Standard Operating Procedure for Equipment Decontamination
1) Purpose
The purpose of this SOP is to establish procedures for the effective decontamination of equipment used in the manufacturing of dental dosage forms to prevent cross-contamination and ensure product safety.
2) Scope
This SOP applies to all equipment and surfaces involved in the production of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for executing equipment decontamination procedures. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.
4) Procedure
4.1 Pre-Decontamination Preparation
4.1.1 Notify all relevant personnel about the upcoming decontamination process.
4.1.2 Gather necessary materials and equipment for decontamination, including approved cleaning agents and PPE.
4.1.3 Ensure equipment to be decontaminated is properly identified and isolated from production areas.
4.2 Decontamination Process
4.2.1 Disassemble equipment components as per manufacturer’s instructions, if applicable.
4.2.2 Apply approved decontamination agents and follow specified contact times and concentrations.
4.2.3 Use appropriate cleaning methods such as scrubbing, wiping, or rinsing to ensure thorough decontamination.
4.3 Inspection and Verification
4.3.1 Inspect equipment surfaces visually to ensure all visible residues are removed.
4.3.2 Perform swab sampling and testing as per cleaning validation protocols to verify effectiveness of decontamination.
4.4 Reassembly and Post-Decontamination Procedures
4.4.1 Reassemble equipment components and ensure proper alignment and functionality.
4.4.2 Perform final inspection to confirm equipment readiness for use.
4.5 Documentation
4.5.1 Document all decontamination activities, including cleaning records, inspection results, and any deviations encountered.
4.5.2 Update equipment logbooks and maintenance records with decontamination details.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Decontamination Checklist
Cleaning Validation Reports
Equipment Logbook Entries
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
Internal Standard Operating Procedures (SOPs)
8) SOP Version
Version 1.0
