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Pharma and Biotech
Your home for turnkey

Pharma turnkey solutions and CSPE

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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.

Jürgen Rothbauer, Managing Director of Optima Pharma
Jürgen Rothbauer, Managing Dircetor, OPTIMA pharma GmbH

The CSPE approach cuts delivery times and significantly reduces start-up times of pharmaceutical systems.

Jürgen Rothbauer, Managing Dircetor, OPTIMA pharma GmbH
The catalysts for your turnkey project

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.

CSPE graphic
Why OPTIMA is the right partner for you
CSPE approach explained quickly

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.

Gerhard Breu
Gerhard Breu, Chairman, Optima Pharma

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.

Gerhard Breu, Chairman, Optima Pharma
Time to market reduced with CSPE
Maximum safety during production start
Minimal risks due to complete system iFAT
These components will reduce your time to market
  • Systematically save time
  • Digital engineering and simulation
  • VHP cycle development
  • Integrated FAT (iFAT)
  • CSPE 2.0 for turnkey systems
Next
Four people in front of a machine with laptop
Systematically save time

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.

man in front of a computer
Digital engineering and simulation

From design to delivery and training: We systematically unlock the full potential of digital engineering, simulations and virtual reality. Detect possible weaknesses early, with flow simulations (CDF) or strength calculations (FEM).

woman holding test tubes in her hand
VHP cycle development

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.

Two employees assemble a CG membrane on a machine
Integrated FAT (iFAT)

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.

employee writing a document at a machine
CSPE 2.0 for turnkey systems

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.

These components will reduce your time to market

Systematically save time
Four people in front of a machine with laptop

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.

Digital engineering and simulation
man in front of a computer

From design to delivery and training: We systematically unlock the full potential of digital engineering, simulations and virtual reality. Detect possible weaknesses early, with flow simulations (CDF) or strength calculations (FEM).

VHP cycle development
woman holding test tubes in her hand

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.

Integrated FAT (iFAT)
Two employees assemble a CG membrane on a machine

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.

CSPE 2.0 for turnkey systems
employee writing a document at a machine

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.

Team Turnkey
Do you have questions or would you like to discuss your specific requirements with Optima's experts?
Team Turnkey
OPTIMA pharma
+49 791 9495 - 0 customer.info@optima-packaging.comWrite e-mail
Team Turnkey
Team Turnkey
OPTIMA pharma
assembly hallassembly hall
CSPE Center Schwäbisch Hall The catalysts for your turnkey project

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.

Success stories from Optima customers in the pharmaceutical and biotech industries

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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Team Turnkey
Do you have questions about our systems and turnkey solutions or would you like to discuss your special requirements with us?
Team Turnkey
OPTIMA pharma
Team Turnkey
Team Turnkey
OPTIMA pharma
+49 791 9495 - 0 Write e-mail
Three Optima employees
Do you have questions or would you like to discuss your specific requirements with Optima's experts?
Team Turnkey
OPTIMA pharma
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