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 the formulation.
4.3 Safety Precautions
4.3.1 Wear appropriate PPE (Personal Protective Equipment) during solvent handling operations.
4.3.2 Implement fire safety measures and emergency response procedures for solvent spills or accidents.
4.4 Documentation
4.4.1 Maintain records of solvent handling procedures, including safety inspections and incident reports.
4.4.2 Document training records for personnel involved in solvent handling activities.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment

6) Documents, if any

Solvent handling protocols, safety data sheets (SDS) for solvents, risk assessment reports, and training records should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and OSHA for solvent handling and safety requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0