Standard Operating Procedure for Microbial Testing of Transdermal Patches

1) Purpose

The purpose of this SOP is to outline the procedure for conducting microbial testing of transdermal patches to ensure they meet the required microbiological quality standards.

2) Scope

This SOP applies to all microbial testing activities for transdermal patches manufactured within the facility, including sample collection, testing, and documentation.

3) Responsibilities

The Microbiology Laboratory is responsible for performing and documenting microbial tests as per this SOP. The Microbiology Manager ensures compliance with this procedure and regulatory requirements.

4) Procedure

4.1 Sample Collection

• 4.1.1 Select samples of transdermal patches from the production batch.
• 4.1.2 Label the samples with the batch number and date of collection.
• 4.1.3 Document the sample details in the microbial testing logbook.

4.2 Preparation

• 4.2.1 Prepare the necessary media, reagents, and equipment for testing.
• 4.2.2 Sterilize all equipment and work surfaces to prevent contamination.

4.3 Testing Procedures

• 4.3.1 Total Aerobic Microbial Count (TAMC):
  • 4.3.1.1 Homogenize the transdermal patch samples in a sterile diluent.
  • 4.3.1.2 Plate aliquots of the homogenate onto suitable agar plates.
  • 4.3.1.3 Incubate the plates at 30-35°C for 3-5 days.
  • 4.3.1.4 Count the number of colonies and record the TAMC.
• 4.3.2 Total Yeast and Mold Count (TYMC):
  • 4.3.2.1 Homogenize the transdermal patch samples in a sterile diluent.
  • 4.3.2.2 Plate aliquots of the homogenate onto Sabouraud Dextrose Agar plates.
  • 4.3.2.3 Incubate the plates at 20-25°C for 5-7 days.
  • 4.3.2.4 Count the number of colonies and record the TYMC.
• 4.3.3 Pathogen Testing:
  • 4.3.3.1 Test for specific pathogens (e.g., E. coli, S. aureus, P. aeruginosa) as per regulatory requirements.
  • 4.3.3.2 Use selective media and incubation conditions suitable for each pathogen.
  • 4.3.3.3 Record the presence or absence of each pathogen.

4.4 Interpretation of Results

• 4.4.1 Compare the microbial counts with the acceptance criteria.
• 4.4.2 Document any deviations or out-of-specification results.

4.5 Documentation

• 4.5.1 Record all test results in the microbial testing data sheet.
• 4.5.2 Review and approve the microbial data before archiving.
• 4.5.3 Retain samples and records as per regulatory requirements.

5) Abbreviations, if any

TAMC: Total Aerobic Microbial Count
TYMC: Total Yeast and Mold Count

6) Documents, if any

Microbial Testing Logbook
Microbial Testing Data Sheets

7) Reference, if any

USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

8) SOP Version

Version 1.0