Optima Pharma offers customized filling and process solutions for the pharmaceutical and biotech industries. The company is the turnkey partner for complete lines, special solutions, and sophisticated standard machines for primary packaging, modular freeze-drying systems and isolator technologies.
How can your newly licensed pharmaceutical and biotech products get to market as quickly as possible? As a manufacturer, CMO (Contract Manufacturing Organization) or CDMO (Contract Development and Manufacturing Organization), Optima knows that reducing time to market is crucial. Meanwhile, you also require increasingly flexible and complex systems.
Comprehensive Scientific Process Engineering (CSPE) reduces the time-to-market for turnkey projects. How? CSPE expedites the implementation of the 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 accelerate production start. 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 leads to continuous improvement that is deterministic and no longer random”, says Gerhard Breu, Chairman of the Optima Pharma Division.
At the two CSPE centers in Schwäbisch Hall, filling and closing systems with isolators can be set up and tested with freeze dryers as a fully functional unit under realistic conditions. This considerably reduces the time between installation and the start of production at the customer’s site, as well as from product development to market launch.
Optima
Hall 3.0, Stand A73
