Facilities

For the production of PURASORB resorbable polymers and monomers PURAC biomaterials operates from a dedicated GMP manufacturing site at Gorinchem, The Netherlands. This facility was opened in 2000. In 2002 the polymer production capacity was doubled.

Our polymer production facilities allow us to operate from GMP grade batch sizes of 5 kg up to over 100 kg. Also, the flexibility of our facility allows for a broad range of polymer compositions and polymer specifications to be produced.

The facility is designed according to ISPE guidelines and consists of ISO class 6,7 and 8 clean rooms in compliance with NEN-EN-ISO 14644-1 and 14644-2 standards. For the production facility an environmental monitoring system is in place and the clean rooms are classified as grade B, C and D based on annex 1 of the EC Guide to good manufacturing practice.

In 2005 the new R&D and QA/QC building was opened. With this investment we have realized a state of the art QC laboratory as well as an R&D laboratory. The R&D laboratory includes a dedicated 2 kg scale pilot polymer production facility as well as extrusion and injection molding equipment for polymer development.

With our new QC laboratory we have the ability to work in conjunction with our customers to satisfy their need for extended analytical services and analytical method development and validation.