Cleanroom Calibration and Validation Procedures Workflow

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1. Download the Workflow as PDF for Free and and implement the steps yourself.
2. Use the Workflow directly within the Mobile2b Platform to optimize your business processes.

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Cleanroom Calibration and Validation Procedures Workflow

1. Pre-Validation Activities
   • Review and approval of cleanroom design and layout
   • Cleaning and disinfection of the cleanroom
   • Verification of equipment and supplies
2. Equipment Calibration
   • Calibration of sensitive equipment, such as temperature and humidity control systems
   • Verification of cleanroom air flow rates and filter integrity
3. Cleanroom Air Quality Monitoring
   • Placement of air quality monitors throughout the cleanroom
   • Continuous monitoring of airborne particles and other contaminants
4. Visual Inspection and Cleaning
   • Thorough visual inspection of the cleanroom and equipment
   • Cleaning and disinfection of surfaces and equipment
5. Microbiological Testing
   • Collection of samples from the cleanroom environment
   • Analysis of microbial contamination levels
6. Documentation and Verification
   • Review and verification of calibration and validation data
   • Update of records and reports
7. Post-Validation Activities
   • Maintenance and upkeep of the cleanroom and equipment
   • Regular re-validation of the cleanroom to ensure continued compliance with standards

Implementing a Cleanroom Calibration and Validation Procedures Workflow can benefit your organization in several ways:

• Ensures accuracy and reliability of equipment and instruments within the cleanroom environment
• Improves compliance with regulatory requirements such as FDA, ISO, and cGMP guidelines
• Enhances data integrity and quality through standardized procedures and documentation
• Reduces risks associated with instrument drift or calibration errors that can impact product quality and patient safety
• Facilitates efficient maintenance and troubleshooting of equipment
• Supports a culture of quality and continuous improvement within the organization

1. Document Control
2. Scope Definition
3. Equipment Selection
4. Cleaning and Preparation
5. Instrument Installation
6. Verification and Testing
7. Performance Qualification (PQ)
8. Certification and Recordation
9. Corrective Action/Preventative Action (CAPA) Handling