Validate and Maintain
Vacuum pump validation: URS and IQ/OQ
Validating a vacuum pump 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 Maximum Vacuum Verification, Pump-Down Time Verification and Vacuum Leak Rate Verification.
Diaphragm, rotary vane, scroll or other pumps that generate vacuum. 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 vacuum pump starts from 14 requirements in 7 groups. You choose which apply and set each value. A few from each group are below.
Operating parameters1
- Ultimate vacuum
Performance1
- Applicable use
Design & construction6
- Vacuum equipment type
- Pump technology
- Oil requirement
- and 3 more
Control & interface1
- Vacuum control mode
Utilities & installation3
- Supply voltage
- Maximum amperage requirement
- Cooling method
Operating environment1
- Maximum noise level
Maintenance & serviceability1
- Oil capacity
What the IOQ tests
ValDoc's starting protocol has 15 test cases: 9 installation and 6 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 qualification6
- Maximum Vacuum Verification
- Pump-Down Time Verification
- Vacuum Leak Rate Verification
- and 3 more
Regulations that can apply
ValDoc's library holds 9 regulations from US and EU sources that can apply to a vacuum pump 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 3 plans for a vacuum pump, 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.
PM
Every 1 year
Vacuum Performance Verification
PM
Every 6 months
Vacuum Pump Preventive Maintenance
Calibration
Every 1 year
Vacuum Gauge 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
- Cryogenic Systems
- Stability Chambers
- Sterilization Equipment
- Transport Systems
- Label Printers
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.