Propellant Handling Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for the safe handling and use of propellants 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 propellants within the MDI production facility, including production operators, chemical engineers, and safety officers.

3) Responsibilities

The responsibilities for this SOP include handling propellants safely, monitoring storage conditions, conducting risk assessments, and ensuring compliance with safety protocols. Specific roles include:
Production Operators: Handle and transfer propellants according to established procedures.
Chemical Engineers: Assess propellant compatibility and conduct risk assessments.
Safety Officers: Monitor safety protocols and provide training on propellant handling procedures.

4) Procedure

4.1 Propellant Storage and Handling
4.1.1 Store propellants in designated areas under controlled temperature and humidity conditions.
4.1.2 Use appropriate PPE (Personal Protective Equipment) during propellant handling operations.
4.2 Propellant Transfer
4.2.1 Transfer propellants using approved equipment and methods to minimize exposure and risk.
4.2.2 Conduct transfer operations in well-ventilated areas with adequate containment measures.
4.3 Emergency Procedures
4.3.1 Establish emergency response procedures for propellant spills, leaks, or accidents.
4.3.2 Train personnel on emergency response protocols and evacuation procedures.
4.4 Documentation
4.4.1 Maintain records of propellant handling procedures, including safety inspections and incident reports.
4.4.2 Document training records for personnel involved in propellant handling activities.

5) Abbreviations, if any

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

6) Documents, if any

Propellant handling protocols, safety data sheets (SDS) for propellants, 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 propellant handling and safety requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0