Procedure for Preparing MDIs
1) Purpose
The purpose of this SOP is to outline the procedure for the preparation of metered-dose inhalers (MDIs) in the pharmaceutical industry, ensuring consistent quality and compliance with regulatory standards.
2) Scope
This SOP applies to all personnel involved in the preparation of MDIs at the manufacturing facility, including operators, supervisors, and quality control staff.
3) Responsibilities
The responsibilities for this SOP include ensuring that all steps are followed accurately and that all necessary documentation is completed. Specific roles include:
Operators: Execute the preparation steps as outlined.
Supervisors: Monitor the process and ensure compliance.
Quality Control: Verify and document each stage of the preparation process.
4) Procedure
4.1 Preparation of Raw Materials MDI: Metered-Dose Inhaler Batch manufacturing records, raw material specifications, and equipment logs should be maintained. Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for MDI preparation standards. Version 1.0
4.1.1 Verify the identity and quality of raw materials.
4.1.2 Weigh and measure raw materials as per the formulation requirements.
4.2 Mixing and Homogenization
4.2.1 Transfer the raw materials to the mixing vessel.
4.2.2 Homogenize the mixture to ensure uniform distribution of ingredients.
4.3 Filling Process
4.3.1 Sterilize the filling equipment before use.
4.3.2 Fill the homogenized mixture into the canisters.
4.4.1 Attach the valve to the canister and crimp it securely.
4.4.2 Seal the canister to prevent contamination.
4.5 Propellant Filling
4.5.1 Fill the canister with the appropriate propellant under controlled conditions.
4.6 Final Inspection
4.6.1 Inspect the filled MDIs for any defects or deviations.
4.6.2 Record the batch number and other relevant details for traceability.
5) Abbreviations, if any
6) Documents, if any
7) Reference, if any
8) SOP Version