MDI Microbial Testing Procedures
1) Purpose
The purpose of this SOP is to establish the procedures for conducting microbial testing of metered-dose inhalers (MDIs) to ensure they meet microbiological quality standards and are safe for use.
2) Scope
This SOP applies to all personnel involved in the microbial testing of MDIs at the manufacturing facility, including microbiologists and quality control staff.
3) Responsibilities
The responsibilities for this SOP include performing microbial tests accurately, documenting results, and ensuring compliance with regulatory standards. Specific roles include:
Microbiologists: Conduct microbial testing as specified.
Quality Control Staff: Review and document the results of microbial tests.
4) Procedure
4.1 Sample Collection
4.1.1 Collect MDI samples from each batch following the sampling plan.
4.1.2 Label and handle samples to prevent contamination.
4.2 Preparation for Testing
4.2.1 Prepare the testing environment by sterilizing equipment and surfaces.
4.2.2 Prepare culture media and control organisms.
4.3 Microbial Limit Testing
4.3.1 Plate the MDI samples on appropriate culture media.
4.3.2 Incubate the plates under specified conditions (e.g., temperature, time).
4.3.3 Count and record the number of colony-forming units (CFUs).
4.4 Sterility Testing
4.4.1 Inoculate MDI samples into sterile media.
4.4.2 Incubate the samples under specified conditions.
4.4.3 Observe for any signs of microbial growth.
4.5 Documentation
4.5.1 Record all test results in the microbial testing logbook.
4.5.2 Maintain records of media preparation, control tests, and environmental monitoring.
4.6 Data Analysis
4.6.1 Analyze the microbial data to ensure it meets acceptance criteria.
4.6.2 Investigate any out-of-specification (OOS) results and document findings.
4.7 Reporting
4.7.1 Prepare a microbial testing report summarizing the findings.
4.7.2 Submit the report to the quality assurance department for review and approval.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
CFU: Colony-Forming Unit
OOS: Out of Specification
6) Documents, if any
Microbial testing records, media preparation logs, and environmental monitoring records should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for microbial testing standards.
8) SOP Version
Version 1.0
