Quality is highly valued at Pöppelmann

Pöppelmann FAMAC relies on a certified quality management system according to DIN EN ISO 13485:2010 as well as a hygiene management system based on the HACCP concept.

Pöppelmann FAMAC develops and manufactures technical functional parts and packaging made of plastics for the pharmaceutical industry, medical technology, as well as the food and cosmetics sectors. Quality and service are prioritized from development to product packaging.

In the medical technology and pharmaceutical industries, it must be ensured that functional parts and packaging are produced in compliance with agreed quality targets. Pöppelmann FAMAC manufactures plastic injection-molded parts in cleanroom conditions and relies on a certified quality management system according to DIN EN ISO 13485:2010 as well as a hygiene management system based on the HACCP concept.

From development through toolmaking to production, continuous quality assurance and documentation play an important role at Pöppelmann FAMAC. Precise measurements and inspections are carried out down to the hundredth of a millimeter: because, in addition to the dimensions of a part, the appearance and colors of the plastic components must also be correct. This way, Pöppelmann FAMAC customers can rely on consistent product quality, especially during series production. "I am in constant communication with our customers. Transparency and mutual trust are very important to us," says Jörg Stuckenberg from quality assurance at Pöppelmann FAMAC.

Pöppelmann stands for quality and safety

A systematic approach is standard at Pöppelmann FAMAC. During qualification, the manufacturing process is checked in four steps from component development to tool release. The requirements for the component are specified in a design qualification (DQ) in a specifications document and implemented with an appropriate tooling concept. Once the tool is completed, it is inspected during installation qualification (IQ) to ensure it meets the specifications, and the inspection plans are coordinated with the customer.

In the phase of operational qualification (OQ), it becomes clear how specific process parameters affect the component. This involves the performance and machine capability of the tool. During performance qualification (PQ), the process capability of the component is examined. If everything is in order, the series production is approved. Continuous quality assurance and precise documentation not only build trust but also provide an optimal foundation for long-term collaboration between Pöppelmann FAMAC and partners in the pharmaceutical and medical technology industries.