Validate and Maintain
Stability chamber validation: URS and IQ/OQ
Validating a stability chamber 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, Empty Chamber Humidity Uniformity Study and Open Door Recovery Test.
A stability chamber holds temperature and relative humidity for ICH stability testing or photostability (reach-in or walk-in climatic chamber). 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 stability chamber starts from 29 requirements in 7 groups. You choose which apply and set each value. A few from each group are below.
Operating parameters2
- Temperature range
- Humidity range
Capacity & dimensions3
- Chamber capacity
- Number of shelves
- Maximum load capacity
Design & construction8
- Chamber type
- Cooling type
- Humidification method
- and 5 more
Control & interface4
- Temperature control type
- Setpoint control features
- Data logging
- and 1 more
Alarms & monitoring4
- Alarm capability
- Alarm types
- Remote alarm capability
- and 1 more
Utilities & installation6
- Supply voltage
- Maximum amperage draw
- Installation clearance
- and 3 more
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
- Empty Chamber Humidity Uniformity Study
- Open Door Recovery Test
- and 8 more
Regulations that can apply
ValDoc's library holds 8 regulations from US and EU sources that can apply to a stability chamber 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 2 plans for a stability chamber, 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
Stability Chamber Temperature and Humidity Sensor Calibration
PM
Every 1 year
Stability Chamber HVAC 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
- Controlled Temperature Units
- Incubators
- Centrifuges
- Environmental Monitoring
- Thermal Sealing and Welding Systems
- Weighing Devices
- Liquid Handling Equipment
- Cryogenic Systems
- 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.