Purac Biomaterials Facilities
Purac Biomaterials
Leader in resorbable polymers for the medical device and pharmaceutical industry
 

For the manufacturing of PURASORB®  resorbable polymers and monomers Purac Biomaterials operates from a dedicated GMP manufacturing site at Gorinchem, The Netherlands.

Our polymer manufacturing facilities allow us to operate from GMP grade batch sizes of 5 kg up to over 100 kg. Also, 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 manufacturing facility an environmental monitoring system is in place and the clean rooms are classified as grade D based on annex 1 of the EC Guide to good manufacturing practice.

We have a state of the art QC and R&D laboratory that includes a dedicated 2 kg scale pilot facility as well as extrusion and injection molding equipment for polymer development.

With our 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.


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About Purac Biomaterials

Purac Biomaterials develops, manufactures and markets resorbable polymers and monomers worldwide under the PURASORB® brand name.
Our products and services support your developments from early stage R&D to market introduction and large scale commercial supply.

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