flexfill

The flexible solution for RTU filling

Application type: Aseptic
Customization level: Modular configuration

Primary packaging

RTU
Units per hour

Up to 24,000
Filling volume

0.1-50 ml
Partner

groninger

flexfill at a glance

flexfill + ebeam: The fastest route to validated aseptic RTU filling

Safe transfer with ebeam

Dry RTU transfer without H₂O₂, 12-log surface sterilization
Rapid start-up

Preconfigured modules allow delivery times starting from 8 months
Documentation from day one

Design and qualification documentation available immediately
Annex 1-compliant design

Meets all key regulatory requirements with validated in-process controls
Various safety features

E.g. infrared-assisted tub opening and single-disc capping
Maximum flexibility

3-in-1 system for RTU syringes, cartridges, and vials
Tool-free format change

Reduced changeover times and increased line availability
Partner technology from groninger + SKAN

Standardized interfaces between isolator and filling line

Application

Maximum flexibility for medium batch sizes

For pharmaceutical manufacturers

Pharmaceutical companies that process RTU containers, such as syringes, vials, or cartridges under aseptic conditions, receive a flexible filling line in accordance with the latest regulatory standards.
For C(D)MOs

Contract manufacturers benefit from a line that can be quickly commissioned and flexibly adapted to changing customer requirements.
For the filling of demanding products

flexfill is suitable for products with special requirements. Options such as vacuum filling, vacuum stoppering, and gas purging enable the gentle processing of sensitive products and cartridges.

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

Efficient process with automated in-process controls

1

Transfer and surface sterilization with ebeam

The RTU tub surface is treated with accelerated electrons (beta radiation, > 25 kGy). This achieves a dry, residue-free, fully validatable 12-log surface sterilization.
2

Alternative transfer method: No-Touch Transfer

As an alternative to ebeam, a No-Touch Transfer (NTT) can be integrated.
3

Automated tub opening

After transfer, the adhesive beneath the tub lid is activated by infrared radiation. Lid and liner are removed particle-free via a vacuum roller system and disposed of outside the aseptic area. The first-air principle is strictly maintained.
4

Aseptic filling

Dosing is performed via a five-head peristaltic or rotary piston pump (or combination). For high-viscosity or oxygen-sensitive products, vacuum filling and gas purging (e.g., nitrogen) options are available. In-process controls for statistical monitoring of dosing accuracy are integrated.
5

Sealing

Stoppers and caps are sorted via format-flexible feed paths, no special sorting trays required. Optional vacuum-assisted stoppering and gas purging during sealing are possible. A camera system and sensors monitor stopper presence and position.
6

Denesting and capping (optional)

For RTU vials, automatic denesting is performed. Subsequently, a low-particle capping process is carried out using groninger’s patented single-disc technology. Capping quality can be camera-monitored.

Product highlights

Modular approach for your individual requirements

Validated RTU transfer with ebeam

flexfill combines a preconfigured filling process with the ebeam system for dry, chemical-free surface decontamination – fast, validated, seamlessly integrated into the isolator.
Standardized yet individually configurable

Around 80% of the system modules are predefined. By selecting appropriate module packages, the line can be tailored to specific production requirements without long development times.
Maximum flexibility for formats and products

flexfill supports RTU syringes, cartridges, and vials in various nest sizes. With gas purging and vacuum options, the line is also suitable for demanding products.

flexfill + ebeam: The fastest route to validated aseptic RTU filling.

Technical specifications

Layout 1: Syringe processing

Transfer system (ebeam or NTT), infeed module for tub opening, filling and sealing module
Layout 2: Syringe, cartridge, and vial processing

Transfer system (ebeam or NTT), infeed module for tub opening, filling and sealing module as well as crimping module

Performance

Up to 24000 units/hour (format-dependent)
Formats

RTU syringes, vials, cartridges in nest/tub (flexible tub size)
Filling volume

0,1 – 50 ml
Closures

Stoppers, caps
Tub throughput ebeam

Up to 6 tubs/minute
ebeam formats

Compatible with 2″, 3″, 4″, 5″ RTU tubs with minimal adjustments

Working chamber

EU GMP Grade A (ISO 5)
Decontamination

skanfog H₂O₂ micro-nebulization with short cycles (>6-log decontamination)
Filter

H14 filters over the entire process area
Airflow

Unidirectional first-air flow, 0,45 m/s over critical process area
Exhaust

Direct to room thanks to SKAN nanox catalyst for rapid H₂O₂ decomposition after decontamination (one-pass degradation of H₂O₂ <0,1 ppm)

Filling system

Five-head peristaltic or rotary piston pumps, combined
In-Process-Control (IPC)

Statistical monitoring, e.g., dosing, stopper/cap control
Vacuum filling and stoppering / gas purging

Optional for oxygen-sensitive or high-viscosity products
Format change system

Tool-free changeover, reduced number of format parts
Stopper/cap feeding

Format-independent via feed paths instead of sorting trays
Denesting (optional)

Automatic vial separation
Capping (optional)

Camera-based capping control, low-particle process via single-disc capping

Automation system

PLC-based (Siemens or Rockwell)
User interface

SCADA HMI (local or remote), GMP- and CFR 21 Part 11-compliant
Data management

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

SKAN sphere health: component monitoring, maintenance log
Communication

Open standards: OPC-UA, SQL
Alarms and user management

Integrated alarm and user management

FAQs

When speed, validation, and regulatory clarity are critical: Pre-defined modules make flexfill faster to deploy than fully custom solutions. At the same time, there is sufficient flexibility for project-specific adaptations without long development cycles or unclear interfaces.
flexfill minimizes risks through standardized, validated components, clearly defined interfaces, and immediately available documentation. This simplifies project planning, accelerates regulatory approvals, and shortens time-to-production, especially critical for innovative product candidates with tight timelines.
It refers to an RTU transfer process that requires no H₂O₂ conditioning, is fully closed, and achieves validated 12-log surface sterilization. For operators, this means less complexity, faster transfers, no chemical residues, and full Annex 1 compliance.
Format changes are tool-free. Intelligent format design, modular line architecture, and standardized automation make flexfill well suited for changing products and packaging – ideal for CDMOs or multi-product lines.
No, the line is designed exclusively for aseptic production.
24/7 hotline, remote support, requalification, global spare parts supply, and training ensure line availability.