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ALF 5000 V _11_V2

Vial filling machines for Annex 1 compliant line solutions

One line, any vial, with maximum flexibility for Annex 1 compliant aseptic production.

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Keep vial filling lines flexible across batches and formats

Syntegon vial filling machines are part of end-to-end, seamlessly integrated lines that adapt to changing vial formats, batch sizes, and containment concepts.

Our equipment enables rapid format changes, multiproduct processing, and simpler (re-)validation through integrated isolator, freeze-drying, and inspection solutions. With more than 1,500 installations worldwide, we help you boost capacity while staying flexible, efficient, and fully regulatory ready.

Vial filling machines: flexibility, compliance and dosage range

How to combine vial line flexibility and speed?

Flexible vial filling lines stay fast from small to large batches.

How to design vial filling lines for Annex 1 compliant operations?

Aseptic vial filling lines with barriers and inspection support Annex 1 needs.

How to handle different dosage forms on one vial line?

One vial filling line handles liquid, lyophilized, oily and viscous products.

End-to-end vial filling lines for flexible Annex 1 compliant production

ALF_with_Telstar_FD_2

Formulation and pure media for product safety

Prepare liquid formulations and WFI to protect product quality and feed your vial filling line reliably.

Vial pretreatment

Clean, sterilize and depyrogenate vials so they enter the filling machine particle-free and ready for high-speed processing.

Filling and closing for flexible vial batches

Fill and close vials in an Annex 1 compliant filling machine with changeovers that support many formats while limiting interventions.

Freeze drying integrated into your vial line

Transfer filled vials to freeze-dryers with automated loading to cut handling risk and support stable lyophilization.

Isolator technology that limits interventions

Separate operators from the aseptic area with isolators or RABS designed to help you meet applicable regulations.

Inspection that secures batch release

Use inline and end-of-line inspection to detect particles, cosmetic defects and leaks early so you protect every batch.

Sterilization that supports aseptic safety

Apply dry heat sterilization for components so your aseptic area receives sterilized equipment.
ALF_with_Telstar_FD_2

Formulation and pure media for product safety

Prepare liquid formulations and WFI to protect product quality and feed your vial filling line reliably.
ALF_with_Telstar_FD_2

Vial pretreatment

Clean, sterilize and depyrogenate vials so they enter the filling machine particle-free and ready for high-speed processing.
ALF_with_Telstar_FD_2

Filling and closing for flexible vial batches

Fill and close vials in an Annex 1 compliant filling machine with changeovers that support many formats while limiting interventions.
ALF_with_Telstar_FD_2

Freeze drying integrated into your vial line

Transfer filled vials to freeze-dryers with automated loading to cut handling risk and support stable lyophilization.
ALF_with_Telstar_FD_2

Isolator technology that limits interventions

Separate operators from the aseptic area with isolators or RABS designed to help you meet applicable regulations.
ALF_with_Telstar_FD_2

Inspection that secures batch release

Use inline and end-of-line inspection to detect particles, cosmetic defects and leaks early so you protect every batch.
ALF_with_Telstar_FD_2

Sterilization that supports aseptic safety

Apply dry heat sterilization for components so your aseptic area receives sterilized equipment.

Explore the complete line

Formulation & pure media
Vial pretreatment
Filling & closing
Freeze drying
Isolator
Inspection
Sterilization

Compare our vial filling machines

Overall 2 Solutions
Output performance
Format range
Special features
Changeover
Filling systems
Container types
Barrier technologies and line integration
Benefits
ALF 5000 Vial Filling Machine
ALF 5000
Output performance
600 c/min, 100 % IPC vials
Format range
Vials 0.2 to 100 milliliters, ampoules 1 to 30 milliliters
Special features
High-speed combi, gentle carry
Changeover
Fast tool-free changeover
Filling systems
Up to 12 heads, supports all filling systems
Container types
Vials, molded glass, ampoules
Barrier technologies and line integration
RABS or isolator, lyo option
Benefits

Best if you want:

  • Safe flexible high-speed combi line for ampoules and vials
  • 100 % IPC and modular platform for high-potent or complex aseptic products
Specsheet
FLC3000 Vial Filling Machine
FLC 3000
Output performance
600 c/min, statistical IPC
Format range
Vials 0.2 to 500 milliliters
Special features
Compact, gentle vial transport
Changeover
Few parts, modular layout
Filling systems
Up to 12 heads, supports all filling systems
Container types
Vials, molded glass
Barrier technologies and line integration
RABS or isolator integration
Benefits

Best if you want:

  • Wide range, compact vial line for up to 500 milliliters
  • Compact medium to high output line for flexible layouts
Specsheet

Vial filling machines that combine speed, flexibility and Annex 1 compliance

_1220751 _1_ _1_

Up to 600 vials/min without losing flexibility

One flexible platform for 2–500 ml vials, from early clinical batches to high output commercial.
Freeze-dryer

One vial line from isolator to freeze dryer

Cut interfaces and manual transfers with one integrated line from vial filling to inspection.
R6_09669

100 % inspection concepts integrated in your vial line

Detect particles and leaks earlier with inline inspection, CCIT and empty-vial checks.
Technologies_Isolator_technology_Microbiological-1
Case Study

IDT Biologika boosts high speed vial capacity with Syntegon

IDT Biologika needed a fast, flexible vial line. Syntegon enables the production of 80-100 million 2R vials per year with 100 % IPC.

