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GMP Cleaning, Isolation and Decontamination Systems for the Pharmaceutical Industries.

ASEPTICARE - Multipurpose Isolator

Features

Flexible Aseptic Solution: ASEPTICARE offers a versatile, closed aseptic environment, ideal for aseptic and aseptic-toxic operations. It ensures contamination control and improves operational efficiency across various sterile processes.

Component Preparation: Safely transfers components such as EM plates, change parts, and consumables into filling lines while maintaining a sterile environment.

Aseptic Formulation: Enables the sterile formulation of both sterile and sterile-toxic products, including vaccines and other suspension products.

Small Scale Filling: Suitable for automatic or semi-automatic filling and finishing of small batches, including vials, PFS, IV bags, and medical devices.

Flexible and Modular: The modular design allows for easy customization without the need for construction work or HVAC connections, simplifying installation and setup.

Fast, Efficient Decontamination: Integrated H2O2 catalyzers facilitate rapid decontamination cycles, reducing downtime and improving productivity.

Custom Solutions: Provides validated, tailored solutions for seamless integration of equipment and devices, all controlled through a smart, unified system.


Further Information

BROCHURES & DOCUMENTS

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ASEPTICARE - Multipurpose Isolator



APPLICATIONS

  • Component Preparation: Components such as EM plates, change parts, and consumables for transfer to filling lines.
  • Aseptic Formulation: Sterile formulation of sterile and sterile-toxic products (such as vaccines) or other suspension products.
  • Aseptic Small Batch Filling: Automatic or semi-automatic filling of small batches (vials, PFS, IV bags, medical devices).

ACCESSORIES

GLOVECARE

Automatic Glove Integrity Tester for Isolators

In aseptic processing, glove integrity is a critical element of the contamination control strategy.
Within isolators and RABS, gloves represent the primary interface between the operator and the Grade A environment and must be routinely verified to ensure barrier integrity and regulatory compliance.

GLOVECARE is IWT’s automatic glove integrity tester, designed to deliver reliable, repeatable and fully traceable glove testing in accordance with EU GMP Annex 1 and ISO 14644‑7 Annex E.5 requirements.

Key features & benefits

  • Automated pressure decay glove integrity testing with validated methodology
  • Detection of micro‑perforations down to 100 μm
  • Fast testing cycles with minimal impact on aseptic operations
  • Full electronic data traceability, compliant with cGAMP and 21 CFR Part 11
  • Seamless integration with isolator control systems and digital architectures
  • Portable design for flexible deployment in cleanroom environments

Compatibility

GLOVECARE is fully compatible with all IWT isolator platforms, including aseptic processing, sterility testing and ATMP applications.
Thanks to interchangeable flanges, it can also be used on isolators and RABS from any manufacturer.

OPEN GLOVECARE BROCHURE

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