Validate and Maintain
Incubator validation: URS and IQ/OQ
Validating an incubator 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, CO2 Concentration Uniformity Study and Door Recovery Study.
An incubator keeps cell or microbial cultures at controlled temperature, CO2, O2 or humidity (CO2 incubator, microbiological incubator, shaking incubator). 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 an incubator starts from 21 requirements in 7 groups. You choose which apply and set each value. A few from each group are below.
Operating parameters3
- Temperature range
- CO₂ concentration range
- Maximum operating pressure
Capacity & dimensions3
- Internal volume
- Shelf load capacity
- Maximum shelf quantity
Design & construction4
- Incubator type
- Door type
- Number of doors
- and 1 more
Control & interface4
- System control type
- CO₂ control
- Humidity control
- and 1 more
Alarms & monitoring3
- Alarm capability
- Alarm types
- Remote alarm capability
Utilities & installation2
- Supply voltage
- Maximum amperage draw
Operating environment2
- Ambient temperature range
- Ambient humidity range
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
- CO2 Concentration Uniformity Study
- Door Recovery Study
- and 8 more
Regulations that can apply
ValDoc's library holds 8 regulations from US and EU sources that can apply to an incubator 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 4 plans for an incubator, 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
Incubator Temperature and CO2 Calibration
Calibration
Every 1 month
Incubator CO2 Verification Against a Reference Analyzer
Calibration
Every 1 year
Incubator Humidity and Alarm Calibration
PM
Every 1 year
Incubator Chamber and Mechanical 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
- Controlled Temperature Units
- 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.