Quality Control for Medical Products

We take our responsibility in the development and manufacturing of products used in medical and pharmaceutical applications very seriously. Therefore, quality assurance is one of the key factors along our entire value chain.

Our trained employees, qualified systems and validated processes form the basis for this.

In our cleanrooms, we carry out a wide range of inline quality tests that are specially tailored to the needs of our customers and applications. In addition, a significant part of quality assurance takes place in our state-of-the-art measuring rooms.

Quality Assurance Throughout Each Phase of the Process

In the highly regulated environment of pharmaceutical and medical technology products, continuous quality control along the entire process chain is essential.

Quality planning is involved right from the start: from the initial inquiry, through the first design, to initial sampling and subsequent handover to series production. The handover is made to the quality inspection department, which is responsible for continuous compliance, monitoring, and assurance of the agreed quality requirements from this point onwards.

To ensure the quality of our medical products, samples are taken and measured during production. The scope and type are either defined with the customer for each product or in accordance with the standard. This enables us to identify and rectify any potential faults in the machine or tool that could affect the quality of our products at an early stage.

Quality inspection by optical measurement with the tactile measuring machine

Measurement Technology for Quality Assurance for Medical Products

Our measuring rooms are equipped in accordance with the standard. They are air-conditioned and the lighting is also regulated. Consistent conditions form the basis for correct and defined measurements.

We have a wide variety of measuring methods and systems at our sites.

The comprehensive range of optical and tactile measuring methods includes devices for quality and dimensional control of our products, such as torque testing machines, 3D coordinate measuring machines, stripe light sensing, the vacuum chamber or the liquid particle counter.

Customized Testing Concepts for Customers and Products

For our customers, our in-house specialists create and implement customized measurement and testing concepts tailored to the individual requirements of the product and application.

Our locations serve as centers of competence, where we synergistically utilize equipment and expertise to optimize capacities and resource utilization.

The requirements for the production environment vary depending on the product. An example of this is the production of RTF vials in an ISO-5 clean room cell at the Brensbach site. These ready-to-fill vials were developed for the aseptic filling of biopharmaceutical drugs and undergo special testing using liquid particle measurement.

Quality inspection with the tactile measuring machines

With the variety of measurements we can perform, we provide our customers with comprehensive analyses and precise results.

Röchling Medical Competences

Our Expertise, Your Benefit

Our customers benefit from our extensive expertise in plastics and metal processing, but also from our many years of experience in medical technology and pharma. As your solution partner, we are familiar with both the regulatory and practical requirements of creating components and products for the healthcare sector tailored to your needs. We meet the highest quality and hygiene standards and operate in strict compliance with relevant regulations, such as the Medical Device Regulation (MDR).