure:

Instructions

• Disinfect with the help of 70% IPA/Ethanol the whole outer surface of machine & all apparatus.
• Wear gloves, mask & sterilized garments before entrance into aseptic area.
• Minimize the movement into aseptic area or others sampling area.

Swab Test of Garments/Floor/Wall/Equipment

Sterilization of Swab Kits and Culture Media

• Prepare swab kits with cotton bud as per requirement.
• Roll tightly a small amount of cotton of surgical grade at one end of the glass rod.
• Place cotton bud in a narrow test tube.
• Plug end of test tube with the help of non-absorbent cotton.
• Prepare CSDA [Casein Soybean Digest Agar], CSDB [Casein Soybean Digest Broth] according to the requirement of the test. Distribute 50ml of CSDB in each conical flask.
• Sterilize media & test tubes containing cotton bud & Template steel plate at 121⁰C & 15lbs pressure for 15 minutes in an autoclave.

Swab Collection

• Select a steel template of 5 x 5 cm. size.
• Sterilize steel template by alcohol flaming before the test
• Wipe cotton bud slowly & firmly in interior direction of steel template on the surface, selected for test.
• Rotate cotton bud against direction of the overall wiping movement.
• Repeat process for three times.

Collected Sample Preservation

• Perform test within 30 minutes after collection of sample.
• Preserve sample at 2 to 8⁰C at not more than 12 hours if test is not performed within 30 minutes.

 Test Method

• Place swab immediately in a bottle containing 50ml of CSDB.
• Pull cotton free in the medium.
• Shake bottle containing swab for sometime in a shaker.
• Pour 1ml of diluent into sterile petridishes with aid of a sterile pipette.
• Add 20 to 25ml of Tryptone Soy Agar at about 45 to 50⁰C to the plate.
• Mix medium with sample by rotating petridish.
• Allow medium to solidify & then keep plate for incubation at 37⁰C for 48 hours.
• After incubation period count number of colonies either by colony counter or visual inspection.
• Carry out the test in every week.

Interpretation of Test Result

• Report swab test if test result found in Swab Test Report, Annexure-I.
• If test result found out of specification, repeat the test.
• Recollect swab sample from same area or same person.
• Carry whole test as previously performed
• If test result found within specification as per table-1, report the test result in Annexure-I.

Personnel Finger Printing :

Culture Media Preparation and Sterilization

• Prepare CSDA [Casein Soybean Digest Agar] for the test according to the requirement of the test following the instructions of the respective manufacturer.
• Autoclave medium at 121⁰C & 15lbs pressure for 15 minutes.
• Pour approximately (20 to 25) ml of medium in each plate after autoclaving.
• Allow medium to solidify & then keep in refrigerator until use.
• Dry surface of agar media.
• Do not use prepared plate after 72 hours.
• Take medium aseptically to respective department.

Collection of Finger Print

• Take finger print of both the hands, of each person working in the aseptic area in the separate plate.
• Mark each plate with person’s name, area /room no., hand (right/left) and date.
• Aseptically bring plates back to microbiology laboratory
• Incubate plates at (30 to 35)⁰C for 48 hours.
• After incubation count number of colony forming unit formed on each plate either by visual examination or by colony counter.
• Carry out test every week for sterile process operator & once in a month for Non-sterile process operator.

 Interpretation of Test Result

• Report swab test if test result found in Swab Test Report, Annexure-I.
• If test result found out of specification, repeat the test.
• Recollect swab sample from same area or same person.
• Carry whole test as previously performed
• If test result found within specification as per table-1, report the test result in Annexure-I.

Out of Specification

If test result found out of specification, send test report to concerned Sectional Head for corrective action.

After corrective action, repeat the test for specific area or person.

Download the All Annexure Here

Annexure 1 Swab (Microbial) Test Report
Annexure II Finger Print Test Report