Worried about contamination risks and navigating complex cGMP regulations? Within the Körber Ecosystem, our aseptic processing solutions elevate your pharmaceutical production, as they can seamlessly be integrated into all other solutions, guaranteeing cGMP and GMP compliance and aseptic excellence through state-of-the-art isolator and cleanroom technologies. Partner with our experts for personalized compliance guidance and optimize your pharmaceutical and biopharmaceutical production.
Isolators & RABSLaminar air flow systemsMaterial transfer solutionsLaboratory servicesGMP compliance servicesGlove testing solutions
In the ever-evolving pharmaceutical landscape, streamlined processes and efficient solutions are paramount. Our strategic partnership with Franz Ziel empowers you to unlock powerful synergies.
The aseptic processing solutions seamlessly integrate, ensuring consistent aseptic conditions, efficient production, and simplified operation. Together we offer you a unified solution, eliminating the need for multiple vendors and complex integrations, saving you valuable time and resources.
Partner with our experts for personalized compliance guidance and optimize your pharmaceutical production.
Ensure aseptic conditions, operator safety, and regulatory compliance in pharmaceutical and biopharmaceutical production with our multi-layered aseptic processing solutions. We offer you various isolators and Restricted Access Barrier Systems (RABS) as well as cutting-edge laminar air flow systems and material transfer solutions. Within our portfolio you will find everything your production needs.
We offer you various isolators and Restricted Access Barrier Systems (RABS) for all your production requirements, whether for personnel or product protection or a combination of both - as standard or special designs.
Personal protection isolators enables personal protection for operators when handling toxic substances.
Personal protection is achieved through a barrier (isolator housing with gloves) between the operator and the product. A defined negative pressure inside increases safety of the operator.
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Isolators in a compact design with product protection as an enclosure for aseptic processes, e.g. filling, loading and unloading of freeze dryers. With a total height of 3,000 mm, no additional technical area is required. Product protection is achieved by a barrier (isolator housing with glove ports) between the operator and the product. Product safety is ensured by the laminar air flow system including controlled overpressure regulation.
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Isolators with product protection as a housing for aseptic processes, e.g., filling, loading and unloading of freeze dryers.
Product protection is achieved through a barrier (isolator housing with gloves) between the operator and the product.
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Isolators with product protection as a housing for aseptic processes, e.g. filling, loading and unloading of freeze dryers.
Product protection is achieved through a barrier (isolator housing with gloves) between the operator and the product.
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Features:
Sterility testing isolators with product protection for the sterility test under aseptic and optionally aseptic / toxic conditions. A Rapid Decon Hatch (RDH) can be connected as an option.
Product protection is achieved through a barrier (isolator housing with gloves) between the operator and the product. Product safety is achieved through the Laminar Air Flow System including a controlled overpressure control.
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Closed RABS as a housing for aseptic processes, e.g., filling, loading and unloading of freeze dryers. Product protection is achieved through a barrier (cRABS housing with gloves) between the operator and the product.
The product safety is created by the Laminar Air Flow System including a controlled overpressure control.
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Open RABS as a housing for aseptic processes, e.g., filling, loading and unloading of freeze dryers. Product protection is achieved by a barrier (oRABS housing with gloves) between the operator and the product.
Product protection is created by the Laminar Air Flow System (type: active oRABS).
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Our laminar air flow systems are designed for the pharmaceutical industry, and they provide a comprehensive solution: minimizing contamination risks for aseptic conditions, safeguarding personnel from airborne hazards, and optimizing temperature and humidity for product stability. Experience unwavering enhanced operator protection, streamlined compliance, and improved process efficiency.
LAF systems offer product protection for different sized work areas, e.g. Sampling, general process technology and sterile filling of pharmaceutical and related applications.
Product protection is achieved through targeted air flow. An unidirectional air flow streams vertically into the work area of the cabin and escapes into the surrounding area near the ground – airborne particles are captured and removed in a controlled manner.
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LAF downflow booth offer product and personal protection when weighing or sampling powdered substances. These conditions are achieved through targeted air circulation. An unidirectional air flow streams vertically into the work area of the downflow booth and is extracted near the floor – air-borne substances are recorded in a controlled manner.
The integrated exhaust system, which creates a slight negative pressure in the work area of the downflow booth, permanently protects the surrounding area from contamination. A connection of the air recirculation cabin to an on-site supply or exhaust air system is not necessary.
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Minimize contamination, maximize efficiency for both standard and custom-designed transfers between cleanroom zones. We offer solutions for both sterile and non-sterile material transfer, ensuring maximum flexibility. Our innovative containment technologies and expert support guarantee product integrity throughout the process.
The Rapid Decon Hatch enables the supply of materials into clean rooms or isolators under aseptic conditions. The material is decontaminated in the hatch by the integrated bio-decontamination system “FZ-BDS 12/60” with vH₂O₂ (evaporated hydrogen peroxide).
Rapid Decon Stations enable the offline decontamination of e.g. Monitoring material. The material is decontaminated in the station by the integrated bio-decontamination system, using vaporized hydrogen peroxide.
Then the material is transported in RTP containers e.g. to a filling machine. The RDS is particularly suitable for supplying filling processes in isolators with monitoring material in campaign operations.
LAF transport trolleys with network-independent battery operation offer product protection and enable transport under aseptic conditions through inferior clean rooms, e.g., manual freeze dryer loading.
Hot air sterilization tunnels continuously depyrogenate pharmaceutical glass objects, e.g. B. vials, syringes, after washing in a washing machine and before entering a filling machine.
The tunnels consist of an entry zone, the sterilization zone and the cooling zone with a corresponding pressure cascade between the zones. The electrical control is integrated for a compact design.
Simplify compliance processes for a faster route to market with our team of experts. We can offer you comprehensive support, leveraging both in-depth knowledge of GMP principles and extensive practical experience for an improved aseptic processing.
Uncertainty about FDA/GMP compliance in bio-decontamination? Our expert cycle development ensures regulatory adherence and effectiveness, minimizing risks and maximizing peace of mind.
Guarantee project success with comprehensive GMP compliance support. Our team of experts tackles every aspect, from facility design to aseptic containment strategies. Ensure scientific excellence and seamless integration – all while adhering to the strictest GMP regulations.
Fast-track your project timelines with our expert guidance, ensure flawless compliance for regulatory peace of mind, optimize your R&D processes for scientific excellence, and achieve seamless integration for efficient production workflows.
Improve your glove testing with our latest Glove Testing System (GTS). This innovative system delivers unmatched flexibility to adapt to your testing needs, seamlessly integrating with existing workflows for increased efficiency.
Experience faster throughput with multiple glove testing via WLAN, all while maintaining unwavering compliance (GAMP 5 & CFR 21 Part 11). Our latest Glove Testing System ensures complete traceability with a comprehensive audit trail and streamlines batch reporting for simplified documentation.
Reduced downtimes
Small footprint
Always compliant