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PSI-L Isolator
Isolators

PSI-L

The Swiss Army Knife among isolators

Application type
Aseptic(-toxic)
Customization level
Modular configuration
PSI-L at a glance

Modular isolator platform for aseptic and toxic processes

  • Maximum process reliability

    Reproducible Grade A conditions for aseptic and aseptic–toxic processes

  • Highest product and operator protection

    Closed or open isolator technology for sensitive and highly potent applications

  • Wide range of applications

    Suitable for formulation, compounding, sterility testing, handling of toxic substances, and ATMP processes

  • High flexibility

    Adaptable to different processes, media, and levels of automation

  • Interchangeable process units

    Rapid module changeover via the standardized L-flange

  • Short decontamination cycles

    Integrated skanfog system for efficient H₂O₂ decontamination

  • Compact platform design

    Small footprint with high process integration

  • Fast implementation

    Standardization and pre-production reduce delivery and project timelines

Application

Flexible platform for demanding pharmaceutical processes

  • For pharmaceutical manufacturers

    Suitable for aseptic upstream and downstream processes, for example in formulation, compounding, sterility testing, or handling of highly potent substances.

  • For biotech and ATMP applications

    Suitable for process steps in handling sensitive products such as cell and gene therapies, including formulation, sample handling, preparation, and product-close transfers.

  • For C(D)MOs

    Ideal for companies with changing product requirements, customer-specific processes, and modular setups in development, clinical phases, and small-scale production.

Process

Integrated aseptic end-to-end process within a modular isolator platform

  • 1

    H₂O₂ decontamination

    Before process start, automated decontamination is performed using the integrated skanfog system. The validated decontamination achieves a >6-log reduction, providing the basis for reproducible aseptic conditions within the isolator.

  • 2

    Material transfer and preparation

    Materials, raw materials, and process components are safely introduced into the isolator via H₂O₂ airlocks, RTP ports, or AT port for liquids, and prepared for the respective process.

  • 3

    Core aseptic processes

    Open or closed aseptic process steps are carried out within the isolator, such as formulation, compounding, sieving, sterility testing, or ATMP-specific applications. Depending on requirements, operations can be manual, semi-automated, or supported by integrated robotics.

  • 4

    Toxic containment

    Closed systems with safe-change filters, wash-in-place (WIP) spray guns, and drain systems enable safe handling of highly potent substances and protect operators as well as the environment.

  • 5

    Product removal and further processing

    Finished intermediates, samples, or final products are discharged under controlled conditions and can subsequently undergo further steps such as inspection, packaging, or storage.

Product highlights

Maximum flexibility for your aseptic processes

  • Pharmaceutical Safety Isolator (PSI-L)

    Rapid process change without modifying the isolator

    The standardized L-flange allows entire process units to be exchanged without altering the isolator platform itself. This makes it easy to integrate new applications, equipment, or partner solutions quickly.

  • PSI-L Operator

    One platform for diverse aseptic applications

    PSI-L is not limited to a single process step but covers a wide range of applications. Each chamber functions as an independent isolator, with its own air handling, monitoring, and reporting.

  • PSI-L Isolator L-Flange Modular

    Standardized platform with short project timelines

    The standardized platform concept with pre-configured modules reduces capital investment, simplifies project execution, and shortens time to operation.

Regulatory requirements

Validation-ready, audit-compliant, and designed for global standards

  • EU-GMP Annex 1 and FDA compliance

    Designed to meet the highest regulatory requirements, including EU-GMP Annex 1. Aseptic processes and decontamination are reproducible, fully validated, and documented for audits.

  • Data integrity and qualification

    Qualifiable according to GAMP 5. Electronic records and user management support 21 CFR Part 11, with batch and process data stored in a secure, audit-traceable manner.

  • Integrated monitoring

    Sensors for H₂O₂, pressure, airflow, temperature, and other environmental parameters, along with integrated viable and non-viable monitoring solutions, ensure compliance with regulatory requirements for process control, documentation, as well as product and operator protection.

PSI-L Isolator Operator Opened

Technical specifications

  • Standard working chamber

    2000 × 1417 × 3000 mm (W × D × H)

  • H₂O₂ transfer airlock

    1000 × 1417 × 3000 mm (W × D × H)

  • Working chamber weight

    Approx. 1950 kg

  • Airlock weight

    Approx. 800 kg

  • Room height

    Minimum 3 m

  • Working chamber

    EU-GMP Grade A (ISO 5)

  • Decontamination

    >6-log decontamination via skanfog H₂O₂ micro-nebulization

  • HEPA filtration

    Double HEPA filtration for supply and exhaust air

  • Airflow

    Unidirectional airflow

  • Operating modes

    Over- or underpressure operation possible with pressure cascades between modules

  • Containment

    Integrated safe-change filters for potentially contaminated return air

  • Washdown option

    Spray nozzles with WFI connection and drains for aseptic–toxic applications

  • Exhaust air

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

  • Material transfer

    H₂O₂ airlock with automatic leak test and independent airflow

  • RTP

    Rapid Transfer Port, integrable into the side wall or L-flange

  • AT-Port

    Aseptic liquid transfer between room and isolator

  • Viable monitoring

    Integration of active air samplers at critical locations

  • Particle monitoring

    Integrated particle counter with isokinetic probe

  • Pressure and filter monitoring

    Differential pressure monitoring to cleanroom and for individual HEPA filters

  • H₂O₂ and occupational safety

    H₂O₂ sensors and TLV monitoring

  • Environmental sensors

    Sensors for airflow, temperature, and relative humidity

FAQs

  • The platform can be configured for manual, semi-automated, or fully automated processes. Depending on the application, robotic systems can also be integrated.

  • Yes. The standardized L-flange is specifically designed for quick integration of process modules and partner equipment. In addition to standardized solutions, custom process units can also be implemented.

  • Yes. The platform is designed for small volumes, flexible processes, and ATMP-relevant applications, and can be combined with specialized modules such as incubators or centrifuges.

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