Standard Operating Procedure for Sterility Testing in Aseptic Gels
1) Purpose
The purpose of this SOP is to define procedures for conducting sterility testing on aseptic gels to ensure they are free from viable microorganisms.
2) Scope
This SOP applies to the Quality Control (QC) department responsible for performing sterility testing on aseptic gels manufactured at the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC): Perform sterility testing according to defined procedures and standards.
Quality Assurance (QA): Oversee the implementation of sterility testing procedures and ensure compliance with SOPs and regulatory guidelines.
Microbiology Laboratory: Provide technical support and expertise in sterility testing methods and analysis.
4) Procedure
4.1 Sample Collection and Preparation
4.1.1 Collect representative samples from finished aseptic gel batches with documented batch/lot numbers and production records.
4.1.2 Aseptically transfer samples into appropriate containers or test vessels under sterile conditions.
4.2 Incubation
4.2.1 Inoculate the sample into appropriate culture media suitable for detecting a wide range of microorganisms.
4.2.2 Incubate the cultures according to defined conditions (time, temperature) required for the growth of microorganisms.
4.3 Monitoring and Examination
4.3.1 Monitor incubated cultures daily for signs of microbial growth such as turbidity, color change,
4.3.2 Perform sub-culturing of positive samples to confirm the presence of viable microorganisms.
4.4 Negative Control Testing
4.4.1 Include appropriate negative controls in each testing batch to ensure sterility of culture media and testing procedures.
4.4.2 Record and document negative control results to validate sterility testing procedures.
4.5 Interpretation of Results
4.5.1 Interpret test results based on absence or presence of microbial growth in samples and controls.
4.5.2 Document all observations, including any deviations from expected results.
4.6 Compliance Assessment
4.6.1 Evaluate sterility test results against acceptance criteria defined in pharmacopoeial monographs or company specifications.
4.6.2 Document compliance or non-compliance with sterility requirements.
4.7 Reporting and Documentation
4.7.1 Prepare detailed test reports documenting sterility test results, compliance status, and any deviations.
4.7.2 Maintain accurate records of all sterility testing activities, including protocols, data sheets, and reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Sterility Testing Protocols and Procedures
– Incubation Records and Results
– Test Reports and Data Sheets
7) Reference, if any
– Pharmacopoeial monographs (e.g., USP, Ph. Eur.) on sterility testing requirements
– Company-specific sterility testing guidelines
8) SOP Version
Version 1.0