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Pharma and Biotech
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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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At Optima Pharma, we always prioritize protecting the product, staff and the environment in the manufacturing process. Our pharmaceutical filling systems and turnkey process solutions are designed to deliver fast, safe and reliable support for your global manufacturing processes. Whether you are filling aseptic liquids or powders, we can integrate containment solutions like pharmaceutical isolators into any type of processing system, including material transfer chamber locks, e-beam sterilization tunnels and other components as 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. Get in touch so we can find the perfect integrated solutions for your aseptic production together.
The CSPE approach cuts delivery times and significantly speeds up the commissioning of pharmaceutical systems.
Interest in isolators for pharmaceutical applications is growing around the world. With over 30 years of experience in developing, manufacturing, qualifying and validating pharmaceutical isolators, we are the perfect partner for you. Our isolators comply with cGMP and ensure the best possible material input and output. Most importantly, we make sure that every system we produce protects the product, the environment and your staff.
Discover the applications for Optima Pharma isolators
Pharmaceutical isolators play an important role in containment and protecting employees. That is why we design a wide range of isolators for pharmaceutical applications – from classic sterility testing isolators and filling systems for small batches to individual turnkey systems for commercial pharmaceutical manufacturing. Here are just some of the areas in which Optima Pharma isolators are used:
The STISO isolator is developed for sterility testing and quality control, and is designed in line with cGMP.
The STISO isolator is developed for sterility testing and quality control, and is designed in line with cGMP.
More about STISO / STISOhp
DECOpulse is our innovative H2O2 bio-decontamination system that uses atomization-driven evaporation. It requires less H2O2 than similar solutions and significantly reduces decontamination times. This protects your materials and keeps your processes, operating personnel and products safe. We are proud to have received the Biotech Innovation Award for this development.
DECOpulse is our innovative H2O2 bio-decontamination system that uses atomization-driven evaporation. It requires less H2O2 than similar solutions and significantly reduces decontamination times. This protects your materials and keeps your processes, operating personnel and products safe. We are proud to have received the Biotech Innovation Award for this development.
In addition to pharmaceutical isolators, we offer a range of complementary containment solutions tailored to meet various requirements in pharmaceutical manufacturing:
In 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 overview
Gloves 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.
