As a subsidiary of AUSTAR group, PALL-AUSTAR is a technology company dedicated to research, development and production of sterile packing materials and single use technology product (SUT) for biopharmaceutical purpose. Conducting design and construction service according to FDA cGMP and GMP of EU requirements, PALL-AUSTAR is devoted to developing super clean medicinal sterile packing material and breathing bags for super clean medical packing and providing customers with bioreactor solutions (including the single use sterile packaging consumables) and sterile transfer solutions applicable to RABS and ISOLATOR system. The company introduces PALL Life Science SUT technology and quality management system to ensure verification and processing confirmation of each process from raw material selection to final product testing. PALL-AUSTAR has already built an ISO5 clean workshop of 1500 square meters with background of ISO7. Now the company has an annual production capacity of 1,000 tons of sterile packaging film bags, 10 million Tyvek/ polyethylene Cleansteam bags for pharmaceutical packaging purpose, and 10,000 pieces of all kinds of single use bio-pharmaceutical technology products (SUT), serving more than 500 clients at home and abroad.
Biopharmaceutical single use technology product testing lab is built in accordance with international standards. It is a comprehensive experimental platform for testing and verifying packaging materials of sterile products and biopharmaceutical single use technology (SUT) products. The lab is equipped with an experienced professional testing team and professional testing instruments. With its physical laboratory, chemical laboratory and biological laboratory, the testing center can analyze biopharmaceutical single use technology (SUT) products according to standards of Chinese pharmacopoeia, USP, EP and BPOG and carry out systematic verification in accordance with regulatory requirements. The testing lab for biopharmaceutical single use technology product can effectively help customers reduce process development cost and production costs and open up more new opportunities.