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    Pharmaceutical isolator and RABS barrier systems

    Reduce contamination risk and human interventions in aseptic filling. 

    Connect with isolator experts See isolator downloads

    Choose pharmaceutical isolator and RABS concepts under Annex 1

    Pharmaceutical isolator and RABS barrier systems are the protective housing arround aseptic filling projects. Annex 1 expectations, sterility risks and lifecycle costs make each barrier concept decision a high-stakes tradeoff. Syntegon helps you compare RABS and isolator concepts and design solutions that support Annex 1 focused reviews. 

    Pharmaceutical isolator and RABS systems: fewer interfaces, stronger OEE

    How to cut interfaces on isolator and RABS filling lines?

    Rely on one partner for integrated isolator and RABS lines.

    How to shorten ramp-up and cut unplanned isolator line stops?

    Use lifecycle support that speeds qualification and stabilizes line uptime.

    How to improve OEE and control energy use in barrier lines?

    Pair barrier concepts with designs that support OEE and energy goals.

    Compare pharmaceutical isolator and RABS options

    Overall 4 Solutions
    Sterility assurance level
    High potent capability
    Typical campaign profile
    Operator convenience
    Investment and running costs
    Surrounding cleanroom grade
    Integrated bio-decontamination
    Air maintenance
    Benefits
    High potent isolator line
    Sterility assurance level
    Highest: operator & product
    High potent capability
    Yes
    Typical campaign profile
    Ideal for longer campaigns with the same product
    Operator convenience
    Convenience due to high automation level
    Investment and running costs
    CAPEX higher, OPEX lower
    Surrounding cleanroom grade
    Grade C room
    Integrated bio-decontamination
    Yes
    Air maintenance
    Tailored to customer requirements
    Benefits

    Best if you want:

    • Isolator for high potent or BSL products 
    • Top sterility level with Grade C surroundings 
    Aseptic isolator line
    Sterility assurance level
    Higher: operator & product
    High potent capability
    No
    Typical campaign profile
    Ideal for longer campaigns with the same product
    Operator convenience
    Convenience due to high automation level
    Investment and running costs
    CAPEX high, OPEX lower
    Surrounding cleanroom grade
    Grade C room
    Integrated bio-decontamination
    Yes
    Air maintenance
    Tailored to customer requirements
    Benefits

    Best if you want:

    • Barrier line for aseptic products
    • Long campaigns with lower running costs in Grade C
    Closed RABS line
    Sterility assurance level
    Higher: operator & product
    High potent capability
    Yes
    Typical campaign profile
    Ideal for longer campaigns with the same product
    Operator convenience
    More manual interventions
    Investment and running costs
    CAPEX high, OPEX higher
    Surrounding cleanroom grade
    Grade B room
    Integrated bio-decontamination
    No
    Air maintenance
    -
    Benefits

    Best if you want:

    • Closed RABS where high potent use is needed
    • Longer campaigns in Grade B with manual access options
    Open RABS line
    Sterility assurance level
    High: operator & product
    High potent capability
    No
    Typical campaign profile
    Made for shorter campaigns, ideal for multiproduct manufacturing
    Operator convenience
    More manual interventions
    Investment and running costs
    CAPEX medium, OPEX higher
    Surrounding cleanroom grade
    Grade B room
    Integrated bio-decontamination
    No
    Air maintenance
    -
    Benefits

    Best if you want:

    • Flexible barrier for frequent changeovers 
    • Multiproduct aseptic manufacturing in existing Grade B rooms 
    Featured_Download_Teaser_BarrierSystem

    Plan isolator and RABS projects with confidence

    Get an overview of Syntegon isolator and RABS options.

    • Compare layouts and barrier concepts
    • Match setups to aseptic and high potent use
    • Plan services, air handling and upgrades
    Download

    Pharmaceutical isolator highlights

    1080x1080_TechnologyIsolator

    <60 min H2O2 biodecontamination per isolator cycle

    Short H2O2 cycles free capacity and simplify campaign planning.
    1080x1080_SyntisoFrosted

    Fewer glove interventions with gloveless isolator concepts

    Reduce glove use and support stable microBatch and SynTiso filling.
    1080x1080_IntegratedHandling

    In-air isolator cuts HVAC footprint and interfaces

    Integrate air handling in the isolator to save space and reduce HVAC interfaces.

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    Your strategic lifecycle partner for barrier systems

    service-life-cycle
    Process and cycle development for isolators

    We optimize filling and bio-decontamination parameters so your isolator lines reach stable, efficient cycles in routine production. 

    Learn more
    service-life-uptime
    Qualification and validation for barrier systems

    We support qualification, risk assessments and rationales so Annex 1 focused isolator projects gain clear, documented justification. 

