Manufacturing medicines, for people and animals health is a huge responsibility. Safeguarding the product, personnel and the environment are key objectives of the manufacturing process. Optima Pharma filling systems and process solutions support your worldwide manufacturing process reliably, quickly, and safely.
Whether you are filling aseptic liquids or powders, we integrate containment solutions such as isolators into any type of pharmaceutical processing system – including Material Transfer chamber lock, e-beam and sterilization tunnels and other components if required. What do we bring to the table? Patented technologies, a comprehensive understanding of your entire value chain, and the ability to listen to you carefully. When would you like to talk to us about an optimally integrated solution for your aseptic production?
The CSPE approach cuts delivery times and significantly speeds up the commissioning of pharmaceutical systems.
More than 30 years of experience give us a unique ability to develop, manufacture, qualify, and validate isolator technology specifically for you. We implement your technical requirements with our expertise. The objective is obvious: a replicable, reliable filling process. Protecting the product, the environment and the operating personnel is as much an integral part of every solution as rapid and repeatable decontamination. For the best possible material input and output, we manufacture isolators in compliance with cGMP.
Discover the applications for Optima Pharma isolatorsIn addition to isolators, RABS (Restricted Access Barrier Systems) are the most common barrier solution in pharmaceutical production. To prevent contamination in aseptic production, machine housings and interlocked doors separate the production area from the operating area; gloves are mandatory for any intervention. When properly operated as an integrated system, RABS technology can achieve the microbiological quality of an isolator.
The type of ventilation determines if you have an open or closed RAB system. Open RABS have a specific ventilation system, while closed RABS are docked to the ceiling of the class B cleanroom. If you want to improve your production quality and need a flexible containment solution, then consider closed RABS for your current cleanroom.
Whether isolator and tub transfer or freestanding, airlocks are used in various types of aseptic production to move material in and out while preventing contamination between cleanrooms. We offer high-quality solutions for all applications, as well as customized products.
An e-beam tunnel is used for surface decontamination of pre-sterilized tubs. How does it work? An electron accelerator (e-beam) sterilizes the tub surfaces before they enter the aseptic area. In the preceding step, the complete e-beam tunnel is decontaminated with gaseous hydrogen peroxide H2O2 – either separately or together with the isolator.
E-beam tunnels are becoming increasingly popular, as they are both reliable and cost-effective and ensure a high level of product safety when used in conjunction with isolator technology. We also offer a fully integrated production process, for example a turnkey solution for nested syringes using an e-beam tunnel.
E-beam tunnel overviewGloves pose a safety risk to the integrity of barrier systems: Even the smallest hole can be hazardous to the operator and the product. Therefore, glove testing systems are essential. Depending on your application, you can receive various systems for automated glove leak testing in a sterile environment:
Gas-tight doors are used in laboratories, as personnel locks, material locks, as well as for animal husbandry. A distinction is made between gas-tight doors with pneumatic or mechanical seals.
Doors with a pneumatic seal close particular tight. The seals can be easily replaced without removing or contaminating the door. Another advantage: Unlike doors with a mechanical seal, pneumatic doors do not require a threshold; the pneumatic control can be integrated into the building control system.
Doors with a mechanical seal do not require a control system. They can be opened and closed by hand. To close tightly, they need a threshold. Due to the specially developed locking mechanism, you can also use the doors between rooms with high differential pressure without the risk of warping.
When it comes to containment and protecting employees, isolators play an important role. That's why we design isolator technology for a wide range of applications – from classic sterility testing isolators and filling systems for small batches to individual turnkey systems for commercial production.
Whether for a filling line, loading and unloading system, or freeze-drying processes, we offer secure isolators for your entire production line. The objective is clear: Maximum yield while maintaining the highest hygiene standards. We achieve compliance and regulatory approval with patented isolator technology and automated and digitalized processes.
We have developed the STISO isolator for sterility testing and quality control. We make this sterility test isolator according to cGMP compliant design.
Isolators are increasingly used in laboratories. We can meet your specific requirements with special attachment and laboratory isolators. The focus of the application is to protect operating personnel during development and analyze activities performed in the isolator.
From production to filling, isolators play an important role in sensitive cell and gene therapy. We build automated, modular and versatile isolator-based machine platforms customized to meet these requirements. This means your products are processed and filled carefully and reliably.
Whether for a filling line, loading and unloading system, or freeze-drying processes, we offer secure isolators for your entire production line. The objective is clear: Maximum yield while maintaining the highest hygiene standards. We achieve compliance and regulatory approval with patented isolator technology and automated and digitalized processes.
We have developed the STISO isolator for sterility testing and quality control. We make this sterility test isolator according to cGMP compliant design.
More about STISO / STISOhpDECOpulse® is a new H2O2 bio-decontamination system with atomization-driven evaporation. It requires less H2O2 than similar solutions and significantly decreases your decontamination times. This development was presented with the Biotech Innovation Award.
DECOpulse® is a new H2O2 bio-decontamination system with atomization-driven evaporation. It requires less H2O2 than similar solutions and significantly decreases your decontamination times. This development was presented with the Biotech Innovation Award.