Standard Operating Procedure for Sterility Testing in Aseptic Aerosols
1) Purpose
The purpose of this SOP is to define procedures for conducting sterility testing on aseptic aerosol products to ensure absence of viable microorganisms.
2) Scope
This SOP applies to sterility testing performed on aseptic aerosol products manufactured by [Company Name] to verify product sterility and compliance with regulatory standards.
3) Responsibilities
Microbiology Laboratory: Perform sterility testing according to approved protocols and regulatory guidelines.
Quality Control (QC) Team: Provide aerosol samples for testing and coordinate sample collection.
Regulatory Affairs: Review and approve sterility testing protocols to ensure compliance with regulatory guidelines.
Quality Assurance (QA) Team: Oversee adherence to SOPs and ensure documentation accuracy and completeness.
4) Procedure
4.1 Sample Collection and Preparation:
4.1.1 Collect representative samples of aseptic aerosol products from the final production batch under aseptic conditions.
4.1.2 Ensure samples are properly labeled and identified to maintain traceability.
4.1.3 Store samples under appropriate conditions (e.g., refrigerated) prior to testing to preserve sample integrity.
4.2 Test Setup and Inoculation:
4.2.1 Prepare culture media and growth promotion tests according to compendial requirements (e.g., USP, EP).
4.2.2 Inoculate samples into culture media under aseptic conditions, ensuring proper mixing and dispersion.
4.2.3 Incubate inoculated culture media under suitable conditions to promote microbial growth.
4.3 Incubation and Examination:
4.3.1 Incubate inoculated culture media for the specified duration according to compendial requirements (e.g., 14 days).
4.3.2 Perform visual and microscopic examinations for evidence of microbial growth at regular intervals during the incubation period.
4.3.3 Record and document observations, including any turbidity, gas production, or other indicators of microbial growth.
4.4 Controls and Validation:
4.4.1 Include appropriate positive and negative controls in each sterility test to validate test procedures and culture media.
4.4.2 Document control results and ensure they meet acceptance criteria before interpreting test results.
4.4.3 Perform validation of sterility testing methods and procedures as per regulatory requirements.
4.5 Result Interpretation:
4.5.1 Evaluate test results after the specified incubation period to determine presence or absence of microbial growth.
4.5.2 Interpret results according to predefined acceptance criteria for sterility testing.
4.5.3 Document all test results, including raw data, observations, and interpretations.
4.6 Reporting and Documentation:
4.6.1 Prepare detailed sterility test reports summarizing testing methods, results, and conclusions.
4.6.2 Review and approve test reports by designated personnel to ensure accuracy and compliance with SOPs.
4.6.3 Maintain records of all sterility testing activities, including sample preparation, incubation, examination, and approval documentation.
4.7 Non-Conformance Handling:
4.7.1 Initiate non-conformance reports (NCRs) for aseptic aerosol products that fail sterility testing or exceed acceptance criteria.
4.7.2 Investigate root causes of non-conformance and implement corrective actions to prevent recurrence.
4.7.3 Verify effectiveness of corrective actions through retesting and document outcomes accordingly.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
NCR: Non-Conformance Report
6) Documents, if any
Sterility Testing Protocol
Sterility Test Reports
Culture Media Preparation Records
Validation Reports for Sterility Testing Methods
Non-Conformance Reports (NCRs)
Approval Records and Documentation
7) Reference, if any
USP Chapter
EP Chapter
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0
