Source: Deutsche Nachrichten
CETA Testsysteme GmbH, a specialist in industrial leak and flow testing, will present solutions for the quality control of medical devices, assemblies, and components at MEDICA 2026. The non destructive testing methods, which use compressed air as the test medium, enable 100% routine testing directly within the production process. CETA test devices are used worldwide in automated production lines for quality assurance and enable the reliable detection of even the smallest leaks as well as the verification of functional product characteristics. In this way, CETA supports medical device manufacturers in reliably meeting the high requirements for product safety, process stability, traceability, and regulatory compliance, while sustainably reducing quality-related costs.
Risk minimisation through 100 % routine testing of medical devices
Medical devices must meet the highest quality and safety standards. Even the slightest leaks or deviations in flow rates can impair a product’s function and, in the worst-case scenario, affect patient safety. Consequently, an increasing number of manufacturers are turning to automated testing procedures that inspect every single product before dispatch. CETA leak and flow testers enable reliable 100 % routine testing with complete documentation and traceability.
Support during qualification and validation of test processes
In addition to the testing task itself, the areas of qualification and validation of production processes are becoming increasingly important. As an experienced solution partner, CETA provides manufacturers with comprehensive support in the qualification and documentation of their processes throughout the entire DQ, IQ, OQ and PQ chain. The collaboration begins as early as the initial development phase with feasibility studies and the identification of optimal test methods. In production operations, CETA’s test equipment ensures the highest level of process reliability, transparency and traceability through reproducible measurement results and comprehensive documentation.
Testing methods using compressed air as the test medium for a wide range of applications
The non-destructive testing methods used by CETA employ compressed air as the test medium.
The methods are based on standardised non-destructive testing procedures as described in DIN EN 1779 (Criteria for the selection of leak testing methods) and DIN EN 13184 (Pressure change methods).
The CETA range of test devices includes leak testers with differential pressure and gauge pressure sensors, and devices for measuring mass flow and volumetric flow. This makes them suitable for quality testing in a wide range of medical device applications, such as:
• Endoscopes, catheters and tubing systems
• Infusion and transfusion systems
• Filters and filter assemblies
• Ventilation components
• Disposable items
• Drug delivery systems
• Plastic assemblies and medical connection systems
Quality control of pharmaceutical packaging
The 100% leak test is becoming increasingly important for both medical devices and pharmaceutical packaging. As part of Container Closure Integrity Testing (CCIT), CETA leak-test devices enable non destructive and quantitative testing of packaging systems such as syringes, vials, ampoules, blister packs and pouches. The high-precision measurement methods detect even the smallest leaks and are suitable for automated in-line testing of every single product unit.
The test devices are equipped with industrial interfaces. This enables their integration into higher level, validated IT systems and supports compliance with FDA 21 CFR Part 11 requirements regarding data integrity, audit trails, user management and electronic data storage. As such, the CETA leak testers make an important contribution to product safety, process reliability and regulatory compliance in accordance with CCIT requirements. The qualification of the employed deterministic test procedures can be aligned with the principles described in USP . Depending on the application, relevant ASTM standards (like ASTM F2338) may also be considered.
Accredited calibration laboratory | Metrological traceability
An important advantage for customers in regulated sectors is CETA’s accredited calibration laboratory for the measurement of pressure and flow in gases (certified to DIN EN ISO/IEC 17025). The calibrations are internationally recognised and ensure the metrological traceability of the test equipment used. The accredited calibration certificate is included as standard. This provides users with the basis for auditable and traceable test processes right from the start of commissioning.
Higher process reliability and lower quality costs
As well as meeting regulatory requirements, automated leak and flow tests also offer significant economic benefits. Faulty products are detected during production, reducing scrap and rework while helping to avoid costly complaints and product recalls. The combination of high-resolution measurement technology, the use of standardised test procedures, accredited calibration, many years of practical experience and a three-year warranty (extendable up to five years) makes CETA’s test equipment a long-term, reliable solution for quality assurance in the medical technology sector.
CETA Testsysteme GmbH – Experience ensures product safety
For more than 35 years, CETA Testsysteme GmbH has been developing test devices for industrial leak and flow testing. Its comprehensive range of services extends from feasibility studies and the development of customer-specific test concepts through to integration into test stations. Thanks to standardised interfaces and easy integration into PLCs and production control systems, CETA test devices make a significant contribution to quality assurance. Several thousand CETA test devices are in use worldwide for quality assurance in production lines.
CETA at MEDICA 2026 | Live demonstration of a leak test application
Visitors to MEDICA 2026 (16–19 November 2026, Düsseldorf) can find out about the latest solutions for leak and flow testing at the CETA stand, as well as discuss specific use cases from the medical technology sector. A particular highlight of CETA’s exhibition presence will be a live demonstration of a catheter leak test.
CETA at the MEDICA 2026 trade fair, 16–19 November 2026 in Düsseldorf
Hall 3, Stand C 80 – Community stand for the State of North Rhine-Westphalia
Further information
CETA Homepage
Medica 2026
CETA exhibitor profile at the Medica 2026
CETA Product Overview