AMS Series

Pharma Grade Steam-Air Mixture Sterilizers.

The AMS Series of Pharmaceutical Grade Steam-Air Mixture sterilizers is a range of autoclaves designed for terminal sterilization using steam air mixture technology. Specially designed for the treatment of pharma grade materials and products that must be dry and arranged for further handling promptly after cooling, this sterilization method avoids any damage to pressure and heat-sensitive materials.

An optimal air ventilation maintains the temperature uniform in the sterilizing chamber during all process phases. These features make it suitable for sterilizing liquids in sealed or heat-sensitive containers, such as bottles, ampoules, vials, semi-open containers, bags, blister packs, prefilled syringes, pouches, contact lenses, and large sizes and small-volume parenteral (LVP and SVP).

Flexibility and versatility characterize the series devices available in different chamber sizes – chamber volume ranging from 830 to 25.000 litres (29 to 883 cu ft). The chamber is equipped with horizontal sliding double doors and the movement is controlled by an electromechanical device. The door tightness is guaranteed by gasket in Silicon FDA compliant swallowtail pneumatically pressurized by compressed air.

The AMS Series of Pharma Grade Steam-Air Mixture Sterilizers is designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customers’ compliance with current Good Manufacturing Practices (cGMPs).

Key Features

Flexible Solutions

Chamber size is from 830 to 25.000 liters (29 to 883 cu ft). Steelco Group is always available to customize machine dimensions upon customer-specific needs and requirements.

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.

Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:

  • cGMP
  • GAMP 5
  • FDA Regulation 21 CFR Part 11, 211, 820
  • Eudralex
  • ASME BPE
  • PDA Technical Report
  • European and US Pharmacopeia
  • ISPE Guidelines
  • UL and CSA (on demand)

Chamber volume

from 830 litres / 29 cu ft
to 25.000 litres / 883 cu ft

Custom dimensions available upon request.

 

Overall dimensions

The overall dimensions may vary according to machine configuration and customer requirements. An electrical cabinet may be installed remotely from the machine as well as a steam generator depending on space and operational requirements.