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    Lifecycle partnership: Annex 1 compliance for new and existing lines

    One accountable partner for Annex 1: assess, implement, qualify and optimize across your aseptic line.

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    Annex 1 compliance in practice across your aseptic line

    Annex 1 interpretations differ across the globe and some challenges are yet not paired with concrete interpretations by authorities.

    As your lifecycle partner, Syntegon assesses gaps, implements and qualifies solutions across e.g., first air, environmental monitoring, PUPSIT and aseptic setup to align operations with current Annex 1 expectations. 

    First air, aseptic setup and operator separation for Annex 1

    How to protect first air at critical points?

    Avoid interruptions of first air and keep sterilizable parts easy to transfer.

    How to perform a compliant aseptic setup of filling and stoppering?

    Tools, retrofits and easy-to-handle solutions

    How to get my operators separated from aseptic processes?

    RABS retrofits and advanced transfer technology for isolators.

    Annex 1 retrofit priorities across your aseptic filling line

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    Gap analysis and roadmap

    Assess Annex 1 gaps, rank retrofit actions and align shutdown windows before implementation.

    RABS upgrade

    Add physical separation and advanced transfers with open or closed RABS to protect aseptic processing on existing lines.

    Transfer and glove concept

    Redesign glove ports, RTPs and transfer paths to cut entries into critical zones.

    Automated environmental monitoring

    Automated change of passive and active viable monitoring to avoid interventions.

    PUPSIT retrofit

    Integrate recipe-driven PUPSIT at existing lines with full records in the batch protocol.

    Learn more

    Qualification and modernization

    Combine retrofit execution with IQ/OQ and modernization work to shorten the path to implementation.

    Autoclave air detector

    Align vacuum-steam sterilizers with Annex 1 expectations using a fully automatic, integrated air detector system for porous load sterilization cycles.

    ALF_mit_Telstar_FD_2

    Gap analysis and roadmap

    Assess Annex 1 gaps, rank retrofit actions and align shutdown windows before implementation.

    ALF_mit_Telstar_FD_2

    RABS upgrade

    Add physical separation and advanced transfers with open or closed RABS to protect aseptic processing on existing lines.

    ALF_mit_Telstar_FD_2

    Transfer and glove concept

    Redesign glove ports, RTPs and transfer paths to cut entries into critical zones.

    ALF_mit_Telstar_FD_2

    Automated environmental monitoring

    Automated change of passive and active viable monitoring to avoid interventions.

    ALF_mit_Telstar_FD_2

    PUPSIT retrofit

    Integrate recipe-driven PUPSIT at existing lines with full records in the batch protocol.

    Learn more
    ALF_mit_Telstar_FD_2

    Qualification and modernization

    Combine retrofit execution with IQ/OQ and modernization work to shorten the path to implementation.

    ALF_mit_Telstar_FD_2

    Autoclave air detector

    Align vacuum-steam sterilizers with Annex 1 expectations using a fully automatic, integrated air detector system for porous load sterilization cycles.

    Explore the complete line

    Gap analysis
    RABS
    Transfer
    Automated environmental monitoring
    PUPSIT retrofit
    Qualification and modernization
    Autoclave air detector
    Featured_Download_Teaser_BarrierSystem

    Plan your RABS retrofit with confidence

    How to upgrade traditional aseptic lines with barrier technology

    • Compare open and closed RABS
    • Plan transfer ports and glove access
    • Define monitoring and retrofit scope
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    Expert Annex 1 support from assessment to qualification

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    Neutral Annex 1 gap assessment across your entire aseptic factory

    Independent (3rd party) Annex 1 assessments across your entire aseptic factory, not just Syntegon equipment.
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    Tailored engineering where standard upgrades are not enough

    Custom Annex 1 solutions for complex or non-standard retrofit challenges on any equipment.
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    IQ/OQ delivered alongside your retrofit

    Qualification documentation and on-site execution combined with modernization work.
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    Case Study

    AJ Vaccines upgrades an MLF 3002 for Annex 1

    Facing new Annex 1 barrier expectations, AJ Vaccines upgraded an existing vial filling line instead of replacing it.

    See how Syntegon combined audit, mock-up work and a passive open RABS to modernize the machine.