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Innovative Technologies. We enable market leadership.
syntegon-alcami-partnership-1
Case Study

Alcami doubles small batch vial capacity with turnkey line

Alcami required a flexible Annex 1 compliant line for 2-50 ml vials. Syntegon's ARF isolator line more than doubled daily output at the Charleston site.

value-icon-innovative-technologies
Innovative Technologies. We enable market leadership.
aj-vaccines-worker
Case Study

AJ Vaccines upgrades vial line for Annex 1 readiness

AJ Vaccines modernized an existing vial line with Syntegon RABS and barrier upgrades designed to help meet Annex 1 expectations while keeping capacity available.

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Innovative Technologies. We enable market leadership.
aspen-technology
Case Study

Aspen Pharmacare secures vaccine vial flexibility and scale

Aspen Pharmacare partnered with Syntegon on a flexible vial filling line that increases sterile vaccine capacity and supports multiple vial formats for future launches.

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Innovative Technologies. We enable market leadership.

Your strategic lifecycle partner for vial filling

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 and data solutions help you adapt to new demands, improve OEE, and keep your lines future-proof across changing requirements.

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Vial filling knowledge hub

Vial filling portfolio brochure for line concepts
Vial filling portfolio brochure for line concepts

See Syntegon vial filling machines, formats and outputs from formulation to inspection in one overview for your next line project.

Trend report on flexibility in vial line design
Trend report on flexibility in vial line design

Learn how to increase vial line flexibility, cut changeover and cleaning losses, and prepare for Annex 1 compliant production.

IDT Biologika high speed vial filling line case study
IDT Biologika high speed vial filling line case study

See how IDT Biologika scaled production to 80 to 100 million 2R vials per year with a high speed line, isolator and 100 % IPC.

Alcami small batch flexible vial filling line case study
Alcami small batch flexible vial filling line case study

Learn how Alcami doubled daily small batch vial capacity with a turnkey isolator line that handles 2 to 50 ml formats and lyophilization.

Aspen Pharmacare vaccine vial line case study
Aspen Pharmacare vaccine vial line case study

See how Aspen Pharmacare expanded sterile vaccine vial capacity with a Syntegon vial filling line designed for multiple formats ensuring high quality.

 AJ Vaccines Case Study
AJ Vaccines Case Study

Learn how AJ Vaccines future-proofed its line with a RABS-update from Syntegon.

Frequently asked questions

Syntegon vial filling machines and vial filling lines typically cover vial volumes from 2 to 500 ml. You can run small clinical batches and large commercial batches on the same aseptic vial filling platform, with format parts and transport systems designed for gentle handling. 

Yes. Syntegon designs complete vial filling lines from formulation and pretreatment through sterilization, filling and closing, freeze drying and inspection. Fillers, vial filling isolators or RABS, freeze dryers and inspection systems use standardized interfaces and one automation philosophy.

This helps reduce risky interfaces and is designed to help you meet Annex 1 focused contamination control needs. 

The pharmaceutical vial filling machines are ready for isolator or RABS integration and feature hygienic design, CIP/SIP capability and options for integrated PUPSIT filter test racks. 100% in process control and inline inspection concepts help monitor each vial and support Annex 1 focused contamination control and documentation.

Designs aim to keep operator intervention low so you can combine sterility assurance with flexible operation. 

In many cases, yes. Syntegon focuses on modular vial filling equipment and standardized interfaces, so you can add barrier systems, Telstar freeze dryers or new filling technologies later without rebuilding the entire line.

Retrofittable PUPSIT racks, single use fluid paths and digital upgrades can also increase flexibility and reduce downtime. Concrete upgrade options depend on line age and configuration. 

Syntegon aseptic vial filling equipment supports multiple systems, including rotary valve piston pumps, time pressure filling, peristaltic pumps, mass flow and rolling diaphragm pumps.

You can combine stainless steel multi use paths with single use assemblies where they add value. This helps you process liquid, lyophilized, oily and highly viscous products on one flexible vial filling platform.

Interested in vial filling machines?

Interested in vial filling machines?

Talk to a Syntegon expert to learn more about vial filling machines.

Learn more

News

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PDA James P. Agalloco Award for Markus Heinz

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