Pharmaceutical isolators and containment solutions
Optima Pharma always prioritize protecting the product, staff and the environment in the manufacturing process. The pharmaceutical filling systems and turnkey process solutions are designed to deliver fast, safe and reliable support for global manufacturing processes. Whether its filling aseptic liquids or powders, Optima 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. Patented technologies, a comprehensive understanding of the entire value chain and the ability to listen to it carefully.
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, Optima relies 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, Optima is 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 specific needs.
Whether barrier systems such as RABS or isolators, glove testing systems, gas-tight doors, airlocks, or e-beam tunnels, Optima offer you a comprehensive, modular product portfolio combined with expertise and holistic service.
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, Optima has the best competency. Optima 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 the staff.
- Production isolator
Secure isolators for the entire production line, whether for filling lines or loading and unloading systems.
- Sterility test isolator
The STISO isolator is developed for sterility testing and quality control, and is designed in line with cGMP.
Product safety is a top priority when filling pharmaceutical products. A sterility test isolator ensures batch sterility.
The STISO is a modular design, customized to your production needs and speeds-up batch release.
Benefits
- Effective material transfer
- Stable sterility tests
- Protection of product, environment and operating staff
- Fast reproducible decontamination
- cGMP-compliant design
Plug-and-test isolator STISO
The STISO sterility test isolator is ideal for aseptic (STISO) and aseptic-high-potency (STISOhp) applications, such as:
- Sterility tests
- Quality controls
- Weighing and pre-dissolving highly active substances
Why STISO ?
- Plug & test: pre-configured system for quick start-up
- Optimal operational ergonomics: Ergonomically located glove ports.
- Modular design: For flexible applications.
- Temperature control: Inside the work space due to an integrated cooling system.
- Wireless glove testing system: Mechanical, integrated on the side of the housing; pre-installed test software in the HMI.
- Contamination-free exchange of air recirculation filter: Maintenance without any additional protective measures.
- Attachment and laboratory isolator
Special isolators for laboratory use, focusing on protecting operating personnel during development and analysis.
- Cell and gene therapy isolators
Automated, modular and versatile isolator-based machine platforms customized for sensitive cell and gene therapy processes.
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 the materials and keeps processes, operating personnel and products safe. Optima received the Biotech Innovation Award for this development.
- Speed reduces production time
- Less H2O2 protects your materials
- Safety for processes, operating personnel, and products
- Scalable to meet your needs
- Patented, unique solution
In addition to pharmaceutical isolators, Optima offer a range of complementary containment solutions tailored to meet various requirements in pharmaceutical manufacturing:
- 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 there is 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 current cleanroom.
- 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. Optima 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 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. Optima also offer a fully integrated production process, for example a turnkey solution for nested syringes using an e-beam tunnel.
- 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 the application, 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, doors between rooms with high differential pressure can be used without the risk of warping.
