close
Pharma and Biotech
Menu
close
Pharma and Biotech
close
Pharma and Biotech
Menu
close
Pharma and Biotech
Pharma and Biotech
Menu
close
Smart. Integrated. Reliable. Your home for turnkey. With the focus “Your home for turnkey”, Optima Pharma underlines its special market position. With Optima, you will find a reliable partner to provide you holistic advice and support you with your individual requirements. We can provide a complete turnkey system with filling solution, isolator, and freeze dryer from a single source. Your partner and home for turnkey.
How can you get your newly licensed pharmaceutical and biotech products to market as quickly as possible? As a manufacturer, CMO (Contract Manufacturing Organization) or CDMO (Contract Development and Manufacturing Organization), reduced time to market is a crucial factor. Meanwhile, you require increasingly flexible and complex systems. We have listened to you closely and developed an approach that considerably reduces time between your system's design and production start. As a system partner and turnkey provider, we deliver completely integrated systems, including filling lines, isolators and freeze-dryers. Interested? Contact us and we will show you how Optima can help reduce your time to market.
The CSPE approach cuts delivery times and significantly reduces start-up times of pharmaceutical systems.
CSPE encompasses a wide range of tools that act as catalysts from the design phase to the operational phase. This becomes tangible and real in one of Optima's CSPE centers. Enabling an integrated FAT (iFAT) that lives up to its name – by supplying media such as process heat or cold, compressed air and treated water. The twelve-meter high assembly halls provide space to build multi-story pharmaceutical systems. This includes assembly, commissioning and qualification tests of filling and closing systems, isolators and freeze-dryers.
The CSPE approach means you can start your production quickly and safely. CSPE stands for Comprehensive Scientific Process Engineering. It expedites the implementation of your turnkey system using digital engineering, simulation, VHP cycle development and qualification measures before delivery and an integrated Factory Acceptance Test (iFAT).
These measures eliminate unnecessary steps and speed up the start of production. Comprehensive turnkey systems in particular launch more quickly, as CSPE includes complete in-house qualification by Optima and makes regulatory audits easier.
With CSPE, we are switching from an experienced-based model to an integral, data-driven model that will lead to continuous improvement that is deterministic and no longer random.
In order to expedite your time to market, we simulate comprehensive processes in the CSPE and carry out an integrated factory acceptance test (iFAT) for your entire system. We build filling and closing systems, isolators and freeze-dryers and test them as a unit, under real-life conditions during the iFAT. Scroll down for more information on the CSPE components.
Before designing the system, we optimize the dispersion of VHP (Vaporized Hydrogen Peroxide) in the isolator. Using simulations, we create the optimal initial conditions for cycle development. No need to repeat tests on site, which saves several months of installation and qualification time at your location.
During the integrated Factory Acceptance Test (iFAT), we assemble all of your system's components in our CSPE Center in Schwäbisch Hall where we test and qualify them under the most realistic conditions possible. This includes interfaces, leak tests or SCADA integration: You can start-up safely and quickly with your tested turnkey system.
Even faster and more comprehensive: We will continue to expand the successful concept for you with the new CSPE 2.0. Work that typically took place at your site in the past will shift to one of Optima's CSPE centers. This includes installation and operational qualification, as well as parts of the performance qualification.
In order to expedite your time to market, we simulate comprehensive processes in the CSPE and carry out an integrated factory acceptance test (iFAT) for your entire system. We build filling and closing systems, isolators and freeze-dryers and test them as a unit, under real-life conditions during the iFAT. Scroll down for more information on the CSPE components.
Before designing the system, we optimize the dispersion of VHP (Vaporized Hydrogen Peroxide) in the isolator. Using simulations, we create the optimal initial conditions for cycle development. No need to repeat tests on site, which saves several months of installation and qualification time at your location.
During the integrated Factory Acceptance Test (iFAT), we assemble all of your system's components in our CSPE Center in Schwäbisch Hall where we test and qualify them under the most realistic conditions possible. This includes interfaces, leak tests or SCADA integration: You can start-up safely and quickly with your tested turnkey system.
Even faster and more comprehensive: We will continue to expand the successful concept for you with the new CSPE 2.0. Work that typically took place at your site in the past will shift to one of Optima's CSPE centers. This includes installation and operational qualification, as well as parts of the performance qualification.
CSPE encompasses a wide range of tools that act as catalysts from the design phase to the operational phase. This becomes tangible and real in one of Optima's CSPE centers. Enabling an integrated FAT (iFAT) that lives up to its name – by supplying media such as process heat or cold, compressed air and treated water. The twelve-meter high assembly halls provide space to build multi-story pharmaceutical systems. This includes assembly, commissioning and qualification tests of filling and closing systems, isolators and freeze-dryers.
Real-life examples show the advantages offered by Optima's sophisticated solutions. Immerse yourself in our success stories and be inspired.
What are you especially interested in?
