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The turnover package (TOP) that is available for each module is a comprehensive collection of information required to validate the system. Standard elements of the package include:

• Drawing section, including General Arrangement, P&ID, vessel drawings and weld maps
• Detailed process design package
• Detailed automation design package
• Valve, instrumentation and equipment manuals and certificates
• Qualification package, including material certification, welding documentation, etc.
• Full weld documentation to meet cGMP requirements
• Comprehensive Factory Acceptance Test documentation

A great share of our expertise includes full compliance with the regulatory demands of the FDA in the Life Science industry including cGMP and BPE standards. As such, each of our systems can easily be designed and built to include:

• Complete design and fabrication life cycle controls and traceability
• Automation systems developed, built and tested to be GAMP compliant
• Material certifications and test reports on all process contact components
Fabrication testing including boroscope weld records and an option for videotape

Other features available include:

• Systems Manuals
• Maintenance programs
• Installation
• Start-up
• Training
• System Spare Parts


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