Product Description
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 provides an ISO 4.8 (Grade A) environment in the working area, ensuring aseptic conditions fully compliant with Good Manufacturing Practice (GMP) requirements for Cell & Gene Therapy manufacturing. ISOCell Pro integrates a CO₂ incubator directly into the isolator, enabling controlled cell handling and culture operations while simplifying validation and reducing overall operational costs.
The system features an automatic, fast, and safe decontamination process that is both efficient and economically sustainable, eliminating the need for specialized operator garments. Designed as a robust alternative to a Grade A environment within a Grade B cleanroom, ISOCell Pro supports clinical-scale cell processing and manipulation, offering a compliant, flexible, and cost-effective solution for advanced therapy medicinal product (ATMP) production.
Main Features and Benefits
- Lower total investment and operational costs
- User-friendly work environment
- Higher sustainability and reduced environmental impact
- Gene therapy medicinal products (GTMPs)
- Cell-based therapy medicinal products (CTMPs)
- Tissue-engineered products (TEPs)
- Combination products integrating medical devices
- Compliant with FDA, EUP, USP and industry guidelines lGMP, PDA, Eudralex vol. 4 Part IV, Annex 1
