Validate and Maintain
Controlled temperature unit validation: URS and IQ/OQ
Validating a controlled temperature unit 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 Empty Chamber Temperature Uniformity Study, Open Door Test and Power Failure Test.
A refrigerator, freezer (including -80 °C ultra-low), cold room or ambient cabinet that stores GMP materials at a set temperature. 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.
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Thirty minutes. Bring one piece of equipment.
What the URS specifies
ValDoc's URS for a controlled temperature unit starts from 25 requirements in 9 groups. You choose which apply and set each value. A few from each group are below.
Operating parameters1
- Temperature range
Performance4
- Startup stabilization time
- Evaporator and condenser efficiency
- Fan speed and airflow pattern
- and 1 more
Capacity & dimensions2
- Internal volume
- Shelf load capacity
Design & construction5
- Number of doors
- Compressor type
- Refrigeration system present
- and 2 more
Control & interface3
- Temperature control type
- Controller type
- Temperature sensor type
Alarms & monitoring2
- Alarm types
- Remote alarm capability
Utilities & installation3
- Supply voltage
- Maximum amperage draw
- Installation clearance
Operating environment3
- Ambient temperature range
- Ambient humidity range
- Altitude-dependent refrigerant behavior
Maintenance & serviceability2
- Defrost control
- Defrost method
What the IOQ tests
ValDoc's starting protocol has 20 test cases: 9 installation and 11 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 qualification11
- Empty Chamber Temperature Uniformity Study
- Open Door Test
- Power Failure Test
- and 8 more
Regulations that can apply
ValDoc's library holds 9 regulations from US and EU sources that can apply to a controlled temperature unit 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 Union5
Maintenance and calibration
Maintain proposes 2 plans for a controlled temperature unit, 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 6 months
CTU Control Probe Calibration
PM
Every 1 year
CTU Refrigeration and Alarm Preventive Maintenance
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
- Incubators
- Centrifuges
- Environmental Monitoring
- Thermal Sealing and Welding Systems
- Weighing Devices
- Liquid Handling Equipment
- Cryogenic Systems
- 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.