Robotic aseptic filling for gloveless Annex 1-compliant lines
Reduce Grade A interventions with SynTiso, a gloveless, fully automated commercial fill & finish line designed to meet Annex 1 expectations.
SynTiso is engineered for zero-glove operations
Annex 1 expectations, glove-based interventions and capacity targets increase challenges in robotic aseptic filling. As your strategic lifecycle partner, Syntegon applies SynTiso as a fully automated, gloveless commercial fill & finish line with 100% IPC designed to help meet Annex 1 expectations and re:imagine your aseptic production.
Remove human touchpoints, align with Annex 1, scale with documented quality
How to align with Annex 1 in Grade A?
Addressing EU GMP Annex 1 drives elimination of gloves, automated aseptic set-up and controlled first-pass air.
To meet this, SynTiso combines a gloveless isolator, integrated air handling and clear separation of aseptic and technical areas in an Annex 1-compliant design.
- Gloveless isolator with integrated air handling
- UDAF-friendly first-pass air aseptic design
- Clear separation of aseptic and technical areas
- Annex 1-compliance from the beginning
How to eliminate glove interventions at critical points?
Operating without gloves demands precise robotic handling and automated aseptic set-up in the Grade A core. In response, SynTiso uses a gloveless isolator, robot-driven aseptic set-up functions and fully automated solutions to keep production running.
- Gloveless isolator with integrated air handling and fully automated production processes
- Automated aseptic set-up functions
- Advanced cleanability with fast biodecontamination
- Robot-driven interventions
How to raise throughput with documented quality?
Commercial output targets of up to 600/min increase the need for documented quality at line speed. As a result, SynTiso combines up to 600/min output with fully automatic 100% IPC and innovative frictionless transport that eliminates particle generation and glass-to-glass contact.
- Up to 600/min with fully automatic 100% IPC
- No wear of main transport element
- RTU syringes, vials and cartridges on one platform
- Up to 35% higher net unit production
SynTiso overview
RTU infeed and biodecontamination
Integrate bag and tub openers with short biodecontamination cycles to prepare RTU nests.
Gloveless isolator
Support Grade A conditions with a gloveless isolator, integrated air management and fast biodecontamination cycles.
Automated aseptic set-up, robotic handling and filling
Run fully automated robotic handling for filling and closing to stabilize aseptic processing after an automated aseptic set-up.
Frictionless transport
Use frictionless transport that eliminates particle generation and glass-to-glass contact in the aseptic core.
100% IPC and reject segregation
Apply fully automatic 100% IPC at speed with a reject station for documented quality.
RTU format flexibility
Process syringes, vials and cartridges on one platform with rapid size part only changeover.
RackSter for faster batch changeover
Bring sterilized parts to the SynTiso line with RackSter, our mobile sterilization and transfer system.
RTU infeed and biodecontamination
Integrate bag and tub openers with short biodecontamination cycles to prepare RTU nests.
Gloveless isolator
Support Grade A conditions with a gloveless isolator, integrated air management and fast biodecontamination cycles.
Automated aseptic set-up, robotic handling and filling
Run fully automated robotic handling for filling and closing to stabilize aseptic processing after an automated aseptic set-up.
Frictionless transport
Use frictionless transport that eliminates particle generation and glass-to-glass contact in the aseptic core.
100% IPC and reject segregation
Apply fully automatic 100% IPC at speed with a reject station for documented quality.
RTU format flexibility
Process syringes, vials and cartridges on one platform with rapid size part only changeover.
RackSter for faster batch changeover
Bring sterilized parts to the SynTiso line with RackSter, our mobile sterilization and transfer system.
Explore the complete line
Explore SynTiso for robotic aseptic filling
Explore SynTiso for robotic aseptic filling
Frictionless transport eliminating particles and glass-to-glass contact, with no wear of main transport element
Best if you want:
- Gloveless, fully automated RTU line with 100% IPC up to 600/min
- Up to 35% higher net unit output
Annex 1-compliant commercial speed gloveless robotic aseptic filling with 100% IPC
- Eliminate gloves in Grade A for superior contamination control
- Reach up to 600/min with fully automated 100% in-process control
- Recover availability with fast biodecontamination and up to 50% faster batch changeovers
What sets SynTiso apart
Gloveless isolator with integrated air management
SynTiso combines a gloveless isolator, integrated air management and a single platform machine + isolator unit. This reduces surrounding interfaces and supports Grade A conditions without glove ports. The integration approach becomes tangible in the features below.
