Commissioning concept for systems with liquid nitrogen
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.
- 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.
- Implementation of IQ/OQ according to customers validation documents
- Issuing of the IQ-Documentation
- Issuing of the OQ-Documentation