AMS Series Pharma Sterilizer – Pharma Grade Steam-Air Mixture Sterilizers

The AMS Series pharma sterilizers are pharmaceutical-grade autoclaves engineered for terminal sterilization using advanced steam-air mixture technology. Designed specifically for treating pharma-grade materials and products that require rapid drying and immediate readiness for further handling, this sterilization method protects pressure and heat-sensitive materials from damage.

Optimal air ventilation ensures uniform temperature distribution throughout the sterilizing chamber during all process phases. This makes the AMS Series ideal for sterilizing liquids in sealed or heat-sensitive containers, including:

Bottles, ampoules, and vials
Semi-open containers and bags
Blister packs and prefilled syringes
Pouches and contact lenses
Large-volume and small-volume parenteral products (LVP and SVP)

Flexibility and versatility define the AMS Series, with devices available in various chamber sizes—ranging from 830 to 25,000 liters (29 to 883 cu ft). The chambers feature horizontal sliding double doors controlled by an electromechanical device, ensuring smooth operation. A silicon, FDA-compliant, swallowtail gasket—pneumatically pressurized by compressed air—guarantees door tightness.

The AMS Series pharma sterilizers are designed, manufactured, validated, and documented in accordance with the latest global standards, facilitating compliance with current Good Manufacturing Practices (cGMPs). These sterilizers provide the pharmaceutical industry with a reliable solution for handling sensitive products while maintaining efficiency and quality throughout the sterilization process.

Sterilization Decontamination Pharma Sterilizer - AMS Series Steam Air Mixture

Pharma Sterilizer for Decontamination - AMS Series Steam Air Mixture

AMS Series Pharma Sterilizer - Steam Air Mixture for Decontamination

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)

Cleaning and Sterilization Solutions Catalog (PDF)

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.

AV Series Pharma Grade Saturated Steam Sterilizers

AVD Series Pharma Grade Saturated Steam Sterilizer and Bio-Decontamination with VH2O2

ASW Series Pharma Grade Superheated Water Sterilizers

SD Series Pharma Grade Depyrogenation Ovens

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.