Isocell  - Advanced cGMP isolator 

BROCHURES & DOCUMENTS

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SERVICES & APPLICATIONS

SERVICES

IWT isolators provide a controlled, GMP-compliant environment for the safe handling of Advanced Therapy Medicinal Products (ATMPs). Our services ensure full compliance with regulatory requirements, streamlining qualification processes and optimizing production efficiency.

• Design Qualification (DQ): Validation of project compliance with GMP and User Requirement Specifications (URS).
• Installation & Operational Qualification (IQ/OQ): Verification of installation, functionality, and process parameters to ensure regulatory adherence.
• SCADA system integration: Full compliance with FDA CFR-21 Part 11 for data integrity and traceability.
• Process workflow optimization: Minimization of contamination risks and efficiency improvement in ATMP manufacturing.

Our expertise ensures a seamless validation process, reducing qualification time and ensuring the highest standards in ATMP production.

APPLICATIONS

ISOCellPRO® is designed as a Closed System (AinD) to comply with the strict requirements of regulatory bodies such as FDA, EUP, USP and industry guidelines like GMP, PDA, Eudralex vol. 4 Part IV, Annex 1. Compared to Open Systems, it offers several advantages:

• Lower total investment and operational costs
• User-friendly work environment
• Higher sustainability and reduced environmental impact

The evolution of molecular biology and stem cell differentiation has expanded the potential of Advanced Therapy Medicinal Products (ATMPs), including:

• Gene therapy medicinal products (GTMPs)
• Cell-based therapy medicinal products (CTMPs)
• Tissue-engineered products (TEPs)
• Combination products integrating medical devices

ISOCellPRO® supports the development and production of ATMPs, ensuring regulatory compliance and process efficiency.

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

IsocellBIOBOX

Closed transfer system for ATMPs productions or applications requiring a strictly controlled bioconfinement:

• Made in a special moulded plastic material PSU or PPSU that are known for their toughness and stability at high temperature: PSU (160°C) – PPSU (180°C).
• It is possible to autoclave more than 500 times the plastic parts at 121°C – 134°C.
• The HEPA filter membrane is a consumable part resistant to thermal and/or chemical sterilization cycles (H2O2), equipped with an HEPA filter membrane that allows gas exchange (CO2 and O2) but avoids the possibility of external particulate contamination entering the airtight container.
• The HEPA filter membrane is a Microbiological filter (H14 as per UNI EN1822-1:2019).
• Drastically reduces equipment costs, compared to other solutions that use specially designed CO2 incubators.

Applications

IsocellBIOBOX represents a unique, reliable, GMP compliant, low-cost, easy-to-use system that guarantees the bio-confinement of the samples in the same aseptic conditions as in the Grade A area of the Isolator, during the transfers of semi- or finished products when these products are moved outside of the Grade A Isolator across the external Grade C or D environment in order to be placed into external incubators or other equipment.