ASW Series

Pharma Grade Superheated Water Sterilizers.

Steelco’s range autoclaves using superheated water are for the terminal sterilization of injectable solutions. This sterilization method avoids damage to the processed liquid material and their containers, including heat-sensitive materials. It is used to sterilize liquids in sealed or heat-sensitive containers such as bottles, ampoules, vials, semi-open containers, infusion bags, blister packing, pockets, contact lenses, LPV’s, etc., and also for the pasteurization of products like blood plasma.

The ASW Superheated Water Sterilizer is available in several chamber sizes – chamber volume ranges from 830 to 25.000 liters (29 to 883 cu ft) – with the possibility of customizing dimensions upon customer-specific requirements. The chamber is equipped with horizontal sliding double doors, and an electromechanical device controls the movement. A gasket guarantees the door tightness in Silicon FDA compliant swallowtail pneumatically pressurized by compressed air.

The ASW Series is designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customer 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

Uniformity of temperature guaranteed by high capacity recirculation pump action.

Environmental Sustainability

Optimised for energy saving & low wastage with recirculation water cooling system.

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, globally available components and automation systems. Steelco provides full details for every element allowing customers to source spare parts either from Steelco or the original equipment manufacturer.

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. Depending on space and operational requirements, an electrical cabinet may be installed remotely from the machine and steam generator.