Standard Operating Procedure for Microbial Testing in Lotion Manufacturing

1) Purpose

The purpose of this SOP is to outline the procedure for conducting microbial testing of lotions to ensure the product is free from harmful microorganisms and complies with microbial limits.

2) Scope

This SOP applies to all personnel involved in the microbial testing of lotions within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Microbiology Analysts:

• Perform microbial tests according to this SOP and document results accurately.
• Ensure all microbiological equipment is calibrated and maintained.

Quality Control Personnel:

• Review and verify microbial test results for accuracy and compliance with specifications.

Quality Assurance Personnel:

• Ensure that the microbial testing program complies with regulatory requirements.

4) Procedure

4.1 Sample Collection:

• Collect samples from the production batch aseptically as per the sampling plan.
• Label the samples with batch number, date, and time of collection.

4.2 Testing Environment:

• Ensure the microbiology lab is clean and sanitized before testing.
• Maintain aseptic conditions throughout the testing process.

4.3 Microbial Testing Methods:

1. Total Aerobic Microbial Count (TAMC):
   1. Prepare serial dilutions of the lotion sample.
   2. Inoculate appropriate agar plates with the dilutions.
   3. Incubate the plates at 30-35°C for 48-72 hours.
   4. Count the colonies and calculate the TAMC.
2. Total Yeast and Mold Count (TYMC):
   1. Prepare serial dilutions of the lotion sample.
   2. Inoculate Sabouraud dextrose agar plates with the dilutions.
   3. Incubate the plates at 20-25°C for 5-7 days.
   4. Count the colonies and calculate the TYMC.
3. Pathogen Testing:
   • Staphylococcus aureus: Perform tests using Mannitol Salt Agar (MSA) plates and incubate at 30-35°C for 24-48 hours. Confirm with coagulase test.
   • Pseudomonas aeruginosa: Perform tests using Cetrimide Agar plates and incubate at 30-35°C for 24-48 hours. Confirm with oxidase test.
   • Candida albicans: Perform tests using Sabouraud Dextrose Agar plates and incubate at 20-25°C for 48-72 hours. Confirm with germ tube test.

4.4 Interpretation of Results:

• Compare the microbial counts with the acceptance criteria specified in the product specifications.
• Document any deviations and investigate the cause.

4.5 Documentation:

• Record all test results in the microbiology logbook and in the batch record.
• Ensure all deviations are documented and investigated promptly.

5) Abbreviations, if any

TAMC: Total Aerobic Microbial Count

TYMC: Total Yeast and Mold Count

6) Documents, if any

• Microbiology Logbook
• Batch Record
• Standard Test Procedures (STPs)

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