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

Isocell  - Advanced cGMP isolator 

Features

ISOCell PRO, a Cell Therapy Grade A Isolator alternative to the use of A in B clean room environment. Indeed, IsoCell Pro is a Closed System that requires ISO 8 – Class 100,000 – Grade D surrounding environment.

  • The Positive Pressure Isolator guarantees ISO 4.8 – Grade A environment in the working area with aseptic conditions according to GMP.
  • ISOCell Pro has an integrated CO2 incubator that makes the system easily validated at affordable costs. The decontamination process is automatic, fast, safe, and economically affordable, and special operators’ clothes are not needed.
  • ISOCell Pro is a valid alternative to the working environment A in B clean room: ISOCell PRO represents an interesting.
  • Good Manufacturing Practice compliance for cell clinical production that is even more advantageous in terms of reducing costs.

Further Information

BROCHURES & DOCUMENTS

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Isocell - Advanced cGMP isolator 



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.

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.

 

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