Validate and Maintain
Centrifuge validation: URS and IQ/OQ
Validating a centrifuge 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 RPM/RCF Accuracy Study, Temperature Control Study and Timer Accuracy Study.
A centrifuge separates sample components by spinning them (benchtop, floor-standing, refrigerated or micro centrifuge, and their rotors). 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 centrifuge starts from 22 requirements in 8 groups. You choose which apply and set each value. A few from each group are below.
Operating parameters3
- Maximum speed
- Maximum relative centrifugal force
- Temperature range
Performance3
- Acceleration time
- Deceleration time
- Imbalance tolerance
Capacity & dimensions1
- Maximum capacity
Design & construction4
- Centrifuge type
- Refrigeration
- Rotor type compatibility
- and 1 more
Control & interface4
- Speed control type
- Programmable programs
- Timer
- and 1 more
Alarms & monitoring3
- Imbalance detection alarm
- Electrical abnormality alarm
- Temperature sensor alarm
Utilities & installation2
- Supply voltage
- Maximum amperage draw
Operating environment2
- Lid interlock
- Over-speed protection
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
- RPM/RCF Accuracy Study
- Temperature Control Study
- Timer Accuracy Study
- and 7 more
Regulations that can apply
ValDoc's library holds 8 regulations from US and EU sources that can apply to a centrifuge 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 centrifuge, 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
Centrifuge Speed, Timer, and Temperature Calibration
PM
Every 1 year
Centrifuge Rotor and Safety System Preventive Maintenance
Calibration
Every 6 months
Centrifuge Speed, Timer, and Temperature Calibration (Critical Use)
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
- 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.