Mitigating the Risk of Implementing Single-Use Assemblies for Final Sterile Filling
|Sue Walker, Global Product Manager - Final Fill
ACHEMA Praxis Forum
Hall 4.2, Brillianz
Friday, 19 June, 12:30
There are significant benefits to single use technologies that have been well documented. However there are also risks associated with their use that can include product loss and questions around sterility assurance and product safety. These risks are magnified in the filling operation because of its closeness to the final product in its final form. But there are ways to mitigate these risks during final fill assembly design, manufacture, and use.
By creating a sound initial design where the supplier and the end user work together to customize the design – fit for intended use will not be based solely upon verification after installation but it will be designed into each assembly. And by systematically evaluating the assembly manufacture and quality control processes, risks can be highlighted and properly addressed. Topics such as gamma irradiation qualification, shipping validation, particulates, and integrity testing as they relate to assembly manufacture will be covered. And the final section of the presentation will discuss the key aspects for successful assembly implementation by the end user at the point of use.
Ensuring Scalable Performance of Single-Use Bioreactors from Bench to Clinical Scale
|Janice Lloyd Simler, Ph.D., Global Sr. Product Manager
Hall 3, Facette Room
Wednesday, 17 June, 16:40
Bioreactor process set points and parameters developed in bench-top bioreactors are used in the large production scale bioreactors. It is therefore crucial that the set points developed at the small scale can be easily transferred to large scale. This presentation will highlight how a detailed understanding of the performance design space of each sized bioreactor can enable the selection of process parameters at each scale that will enable scalable performance across the platform.
Merck Booth Happy Hours
Starting on the first day of ACHEMA, Merck will be hosting a daily happy hour in the booth (see location above). Refreshments and engaging conversations to be had.
These happy hours will take place between the hours of 16:00 and 18:00, Mon-Thurs: June 15th to June 18th.
Merck Media Kit
All recent press and ACHEMA related materials. Please check back frequently for more updates.
For media inquiries and in-booth interviews, please contact: Susan Alesina
, Head of Communications - Business Partners
Visit our ACHEMA stand, have your photo taken, and Tweet it using #ScienceFurtherFaster for a chance to win a prize!
Winners to be selected randomly and notified during ACHEMA via Twitter.
Full contest rules here
Merck KGaA, Darmstadt, Factory Tours
During the week of ACHEMA, Merck will be hosting a tour in Darmstadt on Wednesday June 17
and Friday June 19
. During the tour, you will see a presentation of Merck's research and production, view pharmaceutical production processes and chemical warehouses, and learn about career opportunities at Merck. Transportation to and from the main entrance of the CMF (hall plan
) will be provided. Time:
€ 25 transportation fee
ACHEMA Registration - Free Tickets!
Interested in attending ACHEMA? Request free tickets
. Just let us know how many you would like!
If you would like to read more information on ACHEMA, please see the ACHEMA Program
which includes a complete congress program and information on guest events and general programs as well as everything else you need to know about the event!