Customized filling line isolator

Seamless integration for reliable filling processes

Application type: Aseptic(-toxic)
Customization level: Customized

Customized filling line isolator at a glance

Custom-built to meet your requirements

Validated sterility

Reliable aseptic conditions due to a robust decontamination system, HEPA filtration, and unidirectional, controlled air flow
Reliable decontamination

>6-log decontamination even on complex surfaces using SKAN’s validated H₂O₂ decontamination technology
Seamless line integration

Optimal integration of filling lines, lyophilizers, and other process modules into a coordinated end-to-end system
Tailored design

Individually adapted to room layout, line configuration, batch sizes, and production requirements
Safe material transfer

Validated transfer solutions such as H₂O₂ airlocks, Rapid Transfer Ports (RTPs) or ebeam ensure maximum sterility and process integrity
Energy-efficient air handling

Reduced energy consumption and simplified facility design through optimized airflow and catalytic H₂O₂ breakdown
Suitable for toxic substances

Containment concepts up to OEB 6 (validated) with safe-change filters protect operators and the environment
Digital process control

SCADA systems with audit trail, Active Directory integration, and GMP-compliant data capture

Application

Maximum safety in aseptic(-toxic) filling

For aseptic filling

Customized isolators ensure aseptic filling of RTU containers such as vials, syringes, and cartridges, as well as bulk vials and cartridges for medium to large batch sizes.
For aseptic-toxic filling

Isolators for highly potent compounds provide containment up to OEB 6. Safe-change filter systems, defined pressure cascades, and cleaning systems protect operators, product, and the environment.
For a seamless lyophilizer integration

Isolator, filling line, and lyophilizer are integrated into a coordinated, end-to-end line concept.

Close-up of glass vials moving through an automated pharmaceutical filling line with stainless steel machinery.

Fill Finish

Integration with leading filling line manufacturers

SKAN isolators are designed for integration with leading filling line manufacturers. Extensive project experience, established mechanical and automation interfaces, and coordinated project management enable an efficient implementation and seamless integration into complete fill-finish lines.

Technician in a full blue cleanroom suit working at a stainless steel isolator line in a sterile pharmaceutical production facility.

Process

Maximum safety in fill-finish processes through high-end technology

1

Sterilization and transfer of process-critical materials

Closures and other components are pre-sterilized, for example, by autoclaving or H₂O₂ decontamination (see material transfer isolator mat). The transfer into the system is performed via Rapid Transfer Ports (RTPs) or liquid transfer systems.
2

Aseptic transfer of containers

Vials, syringes, or tubs are sterilized inline, for example by depyrogenation or ebeam surface sterilization. This ensures a fully closed aseptic process chain.
3

Aseptic or aseptic-toxic filling in the isolator

All process steps take place under validated EU-GMP Grade A (ISO 5) conditions. Unidirectional airflow and controlled air change rates maintain a consistently sterile production environment.
4

Monitoring and automation

Monitoring systems continuously track critical parameters such as airflow, particle levels, and pressure differentials. Automation systems document all process data GMP-compliant, enabling full traceability.
5

Sterile transfer to downstream processes

Filled products are safely transferred via validated interfaces to downstream processes such as lyophilization, capping, or inspection, remaining protected throughout the entire process.

Product highlights

Key technologies for filling line isolators

Reliable decontamination technology

SKAN offers a range of technologies for efficient H₂O₂ decontamination. With over 20 years of experience, even complex line layouts can be decontaminated safely and reproducibly.
Intelligent air handling

HEPA filtration, unidirectional airflow, catalytic H₂O₂ breakdown, and flexible pressure zone concepts ensure stable aseptic conditions and optional containment for toxic products.
Comprehensive documentation

Every filling line from SKAN comes with complete, structured GDP documentation according to international standards, supporting qualification, validation, and regulatory approvals.

Regulatory requirements

Regulatory excellence for filling processes

Global compliance standards

SKAN develops and validates isolators in accordance with EU-GMP guidelines, such as Annex 1. Comprehensive documentation supports qualification and regulatory approvals.
State-of-the-art automation

Automation systems meet the requirements of CFR 21 Part 11 and GAMP 5 guidelines. SCADA integration and audit trails provide full data integrity.
Comprehensive sterility assurance strategy

Transfer solutions, glove management, monitoring strategies, and surface sterilization via ebeam complement the isolator technology to create a fully validated end-to-end process.

Technical specifications

Working chamber

EU-GMP Grade A (ISO 5)
Decontamination

H₂O₂ decontamination, e.g., skanfog micro-nebulization or SIS vaporization
HEPA filters

H14 HEPA filters across the entire process area
Airflow

Unidirectional airflow with CFD-optimized flow design
Exhaust

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

Flexible pressure cascades; positive pressure for aseptic processes and negative pressure for highly potent compounds

Bausch + Ströbel

Our partner Bausch + Ströbel offers highly automated filling lines, from clinical trial scales to commercial high-performance lines
groninger

groninger filling lines are designed for flexible production concepts and can handle vials, syringes, and cartridges across a wide range of batch sizes

User interface

Intuitive HMI with remote access and data interfaces
Control

PLC-based; Siemens or Rockwell
SCADA solutions

WinCC, Zenon, FactoryTalk
Regulatory compliance

21 CFR Part 11-compliant

FAQs

Sterility is guaranteed through a validated overall concept combining H₂O₂ decontamination, HEPA filtration, and controlled airflow. Closed transfer systems and validated desinfection steps during material transfer into the isolator prevent contamination. Continuous monitoring, along with regular microbiological (re)qualification, ensures compliance with regulatory requirements.
Yes. SKAN isolators can be integrated into both new and existing production lines. Standardized interfaces allow connection to filling machines and other process equipment, such as lyophilizers. On the automation level, vertical integration enables inclusion in overarching production and management systems.
SKAN isolators for filling lines are modular and can be adapted to different product formats, batch sizes, and process requirements. Flexible line configurations and short changeover times allow efficient processing of multiple products, with capacities of up to 72000 units per hour.
Isolators for highly potent compounds are designed with appropriate containment concepts, such as negative pressure operation or defined pressure cascades. Additionally, safe-change filter systems are also used. Containment effectiveness can be additionally verified through tests, for example according to the SMEPAC standard.
In addition to a robust system design, preventive maintenance, spare parts management, and remote support contribute to high availability. Service concepts and digital monitoring solutions allow early detection of potential issues and support stable production operations.