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Isolator and containment technology

Pharma and biotech: Equipment for your aseptic cleanroom production

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?

Two assemblers at a pharmaceutical machine
Opened door of an isolator
Assembler at a glove of a pharmaceutical machine
Isolator with gloves
Assembler installing gloves at a pharmaceutical machine
Pharmaceutical machine view with isolator
Gerhard Breu
Gerhard Breu, Chairman, Optima Pharma Division

The CSPE approach cuts delivery times and significantly speeds up the commissioning of pharmaceutical systems.

Gerhard Breu, Chairman, Optima Pharma Division
Pharma Turnkey SolutionPharma Turnkey Solution
Integrated turnkey solutions with a CSPE approach

Time-to-market is becoming increasingly important in the pharmaceutical and biotech sectors. To ensure a quick and safe start to production, we rely on the CSPE approach. Short for Comprehensive Scientific Process Engineering, CSPE accelerates the development and construction of your system with the help of digital engineering, simulation, virtual reality, and an integrated Factory Acceptance Test, or iFAT for short.

In many parts of the world, interest in isolator technology is increasing and therefore, in total solutions from Optima Pharma. As a system provider for integrated filling and process solutions, we are a global partner to the pharmaceutical industry: We design and build turnkey lines with complete filling and closing technology, containment, and freeze dryers – platform-based and tailored to your specific needs. 

Whether barrier systems such as RABS or isolators, glove testing systems, gas-tight doors, airlocks, or e-beam tunnels, we offer you a comprehensive, modular product portfolio combined with expertise and holistic service. Minimize your start-up time with Optima!

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An overview of the product portfolio
Whatever you have in mind – we have the solution!
Mechanic closes a door on an isolator with glove intervention

Isolators

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 isolators

RABS

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. 

Gloves at a pharmaceutical machine
Bag feed into a pharmaceutical machine

Airlocks

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.

E-beam tunnel

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 H2O – 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
E-Beam tunnel
Glove at an isolator

Glove testing systems

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:

  • Mobile glove testing system: Flexible, reliable and easy to operate – with WLAN capability for more convenience
  • Integrated glove testing system: Reliable and easy to use 

Gas-tight doors

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.

Gasproof door
Experts for isolator and biodecontamination
Do you have questions about the individual containment products or would you like to discuss your specific needs with our experts?
Experts for isolator and biodecontamination
OPTIMA pharma containment GmbH
+49 7738 9280-0 customer.info@optima-packaging.comWrite e-mail
Experts for isolator and biodecontamination
Experts for isolator and biodecontamination
OPTIMA pharma containment GmbH
Isolator application areas
Isolator technology for every situation

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.

  • Production isolator
  • Sterility test isolator
  • Attachment and laboratory isolator
  • Cell and gene therapy isolators
Next
Isolator with gloves
Production isolator

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.

Pharmaceutical machine in production
Sterility test isolator

We have developed the STISO isolator for sterility testing and quality control. We make this sterility test isolator according to cGMP compliant design.

simulation of ergonomy at glove handles
Attachment and laboratory isolator

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.

OPTIMA PRO CELL 2000
Cell and gene therapy isolators

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.

Production isolator
Isolator with gloves

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.

Sterility test isolator
Pharmaceutical machine in production

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 / STISOhp
Attachment and laboratory isolator
simulation of ergonomy at glove handles

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.

Cell and gene therapy isolators
OPTIMA PRO CELL 2000

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.

DECOpulse® technology Isolator decontamination more quickly and gently

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.

Speed reduces production time
Less H2O2 protects your materials
Safety for processes, operating personnel, and products
Scalable to meet your needs
Patented, unique solution
General view of machine with snow background
DECOpulse® technology Isolator decontamination more quickly and gently

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.

Speed reduces production time
Less H2O2 protects your materials
Safety for processes, operating personnel, and products
Scalable to meet your needs
Patented, unique solution
General view of machine with snow background
Experts for isolator and biodecontamination
Do you have any questions about the sterility test isolator, or would like to discuss your requirements with our experts? We look forward to hearing from you.
Experts for isolator and biodecontamination
OPTIMA pharma containment GmbH
Experts for isolator and biodecontamination
Experts for isolator and biodecontamination
OPTIMA pharma containment GmbH
+49 7738 9280-0 Write e-mail
More about this topic Success stories about isolators and containment solutions
Matthias Aster
Do you have questions about the individual containment products or would you like to discuss your specific needs with our experts?
Experts for isolator and biodecontamination
OPTIMA pharma containment GmbH
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