Validate and Maintain
Thermal sealer or welder validation: URS and IQ/OQ
Validating a thermal sealer or welder 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 Seal Integrity, Uniformity, and Reproducibility Study, Tube Sealer Leak Integrity Challenge Test and Tube Welder Visual Weld Integrity & Functional Opening Verification.
Tube sealers, sterile tube welders, bag sealers and microplate heat sealers. 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 thermal sealer or welder starts from 17 requirements in 8 groups. You choose which apply and set each value. A few from each group are below.
Operating parameters2
- Sealing temperature range
- Sealing pressure
Performance2
- Application type
- Material compatibility
Capacity & dimensions3
- Unit width
- Unit depth
- Unit height
Design & construction2
- Equipment type
- Heating method
Control & interface4
- Temperature control type
- Timer
- Programmable settings
- and 1 more
Alarms & monitoring1
- Alarm capability
Utilities & installation2
- Supply voltage
- Maximum amperage draw
Operating environment1
- Safety features
What the IOQ tests
ValDoc's starting protocol has 16 test cases: 9 installation and 7 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 qualification7
- Seal Integrity, Uniformity, and Reproducibility Study
- Tube Sealer Leak Integrity Challenge Test
- Tube Welder Visual Weld Integrity & Functional Opening Verification
- and 4 more
Regulations that can apply
ValDoc's library holds 9 regulations from US and EU sources that can apply to a thermal sealer or welder 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 thermal sealer or welder, 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
Thermal Sealer Temperature, Time, and Pressure Calibration
PM
Every 1 year
Thermal Sealer Mechanical and Blade Assembly Preventive Maintenance
PM
Every 1 year
Thermal Sealer Weld Integrity 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
- 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.