Installation Description
Each unit will consist of:
- A transfer and sterilization isolator
- A production and storage isolator
- Exit and emergency airlocks
Filtration/Ventilation Circuit
Each isolator is equipped with 2 filters (1 inlet and 1 outlet). The characteristics of the filters used are:
- Type: ULPA (Ultra Low Particulate Air),
- Model: 3P3 (305×305 mm)
- iency EN 1822:2009: U15,
- MPPS (Most Penetrating Particulate Size) Efficiency: >>99.9995%,
- 100% incinerable (Sustainable product)
Sterilization Circuit
Each sterilization circuit operates in the same way. It consists of:
- A blower with a flow rate of 50 m³/h,
- An air circuit made of rigid, pressure-bonded PVC tubing,
- Motorized valves to direct the airflow during the different phases of the sterilization cycles,
- An air inlet filter with an efficiency of 99.98%,
- An evaporator filter with an efficiency of 99.98%,
- A dosing system connected to the sterilizing agent reservoir.
The dosing system consists of:
- Two solenoid valves: one for dosing and one for injecting the dose,
- Two capacitive sensors indicating the high and low dose levels.
The dosing circuit is made entirely of PTFE and 316L stainless steel, materials highly resistant to chemical attack and therefore very well suited to our application.
Sterilizing Agent Reservoir
To protect personnel, SIEVE France offers a sterilizing agent reservoir where the operator does not come into contact with the product during filling.
Operating Procedure:
- Remove the cap from the sterilizing agent bottle,
- Screw the bottle onto the suction cap,
- Place the bottle on the support,
- Control the reservoir filling on the control screen (see the “Operator Manual”).
The filling process is automatic and can be stopped manually using the control screen or will stop automatically:
- When the maximum level is reached,
- After a preset time.
Peracetic Acid Vapor Neutralization Unit
SIEVE France pays particular attention to environmental protection. Therefore, when peracetic acid is the chosen sterilizing agent, a peracetic acid vapor neutralization unit is systematically installed at the outlet of the sterilization circuit’s exhaust duct to prevent odor emissions.
This unit is equipped with one or two activated carbon filters (depending on the model). The unit must be located in an easily accessible technical area to allow for filter replacement. Replacement is performed during maintenance, on average every six months.
The electrical cabinet
It is integrated into the technical units and includes:
- 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.
Sterilization System
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
Waste Container
The waste container is a new product in the SIEVE France range.
It consists of a DPTE Ø105 container head, equipped with its door and sealing gasket. A 40-liter EVA bag is mounted on the head.
The entire assembly is radio-sterilized and packaged in a plastic bag.
For the operator, it is simply a matter of locking the container onto the secure cell flange installed in the production isolator. When the bag is full, the container is unlocked for disposal in the hospital waste.
