Operation Start


CryoStart Specifications
Commissioning concept for systems with liquid nitrogen


Description
GMP/GLP-compliant commissioning concept for systems with liquid nitrogen, which meets specified customer requirements and contains the necessary documentation required for the proof of GMP/GLP-compliant storage of biological material under nitrogen cold.


Procedure

  • Unpacking and setting up containers at the operating site
  • Assembly and function test of sensors, controllers and power supply
  • Calibration of the temperature sensors with calibration certificate
  • Parameterize the controllers and sensors with setting log
  • Commissioning of all nitrogen supply lines with leak test
  • Interior cleaning of containers and storage systems for commissioning
  • Cooling/cold run of the system
  • Functional and safety briefing of the operating personnel

The commissioning, the results of the functional tests as well as the introduction/briefing are documented in detailed checklists and protocols.

Options

  • Implementation of IQ/OQ according to customers validation documents
  • Issuing of the IQ-Documentation
  • Issuing of the OQ-Documentation