RAUMEDIC AG obtains ISO 15378 certification for primary packaging material

Helmbrechts – RAUMEDIC AG, a producer of plastic medical and pharmaceutical products, has been certified by TÜV SÜD according to the ISO 15378 primary packaging materials standard. Based on DIN EN ISO 9001, ISO 15378 specifies a large number of additional requirements particularly for primary packaging materials that come in contact with drugs.

The significance of ISO 15378 certification has increased steadily in recent years. The content of this international standard includes requirements from the German Drug and Active Agent Production Directive (AMWHV) and relevant GMP requirements. Certification is an important step for RAUMEDIC as a developer and producer of primary packaging materials in order to satisfy the high expectations of drug manufacturers.

"By meeting the criteria of ISO 15378 with respect to risk management, the work environment, and validation, we offer our customers even greater safety for hygienically flawless and safe primary packaging materials” says Dr. Ernst Schmiedl, Head of Quality Management. "From product and tool design and prototyping to manual, semiautomatic, and even fully automatic assembly, all processes are covered."

The production processes at RAUMEDIC are subject to an integrated quality management system (QMS) and the rules of good manufacturing practice (GMP), through which the required quality standards are met. Furthermore, RAUMEDIC ensures compliance with the FDA requirements from the Code of Federal Regulations for medical products.

RAUMEDIC AG's DIN EN ISO15378:2011 certificate

Primary packaging material from areas such as injection, inhalation, and drug delivery will be produced at Raumedic in accordance with DIN EN ISO 15378:2011 from now on.