Standard Operating Procedure for Equipment Shutdown and Restart Procedures
1) Purpose
The purpose of this SOP is to establish procedures for the safe and efficient shutdown and restart of equipment used in the manufacturing of dental dosage forms to prevent damage and ensure operational readiness.
2) Scope
This SOP applies to all equipment used in the production of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for executing equipment shutdown and restart procedures. The Maintenance Department is responsible for verifying equipment condition and readiness.
4) Procedure
4.1 Shutdown Procedures
4.1.1 Notify all relevant personnel about the intention to shut down the equipment.
4.1.2 Follow equipment-specific shutdown procedures provided by the manufacturer.
4.1.3 Ensure all product materials are properly disposed of or stored according to procedure.
4.2 Equipment Inspection and Preparation
4.2.1 Inspect equipment for any abnormalities or signs of wear and tear.
4.2.2 Perform necessary cleaning and sanitization of equipment parts as per standard operating procedures.
4.3 Restart Procedures
4.3.1 Ensure all maintenance and cleaning activities are completed and documented.
4.3.2 Follow manufacturer’s recommended procedures for equipment startup.
4.3.3 Conduct functional checks and verify equipment readiness for production.
4.4 Safety Checks
4.4.1 Verify safety features such as emergency stops and alarms are functional.
4.4.2 Conduct operational checks under controlled conditions to ensure equipment operates as expected.
4.5 Documentation
4.5.1 Maintain records of equipment shutdown and restart activities, including checklists, inspection reports, and any deviations encountered.
4.5.2 Update equipment logbooks and notify relevant departments of equipment status.
5) Abbreviations, if any
SOP – Standard Operating Procedure
6) Documents, if any
Equipment Shutdown and Restart Checklist
Maintenance and Cleaning Records
Equipment Logbook Entries
7) Reference, if any
Equipment Manufacturer’s Manuals
Internal Standard Operating Procedures (SOPs)
8) SOP Version
Version 1.0