Standard Operating Procedure for Bioburden Testing

1) Purpose

This SOP outlines the procedures for conducting bioburden testing on pharmaceutical products to ensure they meet acceptable microbiological quality standards, ensuring product safety and compliance with regulatory requirements.

2) Scope

This SOP applies to all pharmaceutical products requiring bioburden testing, including raw materials, in-process samples, and finished products.

3) Responsibilities

The Microbiology department is responsible for performing bioburden testing. Quality Assurance (QA) is responsible for overseeing the testing process and ensuring compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the bioburden testing protocol and ensure all necessary materials and equipment are available (e.g., culture media, incubators, sterile containers).
2. Verify the cleanliness and sterility of the testing environment and equipment.

4.2 Sample Collection

1. Collect samples aseptically as per the sampling plan. Ensure samples are representative of the batch and handled in a manner that prevents contamination.
2. Label the samples with all relevant information (e.g., product name, batch number, date of sampling).

4.3 Testing Method

1. Prepare the test sample by diluting it in a suitable diluent according to the bioburden testing protocol.
2. Filter the diluted sample through a membrane filter to capture any microorganisms present.
3. Transfer the membrane filter onto the surface of the appropriate culture media (e.g., TSA, SDA) in Petri dishes.
4. Incubate the Petri dishes at the specified temperature and duration as outlined in the protocol.
5. After the incubation period, count the number of colony-forming units (CFUs) on each membrane filter.

4.4 Data Analysis and Interpretation

1. Record the CFU counts for each sample tested.
2. Compare the CFU counts against the acceptance criteria defined in the testing protocol.
3. Interpret the results to determine if the product meets the bioburden limits requirements.

4.5 Reporting and Documentation

1. Document all testing activities, observations, and results in the appropriate logbooks and records.
2. Prepare a bioburden test report summarizing the findings, including any deviations or observations.
3. Review and approve the test report to ensure accuracy and compliance with regulatory requirements.

4.6 Corrective and Preventive Actions (CAPA)

1. Initiate CAPA procedures if test results indicate non-compliance with bioburden limits.
2. Implement corrective actions to address the root cause of any contamination and prevent recurrence.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
CFU: Colony-Forming Units
CAPA: Corrective and Preventive Actions

6) Documents, if any

Bioburden Testing Protocol, Sampling Records, Test Results Logbooks, Bioburden Test Reports, CAPA Records

7) Reference, if any

Regulatory guidelines such as USP <1227> Validation of Microbial Recovery from Pharmacopeial Articles, ISO 11737-1 Sterilization of Health Care Products – Microbiological Methods – Part 1: Determination of a Population of Microorganisms on Products, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

8) SOP Version

Version 1.0