Kistler to present real-time release testing at Fakuma

Kistler will present an approach to real-time release testing for medical technology components at Fakuma 2026. The company's MedRelease Suite is intended to support a transition from sample-based release toward complete, auditable quality evidence for each manufactured component. It combines precision mold cavity pressure sensors, the ComoNeo process monitoring system, model-based quality prediction and the AkvisIO data management platform. According to Kistler, these elements provide the basis for consistent quality documentation at component level.

The approach addresses a limitation of statistical process control in regulated medical technology production. For original equipment manufacturers (OEMs) and contract manufacturing organizations (CMOs), individual component discrepancies may remain undetected when release decisions rely on sampling. At the same time, requirements relating to traceability, data integrity and complete release documentation are increasing. The MedRelease Suite is designed to help manufacturers reduce these gaps and establish a quality data record for every component produced.

Quality measurement inside the mold cavity

Conventional integrated process monitoring systems mainly assess injection molding on the basis of machine parameters, including injection pressure and screw position. These parameters describe machine behavior, but do not directly show conditions inside each mold cavity.

Kistler instead measures pressure in the cavity, where the component is formed. The cavity pressure profile represents the combined influence of key process parameters and can therefore be used as a basis for assessing component quality. Continuous acquisition and storage of measurement data, followed by analysis using a quality model, enables each manufactured component to be associated with an individual quality assessment.

The company's 6183D cavity pressure sensor has a diameter of one millimeter and is designed to provide precise measurements under demanding process conditions.

From process data to evidence for batch release

The new generation of the ComoNeo process monitoring and control system is equipped with a 21-inch display. It processes cavity pressure data in real time and assesses each production cycle against defined quality criteria. The ComoNeoPREDICT software uses these data to predict relevant quality characteristics for each injection-molded component on the basis of models.

In regulated manufacturing, quality models must be shown to operate reliably within their defined scope. The OPTIMIZE software supports the systematic development, assessment and validation of these models. AkvisIO, a centralized fleet management system, consolidates process and quality data in one location. User-based access control and an audit trail provide a consistent and traceable data basis for batch release, audits and deviation analysis.

The MedRelease Suite thus combines process monitoring, quality prediction, validation and documentation. Depending on the application and applicable regulatory requirements, manufacturers may gradually reduce conventional testing and statistical sampling after successful validation.

Temperature-based process control

Kistler's control algorithms can now use mold temperature signals in addition to pressure signals. Based on these data, ComoNeoMULTIFLOW can support more uniform filling of hot-runner molds and determine the optimal point for switching from the injection phase to the holding pressure phase. This expands the available choice of sensors and control strategies. The temperature-based switchover function is also available with the 5159A machine-integrated charge amplifier.

Quality assurance in downstream assembly

Kistler will also show solutions for downstream assembly and inspection in plastics processing. The NCFQ 2166A high-speed joining system, combined with piezoelectric force measurement technology and maXYmos NC, enables the control, monitoring and documentation of demanding assembly processes. For optical final inspection, the KVC 821 inspection and sorting system checks defined dimensional and surface characteristics at rates of up to 750 parts per minute.

Real-time release testing does not end at the injection mold. With the NCFQ 2166A high-speed joining system, Kistler also ensures precise quality control during the assembly of sensitive medical devices, such as autoinjectors and insulin pens

Together, these systems are intended to support quality assurance from injection molding through assembly to final inspection. Process data range from measurements taken directly in the mold cavity to documented joining force during assembly.

"Real-time release testing cannot be implemented with a single product. It requires precise process data, complete documentation, and reliable integration into existing production and quality processes," said Dr. Oliver Schnerr, Head of the Plastics Business Unit at Kistler. "We understand our customers' regulatory requirements and support OEMs and CMOs every step of the way during implementation. At Fakuma, we demonstrate how our combination of measurement technology, software, and application expertise provides the foundation for traceable, robust release decisions."

Kistler will present the systems in hall A3, booth A3-3210.