A leak in a medical device is never a small problem. It can compromise sterility. It can cause dosing errors. It can trigger a recall. For manufacturers in the Netherlands, reliable leak testing is part of building products that clinicians and patients can trust.
ATEQ has designed leak testing equipment since 1975. Our instruments test catheters, fluid lines, connectors, housings and packaging on production lines worldwide. This guide explains the methods, the regulations and the key questions to ask when choosing a leak tester for medical production.
Why leak testing matters in Dutch medtech
The Netherlands has one of Europe’s most active medical technology sectors. Brainport Eindhoven and Health Valley in the east host manufacturers, contract producers and specialist suppliers serving hospitals across Europe.
These companies share three pressures: strict regulation, rising volumes and zero tolerance for field failures. Leak testing addresses all three. It verifies every part, it runs at production speed, and it produces records that auditors accept.
Regulations that drive leak testing
EU MDR (Regulation 2017/745): The Medical Device Regulation raised expectations for clinical evidence, post-market surveillance and technical documentation. If a device must be sealed, you need objective proof that it is.
ISO 13485: Where you cannot fully verify a process output by later inspection, the standard requires you to validate the process. Seal integrity is a classic example. A validated leak test, with defined parameters and recorded results, is how manufacturers meet this requirement.
ISO 80369: The small-bore connector standards include leakage requirements for connectors such as Luer fittings. Manufacturers of IV sets, syringes and catheters test against them routinely.
ISO 11607 and container closure integrity: Sterile barrier systems must maintain their integrity through to the point of use. For pharmaceutical packaging, USP <1207> favours deterministic test methods, such as vacuum decay, over probabilistic ones like dye ingress.
Leak testing methods for medical devices
No single method suits every part. The right choice depends on the part’s volume, material, target leak rate and cycle time.
Pressure decay: The part is pressurised with dry air and isolated. The instrument measures any drop in pressure over a set time. The method is simple, clean and repeatable, which makes it the workhorse of medical production. It suits catheters, tubing, valves and rigid housings.
Mass flow: The instrument measures the flow of air needed to maintain the test pressure. It is well suited to larger volumes and to parts where temperature effects would disturb a pressure decay reading.
Vacuum decay: The part or package sits in a sealed chamber under vacuum. Leaks show as a rise in chamber pressure. It is non-destructive, deterministic and recognised in ASTM F2338. It is the reference method for many packaging applications.
Tracer gas: For the smallest leak rates, a tracer gas such as helium offers higher sensitivity. It costs more per test, so it is best reserved for applications that genuinely require it.
Leak testing blister packaging
Blister packs protect tablets, capsules and small medical devices from moisture, oxygen and contamination. A single faulty pocket can ruin a batch.
The challenge: Blister packs combine many small cavities, thin films and fast packaging lines. Traditional blue dye and water bath tests are destructive, operator-dependent and slow. They also tell you little about the size of a leak.
The modern approach: Vacuum-based testing detects leaks in blister cards without destroying them. Results are numeric, repeatable and easy to trend. This makes validation simpler and gives quality teams data they can act on.
Porous lids need care: Many medical device blister trays use breathable lidding materials. A breathable lid lets gas through by design, so the test method and parameters must account for it. Discuss your packaging materials early when specifying equipment.
Choosing a leak tester: five questions to ask
- What leak rate must you detect? Start from the product risk, not the equipment catalogue.
- What cycle time does the line need? Test time often sets the pace of an entire cell.
- How will results be recorded? Look for traceability by part, batch and operator, with data export to your MES or quality system.
- Can the instrument be validated easily? Calibration, reference leaks and stable test programmes make IQ, OQ and PQ faster.
- Who supports it locally? Downtime on a medical line is expensive. Local application engineers and quick service matter.
Why Dutch manufacturers choose ATEQ
Experience: Nearly fifty years of leak testing across medical, automotive, packaging and aerospace production.
Range: Pressure decay, flow and vacuum solutions, from benchtop instruments to fully integrated test stations.
Support: Application testing on your own parts, help with validation, and service from ATEQ’s team in the Benelux.
