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ASW Series Pharma Grade Superheated Water Sterilizers
Demander plus d'information ›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).
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.
Chamber and internal door(s) are entirely made in AISI 316L stainless steel. Sterilization chamber of round cross-section, containing all the accessories for its use with superheated water. The design of the lower part of the chamber allows complete drainage, and it is fitted with guides for moving the product holding carts. All piping in AISI 316L stainless steel, orbital welded (where possible). FDA components in contact with the product are of sterile type - a 3.1 certificate can be provided.
Water is continuously circulated through the system and cascades over the load using spray nozzles, a high capacity pump, and large diameter piping to ensure high water flow rates. The recirculating water is heated and cooled by external heat exchangers. Meticulous control of heating and sterilization is achieved by superheating the water using modulated steam. Compressed air at overpressure is injected to compensate for the rising temperature and pressure inside the products when heated. The cooling phase brings the product down to ambient temperature by continuously spraying the recirculating water over the load.
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