Validate and Maintain
Biosafety cabinet validation: URS and IQ/OQ
Validating a biosafety cabinet 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 Downflow Velocity Uniformity Study, Inflow Velocity & Containment Airflow Study and HEPA Filter Integrity & In-Situ Leak Test (Supply & Exhaust).
A ventilated enclosure with HEPA-filtered airflow that protects the operator, product or both during aseptic work (Class I, II or III, laminar flow hood). 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 biosafety cabinet starts from 20 requirements in 7 groups. You choose which apply and set each value. A few from each group are below.
Performance2
- Inflow velocity
- Downflow velocity
Capacity & dimensions3
- Cabinet width
- Cabinet depth
- Cabinet height
Design & construction5
- Cabinet class and type
- Airflow type
- HEPA filter type
- and 2 more
Control & interface2
- Sash type
- Operating sash height
Alarms & monitoring2
- Remote alarm capability
- Sash height alarm
Utilities & installation2
- Supply voltage
- Maximum amperage draw
Operating environment4
- Noise level
- Work-zone lighting intensity
- Ambient temperature range
- and 1 more
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
- Equipment Condition & Physical Installation Check
- System Information & Nameplate Verification
- Standard Operating Procedures Verification
- and 6 more
Operational qualification10
- Downflow Velocity Uniformity Study
- Inflow Velocity & Containment Airflow Study
- HEPA Filter Integrity & In-Situ Leak Test (Supply & Exhaust)
- and 7 more
Regulations that can apply
ValDoc's library holds 9 regulations from US and EU sources that can apply to a biosafety cabinet 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 2 plans for a biosafety cabinet, 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
BSC Airflow, HEPA Integrity, and Alarm Verification Certification
PM
Every 1 year
BSC Mechanical and Electrical 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.
- 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
- 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.