The IsoCell Pro is an Integrated Cell Processing Workstation designed for the aseptic production of cells and tissues within a GMP Grade A compliant environment:
- Highly efficient use of space, energy and capital investment.
- Provides a closed, self-contained and safe environment.
- Fully GMP Compliant with proven IQ, OQ and PQ validation.
The IsoCell Pro is a GMP compliant device which fully integrates:
- An airlock chamber (SAS) that allows material to be passed between the outer GMP Grade D laboratory and the inner GMP Grade A work area. This serves as an airlock chamber in which material can be unpacked and prepared for entry into the working area in a controlled manner.
- An evacuation waste point for packaging waste in the airlock chamber.
- A main GMP Grade A chamber which is sub divided into two spaces:
– Main working area
– Microscope area for the observation of cell cultures - A CO2 incubator for the maintenance of cultures.
- An evacuation waste point within the main working area that maintains sterility.
- H2O2 decontamination.
Applications:
The spectrum of applications for the IsoCell Pro cell processing workstation is growing rapidly as science progress.
Public and private institutions serving the clinical, life science, biotechnology and pharmaceutical markets that research or deploy GMP approved cellular therapeutics can benefit from the efficiency offered by the Isocell Pro. Example applications include, but are not limited to:
- Cellular manipulation and growth.
- Cell product extraction and emerging processes.
- Organ and tissue regeneration such as skin, cartilage, muscle and liver regeneration.
- Immunotherapy application which may include T-cells, dendritic cells, Mesenchymal stem cells & Lymphocyte expansion.
Comparison between Traditional Cleanroom and IsoCell Pro Solutions:
|
OPEN SYSTEM Cleanroom with Safety Cabinets |
CLOSED SYSTEM IsoCell Pro |
|
| System Type |
Large Open System Large GMP grade B and C cleanrooms with biological safety cabinets (GMP grade A) |
Small Closed System Small GMP grade D cleanroom IsoCell Pro (GMP Grade A) |
| Space Requirement |
Dedicated facility with significant requirement for HVAC plant, large air volume flows and multiple cleanrooms |
Minimal footprint installed into an existing space. Installation is possible with a simple cleanroom plus lobby. |
| Operational Cost |
High running and maintenance costs, higher decontamination and consumables cost |
Low |
| Validation |
Complicated, time consuming and costly. Extensive environmental monitoring required. |
Easily validated, automated process with integrated environmental monitoring |
| Security |
Complicated decontamination, shared instrumentation in an open system exposes processes to cross contamination |
Rapid decontamination is possible in 2 hours. Microscopes and incubators are dedicated to the system. |
SCADA Managment & Control System:
The IsoCell Pro has an integrated Supervisory Control and Data Acquisition (SCADA) managment system that complies with the GAMP requirements and 21 CFR part 11 relating to data registration.
The managing system provides;
- Facility for the user to navigate easily and control his/her activity within the module.
- Transmission of parameters and necessary data in order to guarantee the traceability of production.
The operator interface is a 15” Siemens panel PC with integrated touchscreen and USB port for the connection of a barcode scanner for the efficient implementation of a data, material and product transfer record system.
The system continuously monitors, records and exports (to LIMS) the following parameters:
- Temperature
- CO2 concentration
- CO2 flowrate
- Humidity
- Rate of decontamination
- Tracks decontamination agents after internal decontamination
- Area differential pressures
Other Key Features:
- Integral CO2 Incubator.
- Inlet vacuum (suction of fluids).
- Decontamination system using hydrogen peroxide (H2O2) to decontaminate the main and transfer chambers independently.
- Liquid retaining work surface.
- Front sash can be opened for installation of bulky equipment (during unit installation).
- Electrically operated transfer hatch door to transfer samples and equipment in and out.
- Foot pedal driven entrance door and motorised tray system.
- LCD microscope
