Standard Operating Procedure for Equipment Decommissioning
1) Purpose
The purpose of this SOP is to outline procedures for the decommissioning of equipment used in the manufacturing of dental dosage forms, ensuring that equipment is safely removed from service, properly disposed of, and documented in compliance with regulatory requirements.
2) Scope
This SOP applies to all equipment used in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry, where equipment decommissioning is necessary due to obsolescence, replacement, or regulatory reasons.
3) Responsibilities
The Engineering Department is responsible for coordinating and overseeing equipment decommissioning activities. Quality Assurance (QA) personnel are responsible for reviewing and approving decommissioning protocols and documentation. Production personnel are responsible for ensuring equipment readiness for decommissioning.
4) Procedure
4.1 Preparation for Decommissioning
4.1.1 Identify equipment to be decommissioned based on operational status, regulatory requirements, and company policies.
4.1.2 Notify relevant stakeholders, including QA, production, and maintenance departments, about the planned decommissioning activities.
4.2 Decommissioning Process
4.2.1 Disconnect and isolate the equipment from all utilities, including electrical, water, and air supplies.
4.2.2 Drain and purge equipment of all residual materials and substances, following approved procedures for waste disposal.
4.2.3 Remove and label all critical components, parts, and accessories for potential reuse or disposal.
4.3 Cleaning and Decontamination
4.3.1 Clean and decontaminate equipment surfaces using approved cleaning agents and disinfectants to ensure removal of contaminants and residues.
4.3.2 Perform environmental monitoring and sampling, if required, to verify cleanliness and decontamination efficacy.
4.4 Documentation and Disposal
4.4.1 Complete decommissioning documentation, including decommissioning reports, checklists, and disposal certificates.
4.4.2 Dispose of decommissioned equipment components, parts, and accessories according to environmental regulations and company policies.
4.5 Equipment Disposal Verification
4.5.1 Verify proper disposal of equipment and related materials through documentation review and inspection.
4.5.2 Obtain QA approval for decommissioning reports and disposal certificates before final closure of decommissioning activities.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Decommissioning Plan
Decommissioning Checklist
Decommissioning Report
Disposal Certificates
7) Reference, if any
Regulatory guidelines for equipment decommissioning
Company-specific decommissioning policies and procedures
8) SOP Version
Version 1.0
