Validate and Maintain
Cryogenic system validation: URS and IQ/OQ
Validating a cryogenic system means writing a URS for its intended use, assessing the risks, then running an IOQ. The IQ confirms it was installed as specified, and the OQ proves it performs, with tests such as Temperature Profile Study, LN₂ Consumption / Hold Time Study and Lid Open Recovery Test.
A cryogenic system stores material at cryogenic temperatures with liquid nitrogen (LN2 dewar, vapour-phase or liquid-phase storage tank, LN2 freezer). ValDoc drafts the URS, risk assessment, IOQ and SOP from the intended use you state, runs the IOQ at the bench and keeps its maintenance on the same record. It does not draft the PQ, which depends on your process. You write that as your own Protocol.
Last updated
Thirty minutes. Bring one piece of equipment.
What the URS specifies
ValDoc's URS for a cryogenic system starts from 16 requirements in 8 groups. You choose which apply and set each value. A few from each group are below.
Operating parameters1
- Temperature range
Performance1
- Storage phase
Capacity & dimensions1
- LN₂ capacity
Design & construction4
- Equipment type
- Cooling method
- Insulation type
- and 1 more
Control & interface1
- Data logging
Alarms & monitoring4
- Alarm capability
- Alarm types
- Remote alarm capability
- and 1 more
Utilities & installation2
- Supply voltage
- Maximum amperage draw
Operating environment2
- Ambient temperature range
- Ambient humidity range
What the IOQ tests
ValDoc's starting protocol has 19 test cases: 9 installation and 10 operational. A few from each phase are below, and your team reviews and edits every test before the protocol is approved.
Installation qualification9
- Settings Verification
- Equipment Condition Check
- System Information & Nameplate Verification
- and 6 more
Operational qualification10
- Temperature Profile Study
- LN₂ Consumption / Hold Time Study
- Lid Open Recovery Test
- and 7 more
Regulations that can apply
ValDoc's library holds 8 regulations from US and EU sources that can apply to a cryogenic system URS, including 21 CFR Part 11, EudraLex Volume 4, Annex 11 and EudraLex Volume 4, Annex 15. Which of them apply depends on its intended use.
United States4
European Union4
Maintenance and calibration
Maintain proposes 3 plans for a cryogenic system, and you confirm each cadence against the manual and your SOP. Each unit gets its own schedule and history, on the same record as its qualification. Maintain also offers 4 plans any family can use, such as Electrical Safety Inspection.
Calibration
Every 1 year
Cryogenic System Temperature and Level Sensor Calibration
PM
Every 1 year
Cryogenic System Vacuum, Valve, and Transfer Line Preventive Maintenance
Calibration
Every 1 year
Cryogenic Area Oxygen Deficiency Monitor Calibration
Other equipment
ValDoc can still support equipment that is not on this list. Adding the equipment families a lab needs is part of onboarding, so tell us what you run.
- Biosafety Cabinets
- Controlled Temperature Units
- Incubators
- Centrifuges
- Environmental Monitoring
- Thermal Sealing and Welding Systems
- Weighing Devices
- Liquid Handling Equipment
- Stability Chambers
- Sterilization Equipment
- Transport Systems
- Label Printers
- Vacuum Pumps
See your own equipment in ValDoc.
Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.
Thirty minutes. Bring one piece of equipment.