Standard Operating Procedure for Microbial Limits Testing for Aerosols
1) Purpose
The purpose of this SOP is to define procedures for conducting microbial limits testing on aerosol products to ensure compliance with microbiological quality standards and regulatory requirements.
2) Scope
This SOP applies to microbial limits testing performed on aerosol products manufactured by [Company Name] to assess microbial contamination levels and ensure product safety and efficacy.
3) Responsibilities
Microbiology Laboratory: Perform microbial limits testing according to approved protocols and standard operating procedures.
Quality Control (QC) Team: Coordinate sample collection and testing schedules.
Regulatory Affairs: Review and approve microbial limits 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 aerosol products from the final production batch.
4.1.2 Ensure samples are collected aseptically to prevent contamination during handling.
4.1.3 Label samples with unique identifiers and store under appropriate conditions prior to testing.
4.2 Testing Methods:
4.2.1 Perform microbial enumeration tests to quantify total aerobic microbial count (TAMC) and total yeast and mold count (TYMC).
4.2.2 Conduct tests for specific pathogens or indicator organisms as required by regulatory guidelines.
4.2.3 Use
4.3 Incubation and Analysis:
4.3.1 Inoculate samples onto appropriate agar plates or culture media under controlled conditions.
4.3.2 Incubate plates at specified temperatures and durations to promote microbial growth.
4.3.3 Perform colony counting and identification of microbial colonies based on morphology and biochemical characteristics.
4.4 Interpretation of Results:
4.4.1 Calculate microbial counts per unit volume or weight of aerosol product based on colony-forming units (CFU).
4.4.2 Compare test results against acceptance criteria defined in pharmacopeial monographs or internal specifications.
4.4.3 Record and document all test results, including raw data, calculations, and interpretations.
4.5 Reporting and Documentation:
4.5.1 Prepare comprehensive microbial limits test reports summarizing testing methods, results, and conclusions.
4.5.2 Review and approve test reports by designated personnel to ensure accuracy and compliance with SOPs.
4.5.3 Maintain records of all microbial limits testing activities, including sample preparation, testing protocols, and approval documentation.
4.6 Non-Conformance Handling:
4.6.1 Initiate non-conformance reports (NCRs) for aerosol products that exceed microbial limits or fail acceptance criteria.
4.6.2 Investigate root causes of non-conformance and implement corrective actions to prevent recurrence.
4.6.3 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
TAMC: Total Aerobic Microbial Count
TYMC: Total Yeast and Mold Count
CFU: Colony-Forming Unit
NCR: Non-Conformance Report
6) Documents, if any
Microbial Limits Testing Protocol
Microbial Limits Test Reports
Equipment Calibration Records
Non-Conformance Reports (NCRs)
Approval Records and Documentation
7) Reference, if any
USP Chapter
ISO 14644: Cleanrooms and associated controlled environments
ICH Q9: Quality Risk Management
8) SOP Version
Version 1.0