Bosch expands PreVAS portfolio

Einwegfüllsystem PreVAS: Der Name PreVAS steht für vorvalidierte (pre-validated), vormontierte (pre-assembled) und vorsterilisierte (pre-sterilized) Einwegfüllsysteme, die Bosch Packaging Technology in Kooperation mit Sartorius Stedim Biotech (SSB) entwickelt hat. / Single-use filling system PreVAS: The name PreVAS stands for pre-validated, pre-assembled and presterilized single-use filling systems, developed by Bosch Packaging Technology in cooperation with Sartorius Stedim Biotech (SSB).

PreVAS: erfolgreich im Markt erprobt: Seit der offiziellen Einführung 2012 hat sich PreVAS im Markt etabliert und ist bei Kunden in Europa, den USA und China im Einsatz, deren Produktion nach strikten MP-Richtlinien und FDARegularien ausgelegt ist. / PreVAS: well-tried in the market: Since the official launch in 2012, PreVAS has been successfully established in the market and is used by customers from Europe, the U.S. and China, who produce in accordance with strict GMP guidelines and FDA regulations.

- Successfully used by customers in Europe, the U.S. and China
- New multi-tubing port  for efficient upgrades
- All key components as weil as pre-tests from a single source

At Interpack 2014, Bosch Packaging Technology, a leading supplier of process  and packaging  technology, presented the expanded  portfolio of the single-use filling system PreVAS. "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," Klaus Ullherr, product managerat Bosch Packaging Technology said. The name PreVAS stands for pre-validated, pre-assembled and pre-sterilized single­ use filling systems, which  Bosch Packaging Technology has developed in cooperation with  Sartorius Stedim Biotech (SSB).

Fast and economic upgrades

Since the official launch in 2012, PreVAS has been successfully  established in the market  and is used by customers in Europe, the U.S. and China, who producein accordance  with  strict GMP guidelines and FDA regulations. "As with  every successful  system, the development of PreVAS is also never fully completed. We constantly work on developing new approaches  for specific customer  requirements," Ullherr  explained. With the PreVAS pump trolley, customers  now receive a mobile  filling station, which  can be flexibly combined with  existing  filling lines. ln this version, the product bag is situated  outside  of the isolator, while  the filling tubes  are compactly and safely guided  through  the isolatorwallvia the 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.

Comprehensive pre-validation

Just  like the entire  single-use  filling system, the multi-tubing port  is also fully validated. Prior to its market  launch, PreVAS was tested  and validated under  realistic conditions for one year. Amongst others  this included performance tests  for filling accuracy, biocompatibility tests, extractable and leachable  studies  as weil as particle tests. "Our customers receive all key components from a single source- bag, pump and tubing, as weil 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 weil  as safe and flexible  solutions for simple  and quick  product changes," Ullherr  concluded.