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

Quality is always our highest priority. The quality of our products and processes is assured by strictly following all procedures in our ICHQ7 guideline based quality system. All our processes and analytical methods are designed for and dedicated to the production of PURASORB® products and are validated accordingly.

For each batch a certificate of analysis is provided, showing the analytical data determined in our quality control laboratory. Additional analytical data can be made available upon request.

We are ISO-9001: 2008 and ISO-14001: 2004 certified and all our polymers and monomers are covered with a Device Master File (MAF 1346) and a Drug Master File (DMF 21817) filed at the FDA. Our customers audit our facilities on a regular basis.

 


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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.

Products and services

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Purac Biomaterials: Bringing your ideas to life