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Pharma Grade Steam and Air Mixture Sterilizer
Réf : AMS Series | Fabricant : Steelco
The AMS steam and air mixture sterilizer is used to sterilize liquid products in sealed containers such as Large Volume Parenterals (LVP) in bottles, bags, BFS or FFS packaging or Small Volume Parenterals (SVP) in vials, ampoules or prefilled syringes (PFS). This process prevents damage or deformation of product sensitive containers or packaging materials.
A counter pressure of compressed air is applied to maintain a pressure equilibrium across containers and avoid their deformation. The homogeneous steam and air mixture is recirculated around the load by a fan to ensure uniform heating and cooling with no temperature stratification across the load.
Principales caractéristiques
- Chamber size is from 830 to 25.000 liters (29 to 883 cu ft)
- Optimal Temperature Distribution: homogeneous air + steam and temperature distribution are performed by the action of the recirculation fans on the top side of the chamber.
- Rapid Cooling: rapid cooling of the product is performed through the jacket or heat exchangers installed inside the chamber, running with cold soft water.
- Easy Maintenance: the machine is developed considering technicians’ access to the maintenance and service area – easy access to all components conforming to safety regulations.
- Remote Assistance: the onboard VPN router communicates with the PLC and the HMI on the local network. It allows remote connection from a computer, tablet, or smartphone without going on-site, drastically reducing support costs and improving machine uptime.
- Non-Proprietary Parts: only proven, non-proprietary automation components and systems are available worldwide.
Spécifications
• Pharmaceutical standards:
- 21 CFR Part 11 / EU Annex 11
- 21 CFR Part 210-211 / EudraLex Volume 4
• Material traceability: EN 10204
• Electrical / EMC: EN IEC 61326 / 61000
• Safety:
- EU Machinery directive
- EN IEC 61010 / 60204-1 / 61310
EN ISO 12100 / 349 / 13850 / 13857
- UL
• Pressure vessels: PED / ASME or other applicable code