Solvent Handling Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for the safe handling and use of solvents in metered-dose inhaler (MDI) production to ensure operator safety, product quality, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the handling and use of solvents within the MDI production facility, including production operators, chemical engineers, and safety officers.

3) Responsibilities

The responsibilities for this SOP include handling solvents safely, monitoring usage levels, conducting risk assessments, and ensuring compliance with safety protocols. Specific roles include:
Production Operators: Handle and dispense solvents according to approved procedures.
Chemical Engineers: Assess solvent compatibility and conduct risk assessments.
Safety Officers: Monitor safety protocols and provide training on solvent handling procedures.

4) Procedure

4.1 Solvent Storage and Handling
4.1.1 Store solvents in designated areas with appropriate ventilation and safety equipment.
4.1.2 Use compatible containers and dispensing equipment to minimize exposure and spills.
4.2 Solvent Addition to Formulations
4.2.1 Add solvents to MDI formulations using calibrated equipment and controlled dispensing methods.
4.2.2 Ensure thorough mixing and dispersion of solvents within