Standard Operating Procedure for Sterility Testing in Aseptic Creams
1) Purpose
The purpose of this SOP is to define procedures for conducting sterility testing on aseptic creams. This ensures that creams are free from viable microorganisms that could compromise product safety and quality.
2) Scope
This SOP applies to the Quality Control Department and personnel responsible for conducting sterility testing of aseptic creams. It covers testing methods, acceptance criteria, documentation, and reporting requirements.
3) Responsibilities
The Quality Control Manager is responsible for overseeing sterility testing activities. The Quality Control Team and Testing Technicians are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Sampling
4.1.1 Select representative samples of aseptic creams from the batch for testing.
4.1.2 Ensure samples are taken aseptically and in accordance with sampling plans.
4.1.3 Label each sample with batch information and identification numbers.
4.2 Test Method Selection
4.2.1 Choose appropriate sterility testing method(s) based on product characteristics and regulatory requirements (e.g., membrane filtration, direct inoculation).
4.2.2 Validate selected testing methods as per established protocols and acceptance criteria.
4.3 Sample Preparation
4.3.1 Prepare cream samples for sterility testing under controlled and aseptic conditions.
4.3.2 Ensure samples are handled carefully to avoid contamination during preparation.
4.4 Testing Procedure
4.4.1 Execute sterility testing according to validated methods and
4.4.2 Incubate samples under appropriate conditions and durations as specified in testing protocols.
4.4.3 Perform microbial growth promotion testing concurrently with sterility testing.
4.5 Examination and Interpretation
4.5.1 Examine incubated samples for evidence of microbial growth using appropriate techniques (e.g., visual inspection, culture methods).
4.5.2 Interpret test results based on growth or absence thereof and compare against acceptance criteria.
4.6 Documentation and Reporting
4.6.1 Document all sterility testing activities, including sampling, preparation, testing methods, procedures, results, and observations.
4.6.2 Prepare sterility testing reports summarizing test conditions, results, conclusions, and recommendations.
4.6.3 Obtain approval from Quality Control Management for sterility testing reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
Sterility Testing Protocols
Sterility Testing Reports
Validation Reports for Testing Methods
7) Reference, if any
USP
Company-specific testing procedures for sterility testing
8) SOP Version
Version 1.0