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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 SolutionsChamber 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 DistributionHomogeneous air + steam and temperature distribution are performed by the action of the recirculation fans on the top side of the chamber.
- Rapid CoolingRapid cooling of the product is performed through the jacket or heat exchangers installed inside the chamber, running with cold soft water.
- Easy MaintenanceThe machine is developed considering technicians’ access to the maintenance and service area – easy access to all components conforming to safety regulations.
- Remote AssistanceThe 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 PartsOnly 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.
A high-quality AISI 316 L stainless steel chamber guarantee long-term reliability and steam cleanliness. Chamber is provided with a jacket for fast and uniform heating and cooling of the load or a heat exchanger inside the chamber. The machine body is insulated with ceramic material, and external cladding stainless steel–piping is in compliance with ASME BPE made of AiSI 316L stainless steel with tri-clamp fittings. FDA components in contact with the product are of sanitary type - a 3.1 certificate can be provided.
Pure steam is used in the chamber for heating liquids. Over-pressure filtered air is injected into the chamber to compensate for the rising temperature and pressure inside the products. Internal fans ensure a uniform temperature distribution, between 110°C to 135°C, to avoid cold spots across the chamber. Rapid heating and cooling are standard phases. The treated items are completely dry at the end of the cycle.
Steelco has evolved its technologies to integrate its devices among themselves and into existing automation systems and, at the software level, to integrate naturally with the client's software and customer management systems. We can install new equipment into an existing automation system by adopting a simple (HMI) or more sophisticated (SCADA) man-machine interface, with complete customization of access levels available. In compliance with the individual internal policies of each customer, Steelco offers remote service access by using virtual private networks to ensure the confidentiality and safety of all transferred data. Customized automation solutions that that are wholly integrated with the client's IS system and comprehensive network services such as integration with MES can be provided.
Additional Products
Steelco AV Series Pharmaceutical Grade Saturated Steam Sterilizers are a fundamental part of the process used to render an object free from viable infectious agents, including viruses and bacterial spores.
The AVD Series combines all the features of a Pharma Grade Saturated steam sterilizer with the capability of performing bio-decontamination cycles using VH2O2.
Steelco’s range of autoclaves using superheated water are for the terminal sterilization of injectable solutions.
Steelco designs and manufactures a wide range of Class 100 static depyrogenation sterilizers (ISO 14644-1 class 5) to meet the most challenging pharmaceutical requirements.
Thanks to a long experience within the pharmaceutical, nutraceutical, cosmetic, and food industries, Steelco offers a wide range of hot air static dryers to meet the most challenging market requirements.
Sterile continuity is the vision. The SPE Series is ideal for treating closures for containers normally used in the pharmaceutical industry, where continuous sterility has to be maintained between different phases.
The DHP Series of Grade Decontamination air Lock is manufactured to provide a complete turnkey solution for the bio-decontamination of heat-sensitive equipment.
The AGS Series of sterilizers using Ethylene Oxide represents the best relationship between engineering and quality price, operating running costs, and, most important, the safety of the system and operators.