- Purpose-built approach with integrated air management
- Reduced interfaces to the building
- Single-platform machine and isolator unit
- Fast installation and validation
Fully automated robotic processing with 100% IPC
SynTiso gloveless, fully automated line reaches up to 600/min with fully automatic 100% in-process control. That keeps verification at line speed and strengthens documented quality at commercial output. The control concept becomes clear in the features below.
- Fully automatic 100% IPC
- Re-dose on request functionality
- Dose-in / dose-out possible
- Reject station
RTU flexibility and faster changeovers
Syntegon’s innovative frictionless transport eliminates glass-to-glass contact and removes wear from the main transport element. That protects container handling at speed and reduces disruption in the aseptic core.
- No particles or wear of main transport element
- Advanced cleanability with fast biodecontamination
- Fast batch changeover up to 50% faster than traditional lines
- RTU container-type flexibility: syringes, vials and cartridges
Eliminate trade-offs in aseptic filling with SynTiso
Get faster, cleaner, higher-yield production without compromise — SynTiso’s gloveless RTU line offers full automation, up to 600/min with 100% IPC, faster changeovers up to 50% and up to 35% more net units.
SynTiso knowledge hub
Explore SynTiso – the next evolution.
Learn about our commercial speed gloveless isolator, automated aseptic set-up, and much more.
Explore all RTU filling machines
Get an in-depth overview of advanced RTU filling solutions designed for syringes, vials, and cartridges.
Frequently asked questions
SynTiso applies fully automated robotic handling inside a gloveless isolator with integrated air management. The line employs 100% in process control while processing RTU syringes, vials and cartridges. The gloveless design eliminates manual touchpoints and aligns with Annex 1 expectations for minimized human intervention in Grade A.
Measures include operating without gloves in Grade A, automated aseptic set up after biodecontamination, UDAF friendly first pass air and clear separation of aseptic and technical areas. Integrated air management supports stable conditions and contamination control across the line. These design choices align with Annex 1 expectations and support your contamination control strategy (CCS).
SynTiso removes glove ports and uses robotic handling for set up and processing. Combined with integrated air management and first pass air, this reduces contamination routes in the aseptic core and supports Grade A conditions without routine glove interventions.
SynTiso achieves up to 600 containers per minute with fully automatic 100% in‑process control. Container‑level checks occur at line speed, and a reject station is available to segregate nonconforming units without disrupting flow.
SynTiso covers RTU syringes, vials and cartridges. Typical ranges include vials 2R–50R, syringes 0.5–20 ml and cartridges 1–20 ml, depending on configuration. This breadth lets teams handle common formats on one platform.
The transport system eliminates glass to glass contact, which supports gentle handling at speed and reduces mechanical wear. This frictionless transport strategy strengthens consistency in the aseptic core at commercial throughput.
By eliminating glove ports and other design improvements, batch changeovers are up to 50% shorter versus traditional lines. Sites also see up to 35% higher net unit production when this approach is applied, supporting capacity goals.
SynTiso pairs fully automatic 100% IPC with a reject station. Out‑of‑tolerance containers are removed immediately, which sustains documented quality and keeps the line running at planned speed.
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Customer or industry overcomes challenge with Syntegon
First sentence: Clearly describe the customer's challenge or problem. Second sentence: Explain how Syntegon’s solution effectively addressed the issue.
Customer or industry overcomes challenge with Syntegon
First sentence: Clearly describe the customer's challenge or problem. Second sentence: Explain how Syntegon’s solution effectively addressed the issue.
Customer or industry overcomes challenge with Syntegon
First sentence: Clearly describe the customer's challenge or problem. Second sentence: Explain how Syntegon’s solution effectively addressed the issue.