PAA Austria
PAA's European manufacturing plant is located just outside of Linz, Austria.
This pharmaceutical plant meets the most stringend US and European GMP regulations and is validated according to the ICH guideline of the manufacture of Active Pharmaceutical Ingredients (API's).
With the inauguration of its dry powder media production facility in 2008, PAA has enlarged its FDA registered, GMP-compliant manufacturing plant to 10.000 m2 in order to meet the increasing demand for high-quality cell culture products. It is one of the most advanced facilities of its kind world-wide.
Licenses
- GMP Certificate
- License pursuant to §63 of the Medicines Act which entitles the company to produce pharmaceutical products
- Annual Registration of Device Establishment (FDA)
- Certificate of Suitablilty for Foetal Bovine Serum and other Bovine Sera
The most important features are:
- Three separate fill lines with a total fill capacity of 15.000 litres per day
- Validated processes to produce up to 2.600 litre "true pool lots"
- Water-for-Injection (WFI system) as per USP (EP grade in 2009)
- Clean-In-Place (CIP) and Steam-In-Place (SIP) Systems
- Product purity is protected by producing in clean room class 100, 10.000 and 100.000
- 20.000 m3 raw material and finished products warehouse
- Two air classification mills and four screw cone blenders produce powder media in batch sizes from 0.7 to 8000 kg