Standard Operating Procedure for Cleaning of Equipment Used for Aerosol Production
1) Purpose
The purpose of this SOP is to outline the procedures for cleaning equipment used in the production of aerosols in the pharmaceutical industry. This ensures the removal of product residues, contaminants, and microbial load to prevent cross-contamination and maintain product quality.
2) Scope
This SOP applies to the cleaning operations conducted in the manufacturing area at [Company Name], specifically for equipment used in aerosol production processes.
3) Responsibilities
Production Supervisor: Oversees cleaning procedures and ensures adherence to SOP.
Cleaning Operators: Perform cleaning tasks according to established procedures.
Quality Assurance (QA) Personnel: Verify cleaning effectiveness and compliance.
4) Procedure
4.1 Pre-Cleaning Preparation:
4.1.1 Notify production and schedule equipment cleaning after completion of production.
4.1.2 Obtain cleaning materials and tools required for the process.
4.2 Disassembly (if applicable):
4.2.1 Disassemble equipment parts as per the cleaning procedure.
4.2.2 Handle disassembled parts with care to prevent damage.
4.3 Cleaning Process:
4.3.1 Rinse equipment surfaces with water or appropriate cleaning solvent.
4.3.2 Use approved cleaning agents and detergents as specified in the cleaning procedure.
4.4 Sanitization (if applicable):
4.4.1 Apply sanitizing agents to critical surfaces to ensure microbial control.
4.4.2 Follow contact time requirements for
4.5 Rinse and Inspection:
4.5.1 Rinse equipment thoroughly with purified water to remove cleaning residues.
4.5.2 Inspect equipment surfaces visually for cleanliness and absence of residues.
4.6 Reassembly and Verification:
4.6.1 Reassemble equipment parts carefully according to assembly diagrams or procedures.
4.6.2 Verify correct assembly and functionality of equipment before returning to production.
4.7 Documentation:
4.7.1 Record cleaning details, including cleaning agents used, cleaning duration, and personnel involved.
4.7.2 Document inspection results and any deviations encountered during the cleaning process.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Cleaning Records
Equipment Cleaning Validation Reports
Batch Manufacturing Record (BMR)
7) Reference, if any
FDA Guidelines for Cleaning Validation
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0