    Learn more
    service-future-ready
    Lifecycle service for isolators and RABS lines

    From first FAT to upgrades, Syntegon stays at your side to keep barrier lines available, compliant and ready for audits. 

    Learn more

    Pharmaceutical isolator knowledge hub for engineers

    Barrier system design guide for BSL fill finish
    Barrier system design guide for BSL fill finish

    Learn how to select cRABS or isolators for BSL-2+ products and design pressure zones, filters and H2O2 inactivation.

    Download
    Avoiding product oxidation by H2O2 in isolators
    Avoiding product oxidation by H2O2 in isolators

    Understand how residual H2O2 affects sensitive biologics and how studies, sensors and process design.

    Download
    H2O2 biodecontamination cycles for isolators
    H2O2 biodecontamination cycles for isolators

    See how SafeVAP concepts shorten isolator biodecontamination cycles and what this means for daily filling capacity.

    Download
    Barrier system brochure
    Barrier system brochure

    Get an overview of Syntegon isolator and RABS options.

    Download
    1080x1080_SynTiso
    INNOVATION SPOTLIGHT

    SynTiso gloveless isolator for Annex 1 compliance

    Remove glove ports as a contamination source with a gloveless isolator that supports Annex 1 expectations. 

    Explore SynTiso gloveless isolator

    Frequently asked questions

    Start from product risk, campaign length, retrofit needs and Annex 1 expectations. Isolators offer strict physical separation, automated H2O2 biodecontamination and often allow lower surrounding room grades. Open or closed RABS can fit existing high grade cleanrooms and high mix production when procedures and training are very strong. Syntegon supports early concept studies and risk assessments for both options.

    Barrier systems overview

    High potent APIs up to OEB 6 and biosafety level 2 or higher products usually need closed barrier systems that protect operators and the environment. For BSL 2 and above, a closed RABS or isolator around filling, lyophilization and capping helps keep biohazardous material inside the barrier. Syntegon designs isolators and cRABS specifically for these applications. 

    Biodecontamination time directly reduces available filling time per shift. Long cycles limit daily output and campaign flexibility. With integrated SafeVAP systems, Syntegon isolators can reach complete cycles of less than 60 minutes to 1 ppm on fully loaded commercial lines, and around 20 minutes on small transfer isolators, depending on load. Short, validated cycles make planning easier and support more campaigns per year. 

    Download whitepapers

    Yes, but residual H2O2 and exposure time must match product tolerance. Some sensitive biotherapeutics may require residual levels down to about 0.03 ppm, which can extend aeration time. Syntegon and partners use uptake and spiking studies together with very sensitive sensors to link airborne and dissolved H2O2, then tailor cycles and materials. This helps protect product quality while keeping downtime manageable.

    Open and closed RABS usually require at least a Grade B or ISO 7 environment in operation, since the room still supports the Grade A core. Isolators can often run with adjacent rooms at ISO 8, for example A in C layouts. This can reduce room size, HVAC demand and gowning effort. Final room classes always follow the specific process and regulatory requirements. 

    Integrated air management places key air handling functions in or directly above the isolator instead of in separate technical rooms. This can remove external air handling units on the equipment floor, reduce ducting and free technical space. Syntegon in‑air isolator concepts combine barrier, H2O2 system and air handling so engineers face fewer interfaces and simpler installation and service. 

    Syntegon supports barrier systems from early design through long term operation. Services include CFD simulations, H2O2 and wash in place optimization, loading concepts for transfer airlocks, development of glove test parameters, as well as qualification, validation and risk analysis. Dedicated lifecycle service, spare parts and modernization help keep aseptic and containment lines stable and ready for audits. 

    Syntegon offers qualification and validation support for complete isolator and RABS lines. This includes defining test strategies, developing and optimizing biodecontamination cycles, supporting glove integrity testing and preparing risk based rationales for critical design choices. The goal is to provide clear documentation and data so Annex 1 focused inspections run more smoothly and rework during reviews is reduced. 

    Annex 1 solutions

    Yes. Syntegon designs isolators and cRABS for BSL applications using pressure zoning, double wall designs, SafeVAP inactivation cycles and safe filter concepts. A Bavarian Nordic case shows how pressure cascades, dedicated H2O2 inactivation cycles and outside cleaning machines protect operators and products during BSL 2 vaccine filling and freeze drying. Concepts are tailored to each product and facility.

    Syntegon supplies a wide range of peripheral equipment. Examples include cleaning machines, fast H2O2 transfer chambers, rapid transfer port based transfer systems, glove testing devices, vacuum cleaners for aseptic areas and filter scanning systems for automatic HEPA integrity checks. Engineers can source filling, barrier, transfer and supporting equipment from one partner to simplify integration and service. 

    Interested in our pharmaceutical isolator?

    Interested in our pharmaceutical isolator?

    Talk to a Syntegon expert to learn more about pharmaceutical isolators.

    Learn more

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