PAA Austria
In order to meet the strong rising demand for high-quality cell culture products, PAA Laboratories decided to build up a new, state-of-the-art, FDA registered, cGMP-compliant manufacturing plant outside of Linz, Austria which was officially inaugurated in October 2003. This 5000 m3 pharmaceutical plant meets the most stringend US and European cGMP regulations and is validated according to the ICH guideline of the manufacture of Active Pharmaceutical Ingredients (API's). It is one of the most advanced facilities of its kind in Europe which will help PAA to become a highly qualified supplier to all customers active in biologic vaccine and drug production, industrial in-vivo organ transplantation, tissue engineering and other critical fields.
Licenses
- cGMP 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 according to FDA standard) system
- 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
- 12.000 m3 raw material and finished products warehouse