AUSTAR is committed to the service and R&D of Pharmaceutical liquid process system, and provides a variety of advanced solutions for pharmaceutical enterprises and pharmaceutical liquid process system needed by pharmaceutical industry. Such as pharmaceutical water system, Pharmaceuticals preparation system and CIP/SIP system etc.. Product application involves in domestic and overseas active pharmaceutical ingredient, Solid oral dosage form, LVP, powder-injection and biological agent etc. We own rich experience in project management, process design, engineering construction, commissioning and validation service. We can provide liquid process system conforming to current Chinese GMP, EU GMP and cGMP. Through scientific and rational design, risk analysis before engineering construction, self-manufacturing of main equipment, high quality installation, perfect validation and after-sales service.
AUSTAR Clean Room System department with 240,000.00㎡ annually output, has more than ten years production experience on pharmaceutical clean room system. AUSTAR can independently design, manufacture and install clean room partition walls, suspended ceilings, doors, windows, aluminum profiles, accessories and related auxiliary equipment, facilities which comply with U.S. FDA cGMP, EU GMP and CFDA new GMP. AUSTAR pharmaceutical automation solutions are widely used by many multi-national pharmaceutical enterprises, it helps the pharmaceutical enterprises to shorten product time-to-market, enhance enterprise’s efficiency, and continuously improve the quality and safety of products. The solutions integrate sophisticated industrial control technologies, abundant engineering experience and high quality after-sale services.
Containment isolation system is quickly developing with the new market demand. AUSTAR providing high quality powder engineering system solution for the pharmaceutical, fine chemical, food and other industries. It can provide complete enterprise-level solutions for the whole development and production by integrating the capacity and experience in the aspect of the aseptic pharmaceutical process engineering, containment isolation system of high activity and toxicity materials, radioactive nuclear fuel powder engineering and bulk material containment batching engineering, and starting from customer benefits. We integrated the sophisticated powder handling technology, abundant engineering experience, and technical support from all over the world into our solutions. We have engineers skilled at equipment design and manufacturing process, ensuring the project specification is implemented as planned in strict accordance with the project management mode, meanwhile providing the customers with comprehensive traceability validation documentations.
The Drug Life Cycle Compliance Consultant Service Department of AUSTAR was founded in 2000. It has numerous senior GxP experts of the pharmaceutical industry around the globe and cooperates with several famous consulting institutes outside China. Our mission is to help our clients to achieve operation excellence in the highly competitive business environments by improving the regulatory compliance and obtaining sustainable competitive advantages. Guided by the latest regulations and guidelines around the globe, the services of the department are centered on the pharmaceutical quality system and dedicated in providing GxP compliance services meeting FDA, EMA, CFDA, MHRA, PIC/S and WHO requirements throughout the product life cycle for the pharmaceutical industry through our strong project management and execution team, experienced overseas consultants and experts and the complete validation instruments imported from EU and the US. Up to now, we have successfully serviced hundreds of pharmaceutical enterprises. Adhering to the customer satisfaction oriented concept, AUSTAR provides compliance consultancy services covering the entire product life cycle in such aspects as QbD based research and development and clinical study quality system consultancy services, technology transfer management consultancy services, ICH Q10 based pharmaceutical quality system consultancy services, commissioning and verification technical services, intelligent system planning technical services, lean production consultancy services, etc. AUSTAR has been developed into a global company dedicated in providing consultancy services to our pharmaceutical clients adopting scientific principles and risk analysis approaches.
AUSTAR imports advanced scientific research, industrial consumables and laboratory instruments/equipments from Europe and the US, to provide high quality products to manufacturers and scientific research institutions of biological products, oral dosage, and large volume injection. At the same time AUSTAR is devoted to provide one-stop service which includes technical documentation support, onsite installation training and application guidance to customers. Beyond that, we could also provide compliance and consultant service of regulations and productions to the customers who need to be certificated or qualified by FDA cGMP, CoS or other certificates. AUSTAR is the preferred supplier of consumables and laboratory instruments/equipments for pharmaceutical corporations.
Agency and sales for imported equipment is one of AUSTAR traditional business, we introduce advanced pharmaceutical technique and process from America and Europe, as well as taking improvement process and technique of pharmaceutical enterprise as mission. In recent 20 years, AUSTAR is committed to leading development for pharmaceutical equipment as starting point, combined with customers’ requirement and advanced philosophy, as well as top , provide comprehensive solution, “one-step” solid dosage equipment, sterile filling equipment and inspection machine, as well as Wash Disinfection Sterilization machine and so on.
AUSTAR provides integrated solutions for sterile drugs, including packaging container washing, sterilization, filling, sealing, package leaking detection, visual inspection for foreign matters and appearance completeness inspection, resonable design matching, high efficient solutions, and provides "one-stop" &"turnkey" services for customers.