Ventilation System
The isolators in our IM range are equipped with a ventilation and extraction system that ensures air exchange rates exceeding 80 volumes per hour.
- IM 1222: 80 volumes per hour
- IM 2111 and IM 1111: 120 volumes per hourIM 2111 et IM 1111 : 120 volumes / heure
This system is fully automated and allows for operation under positive pressure (recommended for sterile medications) or negative pressure.
Filtration System
Our IM isolators are equipped with ultra-high-efficiency ULPA (U15) filters (NF EN 1822-4 standard) at the air inlet and outlet, with an efficiency of 99.9995 at 0.3µ.
Our machines thus meet the regulatory (GMP and GBF) and normative (NF ISO 14644 and NF S 90-351) requirements of ISO Class 5.
Transfer airlock (inlet/outlet function)
Each isolator is equipped with a sterilization airlock for transferring materials and products.
Each airlock is independent and managed by the automated system, allowing production to continue in the event of a malfunction.
Entry airlock
Each airlock allows the introduction of preparation-related products, with a capacity of 4 baskets per airlock.
The airlocks are equipped with rails to facilitate transfer operations (loading/unloading).
The airlocks are sealed using inflatable gaskets.
The complete cycle (contact with the sterilizing agent and rinsing cycle) is performed in “flash” time.
Sterilization System
The isolators in our IM range can operate with two sterilizing agents:
- Peracetic Acid (PAA),
- Hydrogen Peroxide (H2O2).
Our sterilization system uses filter sterilization (through a BAG filter).
Our system also eliminates the need to heat the sterilizing agent.
Sterilization efficiency is ensured by circulating the sterilizing agent throughout the volume.
- For entry airlocks: 800 R/h,
- For exit airlocks: 8,000 R/h,
- For a 2-station isolator: 110 R/h
- For a 1-station isolator: 80 R/h
Sterilizable Rapid Exit Airlock
These airlocks allow for the very rapid removal of preparations while maintaining the integrity of the isolator.
The airlock volume is sterilized (contact cycle with sterilizing agent and air rinsing cycle) and not simply ventilated (exit hatch), thus guaranteeing the safety of personnel and products by preventing contamination of the isolator and the environment.
The airlocks are sealed using inflatable gaskets.
Additional Advantages of IM Isolators
Easy operation via a touchscreen and a simple, functional graphical interface.
Different operating modes depending on the operator (pharmacy technicians, pharmacists, or other technicians).
Cycle data is archived on an internal hard drive, with the option to retrieve data via the healthcare facility’s network or directly from the machine using a USB drive.
Our machines also benefit from remote maintenance (SSL VPN type) enabling:
- Monitoring (remote control)
- Diagnostics (remote diagnostics)
- Troubleshooting (remote intervention or remote troubleshooting).
Our machines are installed in accordance with quality procedures, including installation and operational qualifications. Our company remains available to assist healthcare facilities in implementing performance qualifications.
