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What moves the pharmaceutical and biotech industries?

Processing highly potent APIs (Active Pharmaceutical Ingredients) safely and holistically

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The development of Highly Potent Active Pharmaceutical Ingredients (HPAPI) is steadily increasing. And no wonder: these individually tailored active ingredients are achieving great success in oncology, for example.For pharmaceutical companies, processing and filling highly potent drugs is full of challenges: Small volumes and quantities demand a great containment effort. We provide you with all-round support for these tasks, thanks to our holistic process and complete turnkey systems.

Why OPTIMA is the right partner for you Turnkey systems for highly potent APIs

Processing highly potent APIs requires robust safety measures for both people and products. Room and machine must form a functioning overall system to ensure safety. We provide comprehensive advice on room, pressure and wastewater concepts, as well as on decontamination and containment. It is also important to take a detailed look at the interfaces between the filling line, freeze-drying and isolator. Plan your fully developed complete system together with us.

High Potent Machine
Why OPTIMA is the right partner for you Turnkey systems for highly potent APIs

Processing highly potent APIs requires robust safety measures for both people and products. Room and machine must form a functioning overall system to ensure safety. We provide comprehensive advice on room, pressure and wastewater concepts, as well as on decontamination and containment. It is also important to take a detailed look at the interfaces between the filling line, freeze-drying and isolator. Plan your fully developed complete system together with us.

High Potent Machine
The benefits of OPTIMA to you
  • Turnkey
  • Machine design
  • Consulting
  • Cleaning
  • Isolator and filter
  • Freeze-drying
Next
Three people working on one machine
Turnkey

As a turnkey partner, we supply you with complete turnkey systems. The advantage: A complete system for processing highly potent APIs saves time and ensures maximum safety for both people and products from one source.

Detail view of a high-potent machine
Machine design

To ensure that your machine is easy to operate and ready to process sterile products, we work on an optimized design tailored to your needs. The carefully planned design also prevents any contamination from being transferred.

Group of people in meeting room
Consulting

Integrated turnkey lines for the processing of highly potent APIs: Benefit from our consulting expertise in design and implementation of your system. We will continue to support you throughout the entire life cycle of your machines.

Detail view of a high-potent machine
Cleaning

Uncompromisingly high standards ensure the purity and quality of your pharmaceutical products. With Optima, you choose from various cleaning concepts for safe and effective cleaning of your entire system.

Detail view of a high-potent machine
Isolator and filter

Different isolator and filter concepts ensure maximum product and personal protection. That is why we support you with a wide range of containment solutions to manufacture your pharmaceuticals safely and reliably.

loading vials into a lyophilizator
Freeze-drying

We adapt the design of modular freeze dryers exactly to your production processes. This ensures that the process steps interlock without any production downtime. For example, gentle handling of your vials is also ensured during loading and unloading.

The benefits of OPTIMA to you

Turnkey
Three people working on one machine

As a turnkey partner, we supply you with complete turnkey systems. The advantage: A complete system for processing highly potent APIs saves time and ensures maximum safety for both people and products from one source.

Machine design
Detail view of a high-potent machine

To ensure that your machine is easy to operate and ready to process sterile products, we work on an optimized design tailored to your needs. The carefully planned design also prevents any contamination from being transferred.

Consulting
Group of people in meeting room

Integrated turnkey lines for the processing of highly potent APIs: Benefit from our consulting expertise in design and implementation of your system. We will continue to support you throughout the entire life cycle of your machines.

Cleaning
Detail view of a high-potent machine

Uncompromisingly high standards ensure the purity and quality of your pharmaceutical products. With Optima, you choose from various cleaning concepts for safe and effective cleaning of your entire system.

Isolator and filter
Detail view of a high-potent machine

Different isolator and filter concepts ensure maximum product and personal protection. That is why we support you with a wide range of containment solutions to manufacture your pharmaceuticals safely and reliably.

Freeze-drying
loading vials into a lyophilizator

We adapt the design of modular freeze dryers exactly to your production processes. This ensures that the process steps interlock without any production downtime. For example, gentle handling of your vials is also ensured during loading and unloading.

