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A large SKAN integrated process isolator for pharmaceutical production, featuring multiple workstations, a conveyor system, and a vertical stainless steel tank on top.
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Isolators

Customized process isolator

Built around your process

Application type
Aseptic(-toxic)
Customization level
Customized
Customized process isolator at a glance

Precisely tailored to your processes, products, and requirements

  • Validated sterility

    Reliable aseptic conditions ensured by a robust decontamination system, HEPA filtration, and controlled airflow

  • Reliable decontamination

    > 6-log decontamination even on complex surfaces using proven SKAN H₂O₂ decontamination technology

  • Flexible process integration

    Integration of process equipment such as scales, mixing vessels, dosing pumps, or single-use systems

  • Custom design

    Individually adapted to facility layout, process steps, and production requirements

  • Secure material transfer

    Validated transfer solutions, including RTPs and airlocks, for maximum flexibility and process integrity

  • Energy-efficient air handling

    Optimized airflow and catalytic H₂O₂ decomposition reduce energy consumption and simplify facility design

  • Suitable for toxic substances

    Containment concepts up to OEB 6 with safe-change filters protect operators and the environment

  • Digital process control

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

Application

Safest aseptic processes at Grade A

  • For (bio-)pharmaceutical and API manufacturers

    SKAN process isolators are ideal for companies that need to tailor aseptic production steps to specific products, processes, and facility layouts. They are particularly suited to pharmaceutical and API processes, which are typically highly customized and process-driven.

  • For powder handling and active ingredient handling

    Across all stages of active substance processing, including formulation, weighing, mixing, compounding, transfer, and packaging, process isolators protect sensitive products from microbial contamination while ensuring safe working conditions for operators handling potent or toxic substances.

  • image desription

    For diverse aseptic processes

    Process isolators also enable a wide range of supporting aseptic operations, including sampling, sterile connections, material and component transfers, and other open product handling steps within a controlled environment.

A customized process isolator specifically designed for powder handling, featuring a large stainless steel vessel and sensors for precision manufacturing.
Automation

Integration of advanced robotic systems

Robotic systems can be directly integrated into the isolator to automate precise and reproducible process steps. They reduce manual interventions in critical areas and enhance process stability. Through close collaboration with technology partners, SKAN ensures that each robotic integration is optimally tailored to the specific process and facility configuration.

Internal view of an aseptic isolator featuring a robotic arm and specialized machinery for automated pharmaceutical powder handling in a sterile environment - by SKAN.
Process

Safe and integrated process workflows within the isolator

  • 1

    Material introduction

    Primary containers, consumables, and tools are introduced via a rapid decontamination airlock, rapid transfer ports (RTPs), or placed in the isolator prior to the H₂O₂ decontamination cycle.

  • 2

    Material handling and transfer to the process area

    Following introduction, materials and products are transferred to the designated process area. Depending on the application, this may involve a dosing unit or an integrated process workstation within the isolator.

  • 3

    Powder handling and active substance dosing

    Active substances are weighed, dosed, or transferred into process containers under controlled isolator conditions. Closed transfer systems and integrated high-precision scales ensure safe and reproducible operations.

  • 4

    Aseptic formulation or compounding

    Active ingredients are combined with buffers or solvents under aseptic conditions. Equipment such as mixing vessels, dosing pumps, or single-use assemblies can be directly integrated into the working chamber.

  • 5

    Aseptic product handling

    Critical operations, including sampling, sterile connections, and preparation for transfer, are performed within the controlled isolator environment. Monitoring systems continuously track key parameters such as airflow, particle concentration, and pressure differentials.

  • 6

    Safe transfer to downstream processes

    Formulated products or intermediates are transferred via validated interfaces to downstream operations, including sterile filtration, bulk storage, or aseptic filling.

  • case-story-biom
    Case story

    Maximum safety in formulation

    How SKAN designed an isolated process environment for Bio-Manguinhos – ensuring high purity, reliable product protection, and stable conditions for sensitive pharmaceutical formulation processes.

    Learn more
Regulatory requirements

Regulatory assurance for aseptic process steps

  • Global compliance standards

    SKAN designs and validates isolators in accordance with current EU-GMP guidelines, including Annex 1. Comprehensive documentation supports qualification and regulatory approvals.

  • State-of-the-art automation

    Automation systems meet requirements such as 21 CFR Part 11 and GAMP guidelines. SCADA integration and audit trails ensure data integrity.

  • Comprehensive sterility assurance strategy

    Decontamination, transfer solutions, glove management, and monitoring strategies together form a fully validated end-to-end concept for aseptic processes.

Exterior view of a SKAN stainless steel pharmaceutical isolator featuring multiple glass viewing panels and integrated white protective sleeves with blue seals for sterile material handling.
Product highlights

Key technologies for process isolators

  • These systems feature a multi-chamber layout. The interior view shows a central processing zone flanked by multiple glove ports (black) for operator access, while the exterior view highlights a clean, flush-mounted stainless steel facade with integrated status lighting and control panels.

    Flexible integration concepts

    Process isolators can be customized with process equipment, transfer solutions, and automation systems to enable complete production workflows under aseptic conditions.

  • A close-up of a stainless steel "skanfog" decontamination nozzle integrated into a sterile enclosure. The circular metal component is flush-mounted against a smooth, industrial surface, designed for H2O2 fogging in cleanroom environments.

    From concept study to fully realized facility

    SKAN provides support not only in designing the isolator itself but also early in the project with concept and airflow studies, cleaning strategies, and risk analyses. This ensures a solution that is technically and regulatorily aligned with the specific process.

  • A high-angle interior view of a customized aseptic process isolator.

    Advanced air handling

    HEPA filtration, unidirectional airflow, catalytic H₂O₂ decomposition, and flexible pressure zone concepts ensure stable aseptic conditions and, optionally, containment for toxic products.

Picture of a customized process isolator from SKAN.
Picture of a customized process isolator from SKAN.

Technical specifications

  • Working chamber

    EU-GMP Grade A (ISO 5)

  • Decontamination

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

  • HEPA filtration

    H14 filters covering the entire process area

  • Airflow

    Unidirectional airflow with CFD-optimized flow design

  • Exhaust air

    Direct to room using SKAN nanox catalyst for rapid decomposition of hydrogen peroxide after decontamination

  • Pressure zone concept

    Flexible pressure cascades; overpressure operation for aseptic processes and underpressure operation for highly potent substances

  • Containment

    Optional up to OEB 6 to protect operators, product, and environment

  • User interface

    HMI with Beckhoff Industrial PC and multitouch monitor

  • Control

    PLC-based; Siemens or Allen Bradley

  • SCADA solutions

    WinCC, Zenon, FactoryTalk

  • Regulatory compliance

    21 CFR Part 11 compliant

FAQs

  • Typical applications include weighing and dosing of active substances, aseptic formulation, sampling, and material transfers in biopharmaceutical production processes.

  • Depending on the process, scales, mixing vessels, dosing pumps, or other process equipment can be integrated.

  • Sterility is maintained through H₂O₂ decontamination, HEPA filtration, controlled airflow, and closed transfer systems.

  • Yes. SKAN process isolators are individually configured and can be designed for research, clinical development, or commercial production.

  • High availability is supported by robust equipment design, preventive maintenance, spare part management, and remote support. Service concepts and digital monitoring solutions enable early detection of potential issues and help maintain stable production.

  • Yes. SKAN provides support in early project phases with feasibility assessments, concept studies, mock-ups, airflow analyses, cleaning strategies, and risk assessments to define the most suitable isolator solution for the process.

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