ValidationWe qualify the whole solution — machine, tool, material and the pack itself — against our 40+ page protocol. FAT, IQ, OQ and PQ, documented so you can prove it works and keep it proven.
Prove the whole solution — not just the parts
A validated machine that runs an unproven tool on an untested material is not a validated pack. We qualify the integrated solution end to end — and document the evidence so it holds up to an audit.
Because the machine, tool and material come from one source, they are qualified as one system: FAT before it ships, IQ and OQ on your site, PQ in real production — with the pack itself stress-tested to ISO 11607. One protocol, one report, one accountable owner.
FAT → IQ → OQ → PQ
Four stages, each answering a different question — from “does it work before it ships?” to “does it perform, run after run, in your plant?”
Machine and tool are run together on your material at our works — function, safety, and sample packs verified against the agreed specification. You sign off before it leaves us, so nothing is discovered on installation day.
Machine, tool, utilities and documentation are verified as installed to specification — correct components, connections, calibration and manuals in place. The baseline the rest of validation is built on.
Temperature, pressure, dwell, cycle and alarms are tested across the operating window — including the edges — to establish and challenge the process window. This is where the safe operating limits are proven.
Extended production runs at the set recipe, in real conditions, prove the solution makes a consistent, conforming pack — batch after batch. The packs are stress-tested to confirm the sterile barrier holds.
Four things, qualified as one
The strength of an integrated solution is that nothing is validated in isolation — each part is qualified in the context of the others.
Installed, calibrated and running to spec — parameters, cycles and alarms behaving across the range.
Forms, seals and cuts to drawing — the right tool, correctly fitted, producing dimensionally correct packs.
Forming film and lidding confirmed compatible with the process, the product and the sterilisation method.
The finished pack, tested to prove the sterile barrier survives sealing, handling, ageing and transport.
Testing the pack to ISO 11607
ISO 11607 governs sterile barrier packaging in two parts — Part 1 for the material and system, Part 2 for the forming and sealing process (the IQ/OQ/PQ above). The pack is proven with a risk-based programme of destructive and non-destructive tests.
Force to peel the seal apart — strong enough to protect, controlled enough to open cleanly.
ASTM F88Inflates the pack to find the weakest point; creep holds sub-burst pressure to catch slow failures.
ASTM F1140 / F2054A dye reveals channels or pinholes in the seal — a pass/fail check of barrier integrity.
ASTM F1929Submerged and pressurised, a leaking pack streams bubbles — allowing 100% inspection without destroying product.
ASTM F2096Ageing at elevated temperature (backed by real-time) establishes and confirms the claimed shelf life.
ASTM F1980Vibration, shock and stacking that mimic real shipping — the pack must arrive intact, not just leave intact.
ASTM D4169 / ISTAThe exact programme is risk-based — selected per device class, material and sterilisation method. Integrity tests double as in-process checks once the process is qualified.
A 40+ page protocol, followed to the letter
Validation is only as good as the document behind it. Every job runs on the same structured protocol — so nothing is skipped, every result has an acceptance criterion, and the evidence reads the same way every time.
What you get
Re-validation is triggered by any process or material change, or a negative quality trend. Between times, periodic in-process checks confirm the process is still in control.
Tell us what needs qualifying — a new line, an existing one, or a change — and we scope the protocol.
Have a URS or existing protocol? Attach it
Validation FAQ
Do I have to buy the machine from you to be validated?+
The integrated validation is strongest when machine, tool and material are ours — that’s where FAT and single-owner accountability come from. We can also validate the tool, material and pack on an existing line; talk to us about scope.
What’s the difference between FAT and IQ?+
FAT happens at our factory before shipment — proving the machine and tool work before they move. IQ happens on your site — proving they were installed correctly. FAT de-risks installation; IQ is the on-site baseline for OQ and PQ.
Which standards do you validate to?+
Packaging is validated to ISO 11607 Parts 1 and 2, using ASTM methods such as F88 (seal strength), F1140/F2054 (burst), F1929 (dye penetration), F2096 (bubble leak), F1980 (ageing) and D4169/ISTA (transport). The exact set is risk-based for your device.
When do I need to re-validate?+
After any change to the process or material, or if quality trends turn negative — and a series of small changes can add up to a trigger too. The re-validation plan we deliver spells out exactly what prompts it and what it covers.
How does validation connect to traceability?+
Validation sets the proven recipe and limits; the Traceability Pack then logs every run against them — parameters, material, tool and operator — so you can show each batch was made inside its validated window.
The full service, end to end
Design, validation and traceability — three services that hand off cleanly from one to the next, all built on the same integrated solution.
From brief to a tool-ready blister or tray.
Open →FAT, IQ, OQ & PQ of the whole solution.
You are hereMachine, tool, material and user — all logged.
Open →