Validate and Maintain
Sterilizer validation: URS and IQ/OQ
Validating a sterilizer 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 Distribution Study, Loaded Chamber Sterilization Cycle Study and Biological Indicator / Lethality Verification.
Autoclaves, steam sterilizers, dry-heat sterilizers and VHP or hydrogen peroxide decontamination systems. 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 sterilizer starts from 28 requirements in 7 groups. You choose which apply and set each value. A few from each group are below.
Operating parameters1
- Operating temperature range
Performance3
- Chamber pressure capability
- Vacuum capability
- Drying capability
Capacity & dimensions4
- Chamber volume
- Chamber width
- Chamber depth
- and 1 more
Design & construction6
- Equipment type
- Sterilization method
- Chamber type
- and 3 more
Control & interface7
- Controller type
- Cycle programmability
- Stored cycle programs
- and 4 more
Alarms & monitoring4
- Alarm capability
- Alarm types
- Alarm logic
- and 1 more
Utilities & installation3
- Utility connections
- Supply voltage
- Maximum amperage draw
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 Distribution Study
- Loaded Chamber Sterilization Cycle Study
- Biological Indicator / Lethality Verification
- and 8 more
Regulations that can apply
ValDoc's library holds 10 regulations from US and EU sources that can apply to a sterilizer 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 States5
European Union5
Maintenance and calibration
Maintain proposes 3 plans for a sterilizer, 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
Sterilizer Temperature and Pressure Calibration
PM
Every 1 year
Sterilizer Steam Quality and Mechanical Preventive Maintenance
PM
Every 1 year
Sterilizer Cycle Performance and Biological Indicator Verification
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
- 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.