VarioSys

Keep it simple – keep it flexible

Application type: Aseptic(-toxic)
Customization level: Modular configuration

Primary packaging

RTU, Vials (Bulk)
Units per hour

Up to 4,500
Filling volume

0.5-100 ml
Partner

Bausch+Ströbel

VarioSys at a glance

Modularity for your filling processes

Maximum process reliability

Reproducible Grade A conditions within the isolator for aseptic and high-potency processes
Highest product and operator protection

Suitable for aseptic and toxic applications through isolator-based containment technology
High flexibility

Modular adaptation to different processes, container types, and production requirements
Plug-and-play integration

Fast installation and easy expansion through standardized modules
Lock-and-key principle

Tool-free exchange of machine modules for maximum adaptability
Scalable production

From clinical batches to commercial manufacturing within a single system
Space and time efficiency

Compact design and optimized processes reduce infrastructure and operational effort
Future-proof platform

Expandable with additional process steps such as lyophilization and automation

Application

Maximum flexibility for pharmaceutical filling

For pharmaceutical manufacturers

VarioSys is suitable for aseptic(-toxic) filling in early development phases, clinical applications, and small to medium commercial batches.
For C(D)MOs

Designed for flexible processing of changing products and formats, as it supports filling of RTU vials, prefilled syringes, and cartridges, as well as bulk vials.
For biotech companies

Also suitable for producing personalized therapies and small-batch manufacturing under aseptic conditions.
For research and development

VarioSys can be used for realistic process development and seamless scale-up on a single platform.

Fill Finish

Partnership with Bausch+Ströbel

More than just an interface: SKAN and Bausch + Ströbel combine long-standing partnership with coordinated technology. Discover how their shared expertise creates integrated aseptic solutions.

Learn more

Process

Modular filling process for RTU containers and bulk vials

1

Material transfer and decontamination

Materials and components are introduced into the isolator, via an airlock, and prepared for operation using H₂O₂ decontamination.
2

Introduction of packaging into the isolator

RTU containers are automatically de-bagged, opened, and de-nested. Bulk containers undergo upstream washing and sterilization processes.
3

Feeding and handling

Containers are transported in line with process requirements, separated, and precisely positioned. Robotic handling systems are available.
4

Filling

Dosing is carried out via integrated filling modules for liquid, powder, or highly viscous products. Continuous in-process control ensures product quality.
5

Container closure

Filled vials, syringes, or cartridges are closed, for example by stoppering, capping, or crimping.
6

Optional lyophilization

If required, vials are automatically transferred to the integrated lyophilization system from GEA, freeze-dried, and subsequently returned.
7

Discharge and further processing

Finished products are discharged under maintained aseptic conditions and can subsequently undergo further processing steps such as inspection.

Product highlights

Future-ready through interchangeable modules

RTU and bulk processing in one system

Processing of RTU and bulk containers within a single system, flexibly combinable without separate lines or system changeovers.
True modularity through interchangeable process modules

Modules are integrated based on the lock-and-key principle and can be quickly adapted to new products, formats, or processes.
Continuous process chain without system breaks

Handling, filling, closing, and optional lyophilization within a closed, isolator-based environment.

VarioSys - Maximum flexibility for pharmaceutical filling.

Technical specifications

Process unit (L-flange)

1.65 × 2.5 × 1.25 m (W × H × D)
Standard working chamber

2 × 3 × 1.5 m (W × H × D)
Large working chamber

3.25 × 3 × 1.5 m (W × H × D)
H₂O₂ transfer airlock

1 × 3 × 1.5 m (W × H × D)
Minimum suspended ceiling height

3 m

Performance

Up to approx. 4500 containers/hour (configuration-dependent)
Formats

RTU vials, syringes, and cartridges, as well as bulk vials
Filling volume

0.5 to 100 ml (depending on the filling system)
Products filled

Liquids, powders, and highly viscous products
Unstable containers

Processing possible with transport aids

Working chamber

EU-GMP Grade A (ISO 5)
Decontamination

> 6-log decontamination via skanfog H₂O₂ micro-nebulization
HEPA filters

H13/H14 across the entire process area
Airflow

Unidirectional airflow
Operating modes

Over- or underpressure operation possible with pressure cascades between modules
Abluft

Directly into the room thanks to SKAN nanox catalyst for rapid decomposition of hydrogen peroxide – alternatively via the technical floor to the outside

Filling systems

Peristaltic pumps, rotary piston pumps, and other dosing systems
In-Process Control (IPC)

Up to 100% monitoring of dosing and process parameters
Closure systems

Stoppers, crimp caps, screw caps

Integration

Fully integrated GEA lyophilizer
Loading and unloading

Automatic vial loading and unloading
Performance ranges

Available for both development and production scale

FAQs

The Pharmaceutical Isolator with L-flange (PSI-L) is a modular isolator system featuring a unique L-shaped flange specifically designed for VarioSys. This allows process equipment to be exchanged very quickly using the “lock-and-key” principle.
Format or process changes can be completed in under 30 minutes.
Yes. Closed airflow, HEPA filtration, and containment enable safe handling of toxic and highly potent substances (OEB-5/BSL-2).