SKAN Modular pure² Isolator – A Configurable Approach to Aseptic Cell & Gene Therapy Processing
The SKAN Modular pure² Laboratory Isolator is a new addition to SKAN’s isolator portfolio, developed to support flexible aseptic Cell & Gene Therapy workflows within a controlled GMP Grade A environment.
Cell and Gene Therapy manufacturing processes vary significantly between applications, often requiring different handling stages, equipment integration, and environmental control strategies. To support these requirements, containment systems must provide reliable aseptic protection while remaining adaptable to the structure of the process. The Modular pure² has been developed to offer a configurable ISO 5 environment.
Process-integrated system design.
The Modular Laboratory Isolator system is designed to integrate with the process workflow rather than constrain it within a fixed configuration. Individual chambers, transfer airlocks, incubators, and integrated equipment modules can be combined to create a single enclosed aseptic environment tailored to defined process steps.
This approach enables workflows to be structured in a way that reflects the sequence of operations, while maintaining a controlled environment throughout. As requirements evolve, modules can be added, repositioned, or reconfigured without requiring a complete system redesign, supporting longer-term adaptability in Cell & Gene manufacturing.
Controlled transfer and environmental continuity.
Material transfer between process stages is managed through a purpose-designed airlock system connecting multiple chambers within the isolator configuration. This allows movement between steps without breaching containment or compromising environmental conditions.
Maintaining a continuous aseptic boundary during transfer reduces reliance on external handling and supports more consistent execution of multi-step processes.
Where temperature-sensitive materials are involved, the system can be configured with integrated cooling plates within the main chamber work surface. This enables controlled thermal handling while again, maintaining full containment, helping to preserve product stability during critical processing steps.
The modular platform can also incorporate a fully integrated incubator, allowing incubation to take place within the same controlled environment. With direct access from inside the isolator, materials remain within the aseptic boundary throughout, removing the need for transfer between separate equipment.
Operation and system control.
Operational control is based on reproducible decontamination cycles using SKAN’s integrated hydrogen peroxide (H₂O₂) system, applied across the isolator platform.
The system supports configurable pressure regimes, enabling operation under either positive or negative pressure depending on process requirements. System monitoring and batch data capture are integrated into the control interface to provide traceability of key operational parameters.
A touchscreen interface provides direct access to system functions, supporting setup, operation, and cycle management within a single control environment. This helps maintain stable environmental conditions within the Laboratory Isolator, while simplifying day-to-day operation.
A developing direction in aseptic processing.
The Modular pure² approach reflects a broader shift in how aseptic Cell & Gene Therapy environments are being considered, moving away from fixed, single-purpose containment systems towards configurable platforms that can adapt alongside the process.
Rather than defining a single operating model, this type of system architecture allows containment to be structured around evolving workflows, with functionality introduced where and when it is required. This provides a more adaptable framework for applications where process complexity, scale, and handling requirements are still developing.
As Cell & Gene Therapy manufacturing continues to progress, the modular approach represents a practical direction for systems that need to support both current requirements and future change within a controlled GMP environment.
UK availability and Monmouth Scientific partnership.
SKAN’s pure² Isolator is available in the UK exclusively through Monmouth Scientific, combining SKAN’s isolator engineering expertise with Monmouth Scientific’s experience in clean air and containment systems.
The partnership provides access to configuration support, installation guidance, validation assistance, and ongoing technical service, ensuring the system is correctly specified and integrated for its intended application.
To discuss configuration options or explore how the SKAN pure² Isolator can be integrated into a specific process, contact Monmouth Scientific to speak with a specialist.