Cutting edge on pharmaceutical filling and finishing for nested syringes

The company is a world leader in sterile filling of ampoules, vials, cartridges and syringes. Its machines set international standards in these fields. High quality standards of documentation, qualification and validation are crucial to facilitate a quick integration of machines in production systems. Bosch Pharma has an extensive portfolio for filling and processing of nested, presterilised syringes.

Efficient processes are a key competitive factor for reducing costs. Bosch is the first company to offer all steps – from filling to inspection to final packaging – from one source. Because Bosch manufactures every processing step, all components are completely compatible. As a result, customers benefit from the significant reduction of interface risk and costs as well as better performance and higher dependability. In addition, Bosch provides project management for process line integration, which relies on extensive experience in sterilisation, filling and finishing. Bosch Pharma solutions are available as individual modules or in a complete package. Bosch is also the only supplier in the pharmaceutical sector to offer a pharmaceutical lab to perform tests and studies.

The process line consists of three steps: sterile fill finish, inspection and final packaging. The first step, manufactured by Bosch Pharma, includes debagging, outside sterilisation with e-beam, delidding, filling and stoppering with Bosch filling systems and barrier systems (like isolator or restricted-access barrier systems – RABS). Barrier systems are an essential aspect of the Bosch systems for filling pre-sterilised, nested syringes. Bosch is the only equipment company to offer fully integrated isolators, which provide aseptic environments over traditional clean rooms by separating the filling area from the operators. RABS offer an efficient alternative for sterile filling and more process flexibility in certain fields.

The second step of the process line draws from the knowledge of Bosch’s subsidiary Moeller & Devicon, which conducts de-/re-nesting, inspection, plunger rod insertion and labelling. Bosch Sigpack Systems delivers the expertise for the third step. It includes the final packaging (e.g. thermoforming, top loading, case packing and palletising). Bosch Pharma is the first company to introduce such a complete process line for presterilised syringes from one single source.

Under the umbrella of Bosch Packaging Technology, Bosch Pharma offers a large variety of machines for all processing steps. For example, an automatic bag opener (ABO) minimises the risk of recontamination. A pharma handling unit (ATO) conducts an entirely automatic delidding of the tub cover and inner Tyvek foil in order to prepare the filling operation. The FXS 5100 high-speed automatic filling and sealing machine comes with a special syringe transport and IPC system. For smaller outputs the FXS 2020 automatic filling and sealing machine performs manual and automatic loading as well as optional check weighing. They are ideal for galenic solutions. In addition, Bosch Pharma developed an outside sterilisation system with an e-beam for isolator applications in cooperation with a specialist partner.

Find out more: contact Klaus Ullherr, Product Manager. Phone: +49 7951 402 517. E-mail: Klaus.Ullherr@boschpackaging.com

FXS_2020
FXS 2020: performs manual and automatic loading as well as optional check weighing.

FXS_5100
FXS 5100: comes with a special syringe transport and IPC system.

CVT_Slitec
Bosch machines set international standards in sterile filling of ampoules, vials, cartridges and syringes.

Efficient processes are a key competitive factor for reducing costs.