One system supplier for integrated lines with freeze dryer
In addition to its capability in offering complete processing lines for ampoules and vials, ROTA Verpackungstechnik entered in an extended partnership with Austar to complete its port-folio with freeze drying capability, including automatic loading and unloading (ALU) systems and barrier systems as well.
Core equipment for the production of lyophilized products
Austar freeze-dryer, designed in Germany, is widely used in pharmaceutical fields including, Antibodies, Therapeutic Proteins and Peptides, Vaccines, Chemical preparations and High Potent compounds, Plasma Blood preparations, and APIs, involving different scale applications such as laboratory, pilot-scale production and commercial production etc. The production capacity ranges from 0.5m2 to 40m2. We can provide customized solutions for toxic products, organic solvent products and liquid nitrogen refrigeration according to clients’ special needs.
The Freeze Dryer ALU system can be equipped with oRABS, cRABS or isolator according to the different product requirements. Together with the filling line, they form a highly integrated sterile filling and sealing system for lyophilized powder, leading into a versatile range of applications in terms of product, container size and production capacity.
Process development support services: Freeze drying Laboratory
Equipped with cutting-edge technologies, the Austar Freeze Drying Laboratory is capable of providing comprehensive services for determination of Process critical parameters with development of freeze-drying cycle, cycle optimization and scale-up, analysis of the quality of freeze-dried product, troubleshooting and training.
The AUSTAR Freeze Drying Laboratory has the technical consulting team with extensive industry experience in freeze-drying cycle development, cycle optimization, scale-up and technology transfer, and is able to provide services to meet the requirements of development of freeze-drying cycle and freeze-dried product. By using analytical equipment such as Differential Scanning Calorimetry (DSC), Freeze Drying Microscope (FDM) and Karl-Fischer coulometer, physicochemical characteristics of the product prior to and after freeze drying could be determined, which could allow us to gain deeper understanding about the product and the process, and thereby optimizing the freeze-drying cycle, increasing the production efficiency and improving the product quality.