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    Innovative Technologies We enable market leadership.
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    Innovation Spotlight

    SynTiso: gloveless, fully automated fill & finish for Ready-to-Use packstyles

    SynTiso is a gloveless, fully automated, consistent Annex 1 compliant commercial fill and finish line with 100% IPC. It eliminates operator interventions in the critical zone by combining advanced isolator technology with end-to-end filling and closing automation for conherent contamination control at commercial scale.

    Explore SynTiso

    Your strategic lifecycle partner for Annex 1

    service-life-cycle
    Ready for everything, from start to routine

    From installation to optimization, Syntegon supports you with structured service packages, training, and specialists – for safe, stable and resilient production across the lifecycle.

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    service-life-uptime
    Secure availability – every day

    Fast spare parts, qualified support and preventive maintenance help you avoid unplanned downtime, protect performance and keep daily operations reliable.

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    service-future-ready
    Make your line fit for tomorrow

    Scalable retrofits, data solutions and handling/automation systems help you adapt to new demands, improve OEE and keep your lines future-proof across changing requirements.

    Learn more

    Annex 1 resources for every step of your project

    Filter Test Rack Brochure
    Filter Test Rack Brochure

    Discover how automated Filter Test Racks performs PUPSIT on single use filtration kits and record filter integrity tests directly in the batch protocol of the filling machine.

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    RABS retrofit
    RABS retrofit

    Meet the new requirements by retrofitting your existing equipment with our RABS.

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    Viable monitoring: Automated change of settle plates
    Viable monitoring: Automated change of settle plates

    Retrofit Settle Plate Changer

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    Vacuum steam sterilizers for equipment and components
    Vacuum steam sterilizers for equipment and components

    Understand vacuum steam cycles with evacuating, heating, sterilizing, drying and venting steps for equipment and porous loads.

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    Frequently asked questions

    Not necessarily. Annex 1 recommends barrier systems and reduced manual interventions but does not mandate new equipment from the scratch. Many existing lines can be upgraded with RABS retrofits, automated monitoring and improved transfer concepts. A structured gap assessment helps define whether a retrofit or replacement is the right path for your specific line and audit timeline. 

    PUPSIT stands for pre-use post-sterilization integrity testing. The 2023 revision of EU GMP Annex 1 strengthens expectations for filter integrity testing and recommends PUPSIT as best practice. For the European market, alternatives may be accepted with a robust, documented risk assessment and additional controls. Automated PUPSIT reduces operator dependency and records results directly in the batch protocol. 

    A contamination control strategy maps risks across the full line, from supply chain, barrier design and aseptic setup to environmental monitoring, transfer concepts and personnel interventions. Annex 1 expects a documented, risk-based approach. Starting with a gap assessment helps define which areas require immediate action and which can be addressed in planned shutdown windows. 

    First air refers to unidirectional airflow that reaches product-contact surfaces before any obstruction. Annex 1 expects equipment and process design to protect first air at e.g., needles, stoppers and open containers. Glove interventions, poor component positioning or inadequate barrier design can all disrupt first air and increase contamination risk. 

    Manual interventions in Grade A increase contamination exposure and add operator-dependent risk to the EM record. Key measures include automating settle plate handling, using RTPs and airlocks for material transfer, redesigning glove port positions and defining aseptic setup procedures that avoid blocking critical airflow paths. 

    An open RABS uses the room HVAC for air supply and allows controlled opening of the barrier for interventions under defined conditions (commonly for (planned) routine interventions doors have to stay closed). A closed RABS is a fully sealed system with its own air handling unit and is typically used for higher-containment applications or highly potent products. Both variants can be configured as active or passive depending on the ventilation approach  

    Automated viable monitoring systems replace manual settle plate handling inside the barrier. They store plates in a magazine, expose them at the sampling position for the required interval and return them without operator entry. This extends change intervals to at least 24 hours, reduces manual interventions and standardizes exposure data for the monitoring record. 

    Start with a structured maturity check that scores your line across barrier systems, first air, aseptic setup, PUPSIT and EM programs. Map the findings against your next audit date and planned shutdown windows. That gives you a ranked action list aligned to implementation reality rather than a theoretical compliance checklist.

    Interested in our pharma solutions?

    Interested in our pharma solutions?

    Contact our experts to learn more about Syntegon’s processing and packaging solutions.

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