Bio-Pharm: Documentation

documentation

Detailed Turnover Packages

Documentation is absolutely critical to comply with current good manufacturing practices (cGMP), which require proof that the manufacturing process repeatedly generates pharmaceutical products that meet attributes relating to identity, strength, quality, purity and potency.

The Sani-Matic turnover package is extremely detailed and designed to minimize your validation costs. Our dedicated team of documentation specialists ensures the documentation required to validate our cleaning equipment is provided with every purchase.

An overview of our comprehensive turnover package is listed below, including optional documentation that is priced individually, allowing you to choose the items that benefit your validation efforts.

Have a question regarding the documentation offering?  Give us a call and speak to our experienced sales, documentation and engineering teams regarding the right validation package for your process.


What Our Customers Have to Say About the Sani-Matic Turnover Package
“Please send us the digital version of your full turnover package so we can give it to our other vendors as an example of what we want to see.”

Global Provider of Sterile Solutions

Standard Documentation
  • Operation and maintenance manuals
  • Recommended spare parts list
  • Instrument lists (serial numbers, model numbers, calibration certificates, ranges and accuracy)
  • Vendor-provided instrumentation calibration procedures
  • Performance data (pump, heat exchanger, etc.)
  • Material Certificates (MTR's, ferrite test, letters of compliance)
  • Surface finish report
  • Drain report
  • Weld qualification and inspection records
  • Inspection test results, reports and certificates
  • ASME data
  • Component catalog cut sheets
  • As-built assembly drawings
  • As-built process and instrumentation diagrams (P&ID)
  • As-built electrical drawings
  • PLC and HMI application files
  • I/O list
Optional Documentation
  • Functional Specification (FS)
  • Configuration Specification (CS)
  • Factory Acceptance Test (FAT)
  • Site Acceptance Test (SAT)
  • Installation and Operation Qualification (IQ/OQ)
  • Traceability Matrix
  • ISA Data Sheets
  • Digital weld video record (Borescope)
  • Hydrostatic test certificate
  • Cleaning and passivation certificate
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