Preservative Efficacy Testing Procedures in MDIs

1) Purpose

The purpose of this SOP is to establish procedures for evaluating the efficacy of preservatives used in metered-dose inhalers (MDIs) to prevent microbial growth and ensure product safety and stability.

2) Scope

This SOP applies to all personnel involved in preservative efficacy testing activities within the MDI production facility, including microbiologists, quality control technicians, and production supervisors.

3) Responsibilities

The responsibilities for this SOP include conducting preservative efficacy testing, interpreting test results, documenting findings, and ensuring compliance with specifications. Specific roles include:
Microbiologists: Perform microbial challenge testing to assess preservative effectiveness.
Quality Control Technicians: Verify test results and ensure compliance with acceptance criteria.
Production Supervisors: Review testing outcomes and authorize product release based on efficacy testing results.

4) Procedure

4.1 Sample Preparation
4.1.1 Prepare MDI samples containing preservatives under aseptic conditions.
4.1.2 Ensure samples are appropriately labeled and stored to maintain integrity during testing.
4.2 Testing Methods
4.2.1 Inoculate samples with specified challenge organisms to simulate microbial contamination.
4.2.2 Incubate samples under controlled conditions to evaluate preservative efficacy over time.
4.3 Evaluation of Results
4.3.1 Monitor samples for microbial growth and assess effectiveness of preservatives.
4.3.2 Compare test results against acceptance criteria for preservative efficacy.
4.4 Documentation
4.4.1 Record preservative efficacy testing procedures, including sample preparation methods and testing conditions.
4.4.2 Document testing results, deviations observed, and any corrective actions taken.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure

6) Documents, if any

Preservative efficacy testing protocols, test records, microbial challenge study reports, and batch release certificates should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for preservative efficacy testing requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0