Team HighPotent
Do you have questions or would you like to discuss your specific requirements with Optima's experts?
Team HighPotent
OPTIMA pharma
+49 791 9495 - 0 customer.info@optima-packaging.comWrite e-mail
Team HighPotent
Team HighPotent
OPTIMA pharma

Servier invests in multiuse system for highly potent APIs

For the production of biologics and small molecules for oncology, the French pharmaceutical company Servier relies on a flexible multiuse turnkey system from Optima, including a freeze dryer and isolator for highly potent APIs.

Christophe Assourd, Head of Pharmaceutical Industrial Development at Servier, France

Besides the criteria of the integrated design and project management of the filling system, aseptic isolator and freeze dryer, we were convinced by the state-of-the-art technology of the flexible line and its '4.0 compliance'.

Christophe Assourd, Head of Pharmaceutical Industrial Development at Servier, France
OPTIMA technologies for highly potent APIs
OPTIMA technologies for highly potent APIs
High Potent Machine
Pressure and space zone concepts
Isolator design and filter concepts
Cleaning and wash down
Machine design
External washing machines
Freeze-drying with loading and unloading
High Potent Machine
Pressure and space zone concepts

Together, we discuss your sophisticated room concept and define the different pressure zones. A pressure zone concept must reconcile many requirements within the turnkey system, including the coordinated pressure cascade, operator and product protection, and airflow.

Isolator design and filter concepts

Choose from various filter concepts for the containment in the isolator: HP (High-Performance-Filter), BiBo (Bag-in-Bag-out-Filter) and BiBo with flap. Which best fits your needs? We will discuss the specific advantages with you in detail.

Cleaning and wash down

Choose from different options to find the right cleaning concept for your easily accessible system. A simulation of your cleaning processes helps to arrive at the right design for you. Wash down can be either manual or semi-automatic. Alternatively, we can position automatic cleaning nozzles - completely individually according to your requirements.

Machine design

Highly potent APIs require an optimized machine design. This simplifies your special transport systems and prevents contamination from being transferred. Another bonus: Comprehensive simulations for cleanability and airflow.

External washing machines

The filling of highly potent APIs requires external cleaning of the containers. Whether vials or syringes: Optima exterior washing machines clean and dry effectively and thoroughly. This means that product adhesion on the outside doesn’t stand a chance.

Freeze-drying with loading and unloading

The freeze-drying design also adapts to your highly potent APIs. First, safe and gentle handling of your containers during loading and unloading avoids any contamination. Second, filters in the suction line of the vacuum system safely discharge the highly potent exhaust air. Third, the system neutralizes potentially highly potent substances and, fourth, it uses vacuum pumps that can be flushed and decontaminated.

Matthias Poslovski
Matthias Poslovski, Vice President Technical Sales, OPTIMA pharma GmbH

When systems for highly potent substances are designed as a complete system, human and product safety can be maximized.

Matthias Poslovski, Vice President Technical Sales, OPTIMA pharma GmbH
Turnkey SCADA solutionTurnkey SCADA solution
With highly potent APIs, it's the big picture that counts Turnkey: Comprehensively successful

When processing complex highly potent APIs, interfaces play an important role in the system. That's where the turnkey principle comes in. A comprehensive system concept in which all process steps are seamlessly interlinked. Especially in systems for highly potent APIs, where many functions are directly related.

Our CSPE (Comprehensive Scientific Process Engineering) is a breakthrough approach that reduces the time to system readiness. Measures include digital engineering, simulations, virtual reality and integrated FAT (Factory Acceptance Test).

Discover CSPE
Success stories from the pharmaceutical and biotech industries – by and with OPTIMA

Real-life examples best show the advantages offered by Optima's sophisticated solutions. Explore our success stories.

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Team HighPotent
Do you have questions about our systems and turnkey solutions or would you like to discuss your special requirements with us?
Team HighPotent
OPTIMA pharma
Team HighPotent
Team HighPotent
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 HighPotent
OPTIMA pharma
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