EVERYTHING YOU NEED FOR CELL AND GENE THERAPY PRODUCTS AT YOUR HAND
Producing advanced therapy medicinal products (ATMPs) for therapeutic purposes is a complex task, for which aseptic conditions are only one part of the requirement. Apart from the clean room zone itself, you need trained operators and strict procedures to prepare the room and the people involved to be ready for the process. This requires huge efforts in terms of infrastructures, personnel training and compliance.
Bioair, with its ISOCell PRO Cell Therapy Isolator, can be the answer to your needs by providing a streamlined workflow environment reducing the set up and running costs of cell therapy products preparation while still operating within the restrictive confines of various regulatory bodies (FDA, EUP, USP) and industry guidelines (GMP, PDA).
- Simplicity of the ISO 5 location and easy gowning for most applications since isolator systems dedicated to cell production may be located in a Class D room with restricted access;
- Security with validated sterility of the working area and cross-protection of product/operator/environment.
- Traceability for all the steps of the sterile handling process.
- The initial sterility is provided by a dedicated H2O2 vapor (HPV) program to bio-decontaminate the work area and the material access area
The main working area is classified as class A according to GMP/EU, the aeraulics are designed to provide a unidirectional flow within both the main working area and the transfer hatch.
Integrated CO2/O2 Incubator
The incubator is a custom device designed to fit into an isolator.
A microscope is included in the working area to allow fast and easy observation of the cell and tissue sample without the need to leave the clean area.
Integrated Waste System
The bin is placed below the isolator and has an opening port inside the working area between incubator and microscope.
In order to guarantee a sterile environment, the ISOCell PRO is designed to allow sterilization with hydrogen peroxide vaporisation.
Important parameters are monitored and may be recorded.