Standard Operating Procedure for Bioburden Testing
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting bioburden testing of pharmaceutical formulations, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure the microbial quality and safety of the product.
2) Scope
This SOP applies to all personnel involved in bioburden testing of pharmaceutical formulations within the pharmaceutical manufacturing facility. It covers the procedures from sample collection to data analysis and reporting.
3) Responsibilities
– Microbiology Department: Responsible for performing bioburden tests and recording data.
– Quality Control (QC) Department: Verifies and documents bioburden test results.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Production Department: Provides samples for bioburden testing as per the testing protocol.
4) Procedure
4.1 Sample Collection
4.1.1 Collect representative samples from the production line or final product as per the sampling plan.
4.1.2 Ensure samples are collected aseptically to avoid contamination.
4.2 Sample Preparation
4.2.1 Prepare the samples by diluting in a sterile diluent if necessary.
4.2.2 Mix the samples thoroughly to ensure a homogeneous suspension.
4.3 Testing Method
4.3.1 Use membrane filtration or pour plate methods for bioburden testing.
4.3.2 Filter a specified volume of the sample through a
4.3.3 Transfer the filter to an appropriate growth medium and incubate under specified conditions.
4.4 Incubation
4.4.1 Incubate the plates at the specified temperature and time (e.g., 30-35°C for 3-5 days).
4.4.2 Ensure that positive and negative controls are included in each test run.
4.5 Enumeration
4.5.1 After incubation, count the number of colony-forming units (CFUs) on each plate.
4.5.2 Record the CFU counts and calculate the bioburden per unit or volume of the sample.
4.6 Data Analysis
4.6.1 Compare the bioburden results against predefined specifications to ensure compliance.
4.6.2 Investigate any results that exceed the acceptable limits to determine the root cause of contamination.
4.7 Documentation
4.7.1 Document all test results, including raw data, CFU counts, and observations, in the bioburden testing logbook or electronic database.
4.7.2 Ensure that all records are reviewed and approved by the QC department.
4.8 Reporting
4.8.1 Prepare a bioburden testing report summarizing the methodology, results, and any deviations observed.
4.8.2 Submit the report to the QA department for review and approval.
4.9 Corrective Actions
4.9.1 If the bioburden exceeds acceptable limits, initiate an investigation to identify the source of contamination.
4.9.2 Implement corrective actions as necessary and document all findings and actions taken.
5) Abbreviations, if any
– IM: Intramuscular
– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance
– CFU: Colony-Forming Units
6) Documents, if any
– Bioburden Testing Logbook
– Bioburden Testing Reports
– Batch Records
7) Reference, if any
– USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests
– ISO 11737-1:2018 Sterilization of Health Care Products – Microbiological Methods
8) SOP Version
Version 1.0