Skip to content
Integrated aseptic filling line “integra” by SKAN and groninger with isolator and glove ports.
Back
Fill finish solutions

integra

The best integrated vial filling line for pharma and biotech

Application type
Aseptic(-toxic)
Customization level
Modular configuration

  • Primary packaging

    Vials (Bulk)

  • Units per hour

    Up to 24,000

  • Filling volume

    1-100 ml

  • Partner

    groninger

integra at a glance

Integrated groninger + SKAN isolator line for efficient vial filling

  • Batch flexibility

    Suitable for different vial sizes, fill volumes, and production scales

  • Flexibility through lyophilization integration

    Standardized interface to lyophilization partners

  • High efficiency

    Fast changeover times and an efficient filling system minimize product loss

  • Annex 1-compliant design

    Regulatory compliance through validated transfers, optimized First Air design, and 100% in-process controls

  • Reduced contamination risk

    Minimized number of glove ports through compact machine design

  • All-in-one solution

    Holistic execution with tightly aligned project management

  • Seamlessly integrated filling solution from groninger

    40 years of project experience as the foundation for a joint, standardized line concept

  • Fast commissioning

    Standardized, configurable modules enable short project timelines

Application

Flexible vial filling for large batch sizes

  • For pharmaceutical production

    Suitable for filling parenteral small-volume drugs such as mAbs, vaccines, or biologics in medium to large batch sizes. Also suitable for handling toxic products.

  • For veterinary pharmaceutical production

    For sterile filling of veterinary drugs in vials – suitable for vaccines, antiparasitics, and biologics with high requirements for process safety.

  • image desription

    For C(D)MOs

    Ideal for contract manufacturers with high demands on flexibility and regulatory compliance.

Close-up of filling needles dosing liquid into vials within isolator system.
Fill Finish

Partnership with groninger

The best of two worlds: SKAN and groninger combine their strengths to set new standards in aseptic filling. Discover how isolator technology, filling expertise and a shared vision come together to create an integrated end-to-end system.

Learn more
Process

Fully integrated vial filling process – from cleaning to tray loading

  • 1

    Washing and drying

    Vials are unpacked, fed, and efficiently cleaned and dried inside and out – optimized WFI usage and designed for 3-log particle reduction.

  • 2

    Sterilization and depyrogenation

    Gentle heating in the sterilization tunnel with 3- or 6-log efficacy and high-end filtration – prevents overkill and ensures process reliability.

  • 3

    Filling and sealing

    Precise filling of all standard vials, including stoppering for maximum product yield. Vacuum-free stoppering and reject stations enable handling of potent/toxic substances.

  • 4

    Optional lyophilization

    Compact interface for integrating a lyophilizer – seamless transition between liquid and lyophilized production.

  • 5

    Capping

    Low-particle sealing using patented groninger single-disc technology.

  • 6

    Discharge

    Tray loading of vials.

  • case-story-merz
    Case Story

    Scaling production at speed

    How Merz Pharma, SKAN and partners rapidly implemented a high-performance filling line – tripling production capacity within a short timeframe through an integrated, scalable and efficient solution.

    Learn more
  • Case_Story_Civica

    For reliable access to medicines in the US

    How Civica, SKAN and groninger are building a flexible manufacturing setup in the US – designed to reduce drug shortages and ensure a reliable, affordable supply of essential medicines for patients.

    Learn more
Product highlights

Technology partnership for maximum safety and efficiency

  • Operator monitoring integra filling line via touchscreen in cleanroom isolator environment.

    Ergonomic single-sided design

    Compact layout allows operation and cleaning from one side – glove ports reduced by ~50%, required filters by ~30%. This reduces contamination risks in accordance with Annex 1 and facilitates maintenance.

  • Clean integra isolator interior with glove ports for aseptic operations.

    Optimized filter handling

    Return air channels are protected with HEPA filters to enable safe filter changes and aseptic/toxic processing. Cartridges can be automatically locked – no complex bag-in/bag-out procedures required.

  • Closer view of integra isolator section with glove ports and integrated control unit.

    Standardized line concept with attractive delivery time

    High planning reliability is achieved through a largely standardized machine and line concept, reducing engineering, production, and commissioning times.

integra - Integrated groninger + SKAN isolator li.ne for efficient vial filling
integra - Integrated groninger + SKAN isolator li.ne for efficient vial filling

Technical specifications

  • Layout

    Compact line layout with modular design – ideal for existing production spaces.

  • Modules

    Vial infeed, washing machine, depyrogenation tunnel, fill and closing module, outfeed/tray loading

  • Optional modules

    Lyophilizer interface, capping module

  • Capacity

    Up to 24,000 units/hour

  • Processing range

    2R-100H vials

  • Fill volume

    0.2-100 ml

  • Working chamber

    EU-GMP grade A (ISO 5)

  • Decontamination

    6-log decontamination via skanfog H₂O₂ micro-nebulization with short cycles (<2 h to 1 ppm)

  • Filters

    Reliable airflow between two barrier HEPA filters

  • Filter change

    Automated, secure HEPA filter replacement

  • Airflow

    Unidirectional first-air flow at 0.45 m/s over critical process area

  • Exhaust

    Direct to room via SKAN nanox catalytic converter for rapid decomposition of H₂O₂ after decontamination (one-pass decomposition of H₂O₂ < 0.1 ppm)

  • Filling system

    Peristaltic, rotary piston pumps, combination filling, single-use systems

  • Product loss minimization

    Minimal product loss during commissioning, filling, and end-of-production

  • In-process controls (IPC)

    100% IPC for up to 400 units/min

  • Gassing

    Pre-, post-, and closure gassing with residual O₂ <1%

  • Format change system

    Adjustable transport rails for fast format changes with reduced component count

  • Stoppering

    Stopper addition function

  • Automation system

    PLC-based system; Siemens or Allen-Bradley

  • User interface

    HMI SCADA monitoring and control system, GMP-compliant and 21 CFR Part 11-capable

  • Communication

    OPC interface

  • Data management

    SKAN sphere connect: plug-and-play AVEVA PI integration, automatic reporting

  • Asset monitoring

    SKAN sphere health: component monitoring, maintenance log

FAQs

  • The platform is designed for liquid, parenteral products such as biologics, mAbs, or highly potent substances.

  • integra is designed for variable vial formats and fill volumes, suitable for clinical trials as well as commercial series.

  • Yes, the system is GMP-compliant and meets all relevant requirements of EU-GMP Annex 1.

  • The system is SCADA-capable and can be integrated with MES and LIMS systems. Batch data, audit trails, and process parameters can be automatically documented and integrated into digital production systems.

  • The pre-configured platform significantly shortens planning and commissioning times. Compared to fully custom solutions, integra is faster to deliver and ready for production.

  • 24/7 hotline, remote support, requalification, global spare parts supply, and training ensure the availability of the system.

Related products

Related services

Get in touch!

Whether you have a question about our products, need technical support or would like to find out more about our solutions.

Back to top