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.

ISOCELL for Biobanking

Protecting biological samples through advanced barrier technology.

Biobanks play a fundamental role in the collection, storage and management of biological materials intended for research, diagnostics and therapeutic applications. Preserving sample quality and integrity requires controlled operating conditions and effective contamination risk management.

ISOCELL brings the benefits of isolator technology to tissue handling and processing activities, providing a closed and controlled environment that helps protect biological materials and improve process control.

Why choose ISOCELL for biobanking?

SAMPLE PROTECTION
A physical barrier between the sample and the external environment, helping reduce microbiological and particulate contamination risks during critical handling operations.

PROCESS CONTROL
A closed and controlled environment that supports process standardisation, reproducibility and qualification and validation activities.

COMPLIANCE SUPPORT
Technology that supports the implementation of controlled procedures and compliance with applicable quality standards and regulatory requirements for Tissue Establishments.

INFRASTRUCTURE AND COST OPTIMISATION
A solution that can reduce reliance on traditional classified environments, helping simplify the management of critical areas and optimise operating costs.

ISOCELL: a new standard of protection for biobanking

Integrating isolator technology into biobanking processes means adopting an advanced approach to biological sample protection, contamination control and operational efficiency.

With ISOCELL, IWT Pharma supports biobanks and Tissue Establishments in managing increasingly controlled, safe and sustainable processes.

Discover how ISOCELL can support your biobanking operations.

Contact us – Talk to our specialists.

ISOCELL for CAR-T Cell Therapy

Advanced isolator technology for safer, more controlled and efficient cell therapy processes.

CAR-T cell therapies are among the most advanced and promising applications in the field of Advanced Therapy Medicinal Products (ATMPs). Their manufacturing and handling require controlled environments, high safety standards and rigorous process management.

Expanding traditional cleanroom facilities is not always the most efficient solution. ISOCELL, IWT Pharma's isolator technology, offers an alternative approach based on a closed and controlled environment, designed to support CAR-T cell handling operations under sterile conditions and in compliance with applicable requirements.

Why choose ISOCELL for CAR-T applications?

PROCESS PROTECTION
A physical barrier between the operator and the external environment, helping reduce contamination risks and protect the product during critical processing steps.

PROCESS CONTROL AND COMPLIANCE
A controlled environment that supports standardised process management, as well as qualification, monitoring and validation activities.

INFRASTRUCTURE OPTIMISATION
A solution that can reduce reliance on traditional cleanroom facilities, simplifying the configuration of dedicated ATMP processing areas.

OPERATIONAL EFFICIENCY
Technology designed to optimise critical operations, helping reduce facility complexity and operating costs.

ISOCELL: a new approach to CAR-T processing

Through isolator technology, ISOCELL supports ATMP centres in implementing more controlled and efficient processes, offering an alternative technological approach to traditional classified environments.

Discover how ISOCELL can support your ATMP facility.

Contact us – Talk to our specialists.