MEDICA 2026: Increased product safety through validation-capable leak and flow testing of medical devices

CETA testing devices are used for quality control in a wide range of medical products. (Copyright: © CETA Testsysteme GmbH)

The CETA Test Systems GmbH, a specialist in industrial leak and flow testing, presents solutions for the quality control of medical devices, assemblies, and components at MEDICA 2026. The non-destructive testing methods using compressed air as the test medium enable 100% inspection directly in the production process. CETA testing devices are used worldwide in automated manufacturing lines for quality assurance and allow reliable detection of even the smallest leaks as well as the verification of functional product features. This helps manufacturers of medical devices to reliably meet the high requirements for product safety, process stability, traceability, and regulatory compliance, while sustainably reducing quality costs.

Risk minimization through 100% inspection of medical devices

Medical devices must meet the highest quality and safety standards. Even the smallest leaks or deviations in flow values can impair the function of a product and, in the worst case, impact patient safety. Therefore, an increasing number of manufacturers rely on automated testing procedures that check each individual product before delivery. With CETA leak and flow testing devices, a reliable and documentable 100% inspection is possible as part of a validated production process.

Support in qualification and validation of testing processes

In addition to the actual testing task, qualification and validation of production processes are gaining increasing importance. As an experienced solution partner, CETA comprehensively supports manufacturers in qualifying and documenting their processes along the entire DQ, IQ, OQ, and PQ chain. Collaboration begins early in the development phase with targeted feasibility studies and the use of optimal testing procedures. In production, CETA testing devices ensure the highest level of process safety, transparency, and traceability through reproducible measurement results and comprehensive documentation.

Testing methods using compressed air for a variety of applications

The non-destructive testing methods employed by CETA use compressed air as the test medium. Normative testing methods for non-destructive testing are used here, as described in DIN EN 1779 (criteria for selecting leak testing methods) and DIN EN 13184 (pressure change method).

The CETA testing device portfolio includes, among others, leak testing devices with differential and overpressure sensors and devices for measuring mass flow and volumetric flow.

These are suitable for quality testing in numerous applications in medical technology, 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

100% leak testing is increasingly important for both medical devices and pharmaceutical packaging. As part of Container Closure Integrity Testing (CCIT), CETA leak testing devices enable non-destructive and quantitative testing of packaging systems such as syringes, vials, ampoules, blisters, or bags. The highly precise measurement methods detect even the smallest leaks and are suitable for automated inline inspection of each individual product unit.

The testing devices feature industrial interfaces, enabling integration into higher-level, validated IT systems and fulfilling the requirements of FDA 21 CFR Part 11 regarding data integrity, audit trail, user management, and electronic data storage. Thus, CETA leak testing devices make an important contribution to product safety, process security, and regulatory compliance in accordance with CCIT requirements. The testing methods used are aligned with USP for deterministic testing methods and can be implemented according to ASTM F2338 standards.

Accredited calibration laboratory | Traceable measurement technology

A particular benefit for customers in regulated industries is CETA's accredited calibration laboratory for pressure and flow measurements in gases (certified according to DIN EN ISO/IEC 17025). The calibrations are internationally recognized and ensure metrological traceability of the test equipment used. The accredited calibration certificate is included as standard. This provides users with the foundation for auditable and traceable testing processes right from commissioning.

Higher process safety and lower quality costs

In addition to meeting regulatory requirements, automated leak and flow testing also offers significant economic advantages. Faulty products are identified during production, reducing scrap and rework, and avoiding costly complaints and product recalls. The combination of high-resolution measurement technology, use of normative testing procedures, accredited calibration, extensive application experience, and a warranty of three years (extendable up to 5 years) makes CETA testing devices a reliable long-term solution for quality assurance in medical technology.

CETA Test Systems GmbH – Experience ensures product safety

For over 35 years, CETA Test Systems GmbH has been developing testing devices for industrial leak and flow testing. The comprehensive range of services includes feasibility studies, the development of customized testing concepts, and integration into testing stations. Through standardized interfaces and easy integration into PLC and production management systems, CETA testing devices make an important contribution to quality assurance.

Several thousand CETA testing devices are in use worldwide in production lines for quality assurance.

CETA at MEDICA 2026 | Live demonstration of a leak test

Visitors to MEDICA 2026 (November 16-19, 2026, Düsseldorf) can learn about current solutions for leak and flow testing at CETA's booth and discuss specific applications in medical technology. A special highlight of CETA's trade fair presentation is the live demonstration of a catheter leak test.