Workstations
The isolator has a front panel with four shoulder pads, which can be either:
- Circular with a diameter of 300 mm,
- – Oval with the same circumference as the shoulder pads (300 mm diameter).
Each workstation is equipped with:
- Two sleeves,
- Two wrist pads,
- One pair of ambidextrous neoprene gloves (sizes 6 to 8).
Les postes de travail seront prévus sur un plan incliné et pourront être pourvus d’un hublot par poste.
The shoulder straps will be oriented outwards to allow for easy replacement of the cuffs and gloves from the outside without compromising containment.
LED lighting is provided above each station of the isolator and is accessible from outside the enclosure.
Ventilation
The isolator is equipped with an inlet fan and an outlet fan. Each can be isolated by two valves during general sterilization. The minimum guaranteed flow rate in SIEVE France isolators is approximately 100 m³/h. The pressure is continuously measured and displayed on the control screen. This measurement allows for the detection of abnormal pressure drops and triggers an alarm.
Filtration
3P3 ULPA U15 panel filters will be installed in the upper part of the isolator. The following are planned:
- 1 inlet filter,
- 2 outlet filters.
The outlet filters are mounted in such a way that they can be replaced without compromising the integrity of the enclosure:
- One filter is removable from the inside,
- The other is removable from the outside and accessible via a sealed inspection hatch.
For information on their specifications and replacement, see the “Maintenance” section.
The Technical Unit
This technical unit will be located to the right of the isolator, relative to the front panel.
The stainless steel frame and casing provide a high-quality finish.
The technical unit contains the components necessary for the isolator’s operation:
- The sterilization chamber,
- The sterilization circuit,
- The sterilizing agent reservoir,
- The ventilation circuit
- The electrical cabinet.
The enclosure of these blocks offers several advantages:
- The machine’s control components are protected and inaccessible to personnel,
- Daily cleaning is easier as there are no areas where debris can accumulate,
- Machine noise is reduced by insulating foam bonded to the inside of the panels.
The electrical cabinet
The isolator’s electrical cabinet is integrated into the technical block. It consists of:
- A 12″ PLC display providing an interface for operators to control the isolator and record events occurring on the isolator (cycles, alarms, etc.),
- A VPN box connecting the PLC to an Ethernet network, enabling remote diagnostics and maintenance via our hotline support. This connection also allows the responsible pharmacist to connect to the machine with their computer without leaving their desk and enables them to:
- See what is happening on the isolator (cycles, alarms…)
- Retrieve backup files generated by the isolator (cycles, alarms, curves…)
- – A backup power supply connected to a battery guarantees the operation of your isolator with a minimum of one hour of autonomy, during which the isolator maintains its integrity by preserving its airtightness and ventilation.
Certain controls and displays are accessible on the front panel of the cabinet:
- Power on,
- Power indicator,
- Emergency stop (cuts off the electrical connections to the equipment inside the isolator),
- Machine status indicator,
- Cycle start control,
- The control screen,
- …
Sterilization Circuit
Le The airlock sterilization circuit consists of
- sterilization airlock,
- 1 blower with a flow rate of 50 m³/h,
- 1 air circuit made of rigid, pressure-bonded PVC tubing,
- 3 motorized valves to direct the airflow during the different phases of the sterilization cycles,
- 1 air inlet filter with an efficiency of 99.98% (H14),
- 1 evaporator (and outlet) filter with an efficiency of 99.98% (H14),
- 1 dosing system connected to the sterilizing agent reservoir.
The sterilization cycles for the airlock and isolator consist of the following phases:
- Containment of the areas to be sterilized with door locking control to prevent accidental opening,
- Dosing of the sterilizing agent,
- Positioning of the valves in the contact phase,
- Contact phase: vaporization of the sterilizing agent dose in the airlock (or isolator),
- Positioning of the valves in the rinsing phase,
- Rinsing phase: renewal of the atmosphere in the sterilized volume with filtered air.
Sterilizing Agent Reservoir
To protect personnel, SIEVE offers a sterilizing agent reservoir where the operator does not come into contact with the product during filling.
