Spirax Ultrapure has the expertise you need when it comes to Validation. All our equipment and systems come with a standard documentation package. Spirax Ultrapure equipment has never failed a FDA validation audit. This is due to our in-depth knowledge in current good manufacturing practices. If you need it validated nobody can offer a better documentation package than us. Below a partial list of validation documentation that is regularly provided. Contact Us for more Information on our Validation Documentation.
Installation Qualification
- Pipe and Instrumentation Diagrams
- General Arrangement Drawings
- Controls Schematics
- Mill Certs and/or C of C for Product Contact Materials
- Certified Passivation or Electropolish Procedures
- Orbital Weld Logs & Inspection Reports
- Video Borescope Weld Inspections
- ASME® Vessel Certifications
- Hydrostatic Pressure Test Results
- NIST Traceable Instrumentation Calibration
- Operating & Maintenance Instructions
- Manufacturers Component Manuals
- Automation Detailed Design Specifications (per GAMP & CFR xx1 Sec. 11)
- Installation Qualification Protocol Templates
Operational Qualifications
- Factory Acceptance Test Results
- Site Acceptance Test Results
- Product Conductivity Testing (during FAT)
- Endotoxin Challenge Test Results
- Operational Qualification Protocol Templates
- PLC & HMI Inspection Results
Quality Assurance
- ASME® Section VIII
- cGMP Compliant Quality Program
- 100% Incoming Material Quarantine and Inspection
- ASME® Certified Welders and weld Procedures
- GAMP4 Compliant Automation Procedures
- UL Certified Control Panel Manufacturing
- Non-Destructive Testing including Video Borescope
- Dye Penetration and Radiography
- Profilometer Surface Finish Testing
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