Thermo Scientific™ Sorvall™ X4 R Pro Cell Therapy Packages with IQ/OQ/PQ Field Services
Sorvall™ X4 R Pro CTS series Cell Therapy Package, containing Factory Acceptance Test Documentation, and IQ/OQ field servies help you set up the processes faster, stay compliant, support regulatory audits
Sorvall™ X4 R Pro CTS Centrifuges are designed to help you get your research done more quickly, consistently, and with powerful reliability. Factory Acceptance Test (FAT) documentation that contains regulatory certificates, recommended protocols and product specific factory documentation will support your timely and rapid validation process. Our field service solutions provided within the package offer extensive installation and operation qualifications to get you up and running faster.
Sorvall™ X4 R Pro CTS Centrifuges satisfy not only your need for an essential separation equipment, but also provide you necessary compliance documentation and validation services.
- Intuitive touch screen interface for faster programming
- Outstanding 4 L capacity with the TX-1000 rotor enabling rapid batch processing
- Run log data download in a non-altered PDF format through the USB port to streamline process traceability
- Scheduling features and preventative maintenance queues help reduce downtime to avoid delay of cell processing and impact on cell viability
- ClickSeal™ Biocontainment Lids help prevent contamination
- Compatible with common cGMP and cleanroom disinfecting procedures such as Steris VHP dry heat sterilization
- Factory acceptance test documentation contain multiple regulatory certificates (declaration of conformity (CE), CSA and QMS certificates, certificates of environmental status), suggested customer maintenance schedule and product-specific factory documentation (certificate of conformance, technical specifications, equipment drawings, Porton Down certificate from Public Health England)
- Our field service solutions offer extensive installation qualifications (unpacking, assembly, and installation) and operation qualifications (equipment operational tests, OQ limits, preparation of the system component information) to get you up and running faster.
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