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Pharma and Biotech
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Pharma and Biotech
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Pharma and Biotech
Pharma and Biotech
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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.
With our turnkey systems, we are your strategic partner for the complete system with filling system, isolator and freeze dryer.
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 use intelligent processes and procedures and can therefore offer our customers high-performance and innovative turnkey solutions.
We are your strategic turnkey partner for pharmaceutical systems, offering technology and expertise from development throughout the entire product life cycle. Optima’s filling lines, isolators, and freeze-dryers are perfectly integrated as a turnkey solution from a single source. The essential part is filling and closing your products, as well as containment and freeze-drying systems.
We support you with a unique mix of industry and application knowledge, technology expertise, as well as process and service quality. We offer integrated complete systems, customized solutions, and sophisticated standard machines for primary packaging to meet your needs.
We will send you the turnkey/CSPE brochure. You will receive an e-mail with a download link.
From conception to delivery and training: We systematically unlock the full potential of digital engineering, simulations, and virtual reality. These tools can be used to detect and eliminate possible weak points at an early stage with flow simulations (CDF) or strength calculations (FEM), for example.
Already in the planning phase, VPHP (Vapor Phase Hydrogen Peroxide) values are calculated and optimized in the isolator, creating ideal conditions for cycle development. Simulations enable the early detection and optimization of worst-case positions. They help analyze airflows around filling and capping machines in isolators and RABS and predict H₂O₂ distribution during bio-decontamination. In this way, geometries and processes can be optimized, development times shortened, and cost-intensive testing reduced. Through data-driven decisions, simulations improve efficiency and safety, save time, and minimize risk.
To support our customers in complying with the EU GMP Annex 1 guideline, we carry out detailed air flow visualizations. In addition to flow simulations, this also includes smoke studies, which are performed in advance on our machines with an isolator as an integrated unit. These analyses enable precise optimization of air flow, improve process reliability, and meet regulatory requirements.
With pre-cycle development, we optimize the decontamination processes of an entire production line in advance. The first step is an in-house VPHP simulation to define starting parameters for homogeneous H₂O₂ saturation within the plant. This is followed by studies of the pre-cycle development of the turnkey lines at our headquarters in Schwäbisch Hall, Germany. This involves analyzing and optimizing the H₂O₂ and temperature distribution, as well as determining injection rates to ensure effective decontamination.
The resulting parameters serve as the basis for subsequent cycle development and validation at the customer's site. During on-site cycle development, biological indicators (BIs) are also used. These can be supplemented by enzyme indicators (EIs) as an analytical tool to determine further information about the cycle. The decontamination parameters are then validated to test for reproducibility.
Thanks to the pre-cycle development, the decisive parameters are already defined in advance, which reduces downtime and significantly accelerates the start of production. Our customers benefit from a more efficient time to market and faster regulatory approval.
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.
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