Bosch Packaging Technology, a German supplier of process and packaging technology, has unveiled an expanded portfolio of its PreVAS (pre-validated, pre-assembled and pre-sterilised single-use filling systems), which have been developed in cooperation with Sartorius Stedim Biotech (SSB) following an agreement signed in 2012.
'The existing system has been successfully introduced to the market. Now the time has come to offer our customers additional solutions for their existing line concepts and to consequently extend our portfolio,' said Klaus Ullherr, Product Manager at Bosch Packaging Technology.
Since the official launch, PreVAS has been established in the market and is now used by customers in Europe, the US and China, who manufacture in accordance with strict GMP guidelines and FDA regulations.
Ullherr said the company has worked on new products that meet specific customer requirements, which means that the PreVAS pump trolley is now supplied with a mobile filling station, which can be flexibly combined with existing filling lines. In this version, the product bag is situated outside the isolator, while the filling tubes are compactly and safely guided through the isolator wall via a newly developed multi-tubing port, before being connected to the filling station.
'Customers can now quickly and economically upgrade their existing lines to filling operations with PreVAS,' Ullherr said.
The multi-tubing port is also fully validated, having been tested and validated under realistic conditions for 12 months. Among others, this included performance tests for filling accuracy, biocompatibility tests, extractable and leachable studies as well as particle tests.
'Our customers receive all key components from a single source – bag, pump and tubing, as well as filling needles. Combined with comprehensive validation and technical support for upgrades, PreVAS answers the requirements of the pharmaceutical and biopharmaceutical industry for higher filling accuracy as well as safe and flexible solutions for simple and quick product changes,' Ullherr concluded.