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).
Reliable and Hygienic Construction
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—pipings 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 are wholly integrated with the client’s IS system and comprehensive network services such as integration with MES can be provided.
Workflow Optimization and Load Handling
Steelco’s extensive experience assists customers in increasing process productivity and quality with improved ergonomics while limiting costs. Semiautomatic or fully automated conveyor systems for loading and unloading racks and integration with robots are available to optimize workflow and maximize productivity. In addition, loading racks made of AISI 316L stainless-steel equipped with a guide for shelves positioning can be provided with automatic push and pull device guides to be installed inside the chamber.
Quality Engineering Process and Qualification Services
Our equipment’s technical consulting, design, engineering, project management, and commissioning and qualification services are offered, with customers appreciating the cost-effective, high-performance solutions provided to resolve complex washing and sterilization challenges. Design qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are provided in a standard version or customized according to the final scope of supply. In addition, customers are always welcome to visit Steelco factories to see design and manufacturing methods and audit our processes.
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 of the product is performed through the jacket or heat exchangers installed inside the chamber, running with cold soft water.
The machine is developed considering technicians’ access to the maintenance and service area – easy access to all components conforming to safety regulations.
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.
Only proven, non-proprietary automation components and systems are available worldwide.
Remote FAT service
In order to support the equipment verification procedures for our clients, we then introduce an alternative way to perform FAT – Factory Acceptance Testing, usually realized onsite. Remote FAT is a smart cloud-based service to support customers step by step in all procedures and testing and the production of related documentation that can be executed remotely, reducing the time required for staff to be away from the office and the associated costs including travel, accommodation, visa application, etc.
Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
- GAMP 5
- FDA Regulation 21 CFR Part 11, 211, 820
- ASME BPE
- PDA Technical Report
- European and US Pharmacopeia
- ISPE Guidelines
- UL and CSA (on demand)
from 830 litres / 29 cu ft
to 25.000 litres / 883 cu ft
Custom dimensions available upon request.
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.
Bulk Stopper Manufacturing
“Ready to Sterilize” or “Ready to Use” closures have to be processed and packaged in bulk at point of manufacture, before being delivered to the drug manufacturer. Steelco and its ICOS production site provide cleaning / siliconising / sterilizing equipment to major stopper manufacturers and bulk users.
Terminal Sterilization of Parenteral Drugs
A wide and customizable range of equipment to sterilize bulk and heavy drugs without damaging the packaging integrity. Optimized processing with maximum operational efficiency.