The Pfreimd facility is situated 60 kilometers to the north of Regensburg. It benefits from more than 50 years of experience in the production of medical plastic systems. The facility with its highly qualified staff and in-house mold engineering department is the starting point for all international production launches.
The Pfreimd facility covers the entire production chain from injection molding to assembly and control right through to clean room packaging of medical products. The product portfolio includes a variety of customized inhaler, pen systems, infusion sets, components for needless syringes, cuvettes and lancets.
The site has an overall production area of 27,800 sqm (302,325 sqft), 15,000 sqm (163,125 sqft) of which are designated for clean room production and 3,000 sqm (32,500 sqft) are controlled areas. A total of 116 injection molding machines with clamping forces of between 15 and 250 t and 35 fully-automatic assembly lines run 24/7: a highly automated production of millions of customer-specific plastic systems – fast, economic and with reliably high quality.
The facility is certified to ISO 50001, ISO 9001, ISO 13485 and ISO 14001. Pfreimd also has a manufacturing license according to the German Drugs Law, a official GMP certificate by local authorities, an AFM Japan certificate (accreditation certificate of foreign medical device manufacturer) according 13-3 Pharmaceutical affairs law, an EU-GMP certificat as well as the Japan-GMP certificate according MHLW ordinance No. 169, 2004. Pfreimd passed an inspection by the brazil food and drug administration ANVISA.