Riegler supplements quality management with standards for primary packaging materials

Primary packaging materials according to DIN EN ISO 15378 from ISO Class 7 cleanrooms.

As part of the re-certification of ISO 13485 and 9001, Riegler GmbH & Co. KG was successfully certified for the first time according to ISO 15378, effective from October 31, 2019. With ISO 15378, the requirements of ISO 9001 are linked with the specific requirements for "Good Manufacturing Practice (GMP)" for primary packaging materials. The quality management system thus ensures the high international standards according to the norm for pharmaceutical and medical primary packaging.

"For our company, this is another important step into the future. By expanding the certification, we demonstrate the high product quality and successful quality development at Riegler," says André Neubauer, who is responsible for quality management at Riegler GmbH & Co. KG. Based on a certified, practically implemented management system, the medical technology specialist Riegler meets customer specifications, regulatory requirements for cleanroom processes, and the needs for sustainable, resource-efficient production. "The additional certification is another step in the continuous and sustainable positive development and quality orientation of our employees," says Dr. Thomas Jakob, Head of the Medical Technology Business Unit.

Company Profile

Since 1946, Riegler GmbH & Co. KG has been a powerful system supplier in plastics processing and a development partner for plastic-based product solutions. With a focus on quality and innovation, Riegler is also known internationally in the fields of diagnostics, medical technology, pharmaceuticals, and packaging – and this with highly precise, customer-specific components, assemblies, and systems. Core competencies include development, design, toolmaking, injection molding, and blow molding, as well as a wide range of assembly, finishing, and logistics services. Most of the production takes place in cleanrooms according to ISO 14644-1 Class 7. The highest uniform quality and hygiene standards are ensured through a comprehensive, certified quality management system in accordance with ISO 13485, 9001, 15378, and ISO 50001.

Over 300 employees work on approximately 55,000 square meters across three locations in the Hessian Mühlthal and Ober-Ramstadt.

Since 2005, Riegler GmbH & Co. KG has been a subsidiary of the internationally operating, family-run Wirthwein Group. With 22 companies worldwide in Europe, Asia, and the USA, the Wirthwein Group is close to its customers everywhere. More than 3,650 employees work in the business fields of automotive, rail, electrical industry, household appliances, medical technology, and interior construction within the Wirthwein Group.