Bosch Packaging Technology is pleased to announce its participation at the 2019 ISPE Aseptic Conference, to be held in North Bethesda, MA, on March 18-19, 2019, with podium presentations by US-based subject matter experts in both the aseptic and barrier education tracks of the program.
Cleaning Validation of Single Use Systems for Use in Drug Product Filling Applications – presented by Dr. Laura Moody, Product Manager, Single-Use Systems
This presentation will take attendees through a case study that describes the validation of the cleaning process for the new PreVAS single-use, basket-tip filling needle. Pharmaceutical manufacturers are motivated to select single-use final fill assemblies for their processes based upon a number of factors, primarily the substantial mitigation of batch-to-batch carryover, marked reduction in post-batch exposure to toxic substances, and reductions in risks/costs connected to their products and facilities. These benefits are directly linked to the elimination of cleaning between batches; therefore the terms “cleaning” and “single-use” seem contradictory in this context. However, cleaning and associated validations may be necessary for single-use components that may become soiled during manufacturing (i.e. cutting fluids, lubricants, particulate matter). These cleaning processes must be appropriately designed, qualified, and potential sources of variability controlled commensurate with the risk they represent.
Insights into State-of-the-Art Sterile Fill Finish Operations for Aseptic and High-Potent Drugs – presented by Juergen Metzger, Specialist, Barrier Systems and Process
This talk will provide insights into how a CMO grew from a small legacy facility into a world-class medium-sized facility by upgrading to state-of-the-art aseptic filling technology. An overview of the latest equipment for aseptic and high-potent drug manufacturing will be presented. Topics will include the main drivers for such projects, key considerations, line design, qualification measures, aseptic processing, and lessons learned from long-term experience. Attendees will benefit from insights into design concepts, sophisticated isolator equipment, selection process, and advanced aseptic technology.
Interested but unable to attend? Please contact us to arrange a follow-up meeting. Our subject matter experts are available to engage on your application.
Image: Bosch single-use filling system featuring the PreVAS disposable rolling diaphragm pump (RDP) — click here for full image