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

ISOCARE - Sterility Testing Isolator

Features
  • EU-GMP Class A (ISO 5) Compliance: ISOCARE guarantees a sterile, compliant environment for sterility testing, meeting the highest pharmaceutical industry standards.
  • Automatic Decontamination: IWT's proprietary decontamination system ensures ultra-rapid 6-log microbial reduction, optimizing process efficiency and minimizing downtime.
  • Modular, Plug & Play Design: The flexible design allows for easy customization to meet specific operational needs, ensuring smooth installation and adaptation to existing workflows.
  • Predefined Configurations: Engineered for quick deployment, reducing time to market and providing an efficient, streamlined setup process.
  • Compact and Sustainable: The compact design fits into space-constrained environments while minimizing environmental impact through energy-efficient operations.
  • Enhanced Safety: Offers robust protection for both operators and products, ensuring a safe environment for aseptic and aseptic-toxic processes.
  • Italian Engineering Excellence: Crafted with high-quality, durable materials and backed by Italy's renowned engineering expertise for long-lasting performance and reliability.
  • Advanced Control System: Equipped with a state-of-the-art control system that boosts operational efficiency with real-time monitoring, ensuring optimal performance throughout the process.

Further Information

BROCHURES & DOCUMENTS

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ISOCARE - Sterility Testing Isolator



CARE FOR

QUALITY

  • ISOCARE ensures the highest level of product and operator protection for aseptic and aseptic-toxic operations.
  • Crafted with Italian manufacturing expertise, it integrates cGMP standards and Quality by Design (QbD) principles to elevate operational performance.

 

 

ENVIRONMENT

  • Exceptionally compact, ISOCARE fits into EU-GMP Class D environments, reducing operational and energy costs.
  • Its sleek, dust-free design simplifies cleaning and maintenance, improving accessibility during operation and maintenance activities.

 

 

PROCESS

  • ISOCARE features a modular and flexible design, tailored to specific requirements with a Plug&Play system for quick installation.
  • Predefined configurations expedite time-to-market for rapid deployment.

 

 

OPERATORS

  • Human-centric design principles improve operator comfort, enhancing ergonomics and reducing strain and fatigue during daily operations.
  • This approach improves concentration on critical process details, enhancing productivity.

 

 

SAFETY

  • ISOCARE ensures the highest level of protection for both products and operators.
  • The advanced SCADA system integrates with MES through UPC UA, complying with 21 CFR Part 11 and GAMP5 standards for seamless process control.

 

 

PARTNERS

  • Dedicated Project Management and customer support teams assist during the project development phase.
  • Continuous support from qualified validation experts and training opportunities at our TAC Training Activity Center.
  • We provide local resources, spare parts, and swift interventions globally to ensure effective communication and support.
 
 

SMARTCARE & LIGHTCARE

SMARTCARE

  • SmartCare is a patent-pending system that projects operational instructions using Augmented Reality, minimizing errors and enhancing productivity.
  • Track & Trace every process step to reduce risks, while the SMARTCARE platform supports supervision, training, and support.

 

LIGHTCARE

  • LightCare is an intelligent lighting system, patented by IWT, that introduces dynamic lighting control for isolators.
  • Personalized lighting adjustments enhance operator well-being, improving productivity and operational efficiency by aligning with circadian rhythms and process needs.

 

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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