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