Pharma grade saturated steam sterilizers
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 vast experience acquired at Steelco Group in over thirty years of activity enables us to provide a highly diversified saturated steam sterilizer to meet the requirements of the most varied applications.
Built to a very high standard, each unit is tailored to the customer’s specifications. AV series is used to sterilize with clean/pure saturated steam materials such as vials, bottles, glass items, fabric materials, sealed or vented containers, rubber parts, machine parts, filters, etc.
The devices feature chamber volumes from 195 to 10.000 liters (7 to 353 cu ft) in several dimensions with configurable options. The AV Series of steam sterilizers are high-performing, reliable, and easy to use. Its sterilization cycle has been specifically designed to minimize time and energy consumption while maximizing efficiency and throughput.
The AV Series of saturated steam 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). 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)
Integrated automation architectures
Steelco can install new equipment into an existing automation system by adopting a simple (HMI) or more sophisticated (SCADA) man-machine interface. User-friendly control systems developed according to the latest ISPE GAMP© Guidelines and designed for FDA 21 CFR Part 11, EU Annex 11 compliance. System platforms available include Siemens or Rockwell/Allen-Bradley, which are completely integrated with the client's IS system, and comprehensive network services such as integration with MES can be provided. In addition, in compliance with the individual internal policies of each customer, Steelco Group offers remote service access by using virtual private networks to ensure the confidentiality and safety of all transferred data.
Reliable and hygienic construction
High-quality AISI 316 L stainless steel chamber and jacket guarantee long-term reliability and steam cleanliness. The chamber is self-draining with a cylindrical or rectangular cross section and covered by a full jacketed system of dimple welded type for fast and uniform heat transfer and optimization of chamber temperature distribution. The machine body is completely insulated with ceramic material and with external cladding stainless steel. Pipings in compliance with ASME BPE made of AISI 316L stainless steel with tri-clamp fittings and all machine components of sanitary type.
Complete layout versatility
Steelco offers a wide selection of saturated steam sterilizers to exceed industry standards, available in single or pass-through versions, with hinged or sliding doors. The AV Series provides flexible configuration and versatility. AV series saturated steam sterilizers can be configured as standard with different layout configurations:
- Loading configuration: floor mounted or pit mounted version.
- Electrical cabinet integrated within the skid of the equipment or remotely installed.
- Technical area: right/left solution or shared in case of "inline" equipment.
Sterilization cycle development
The sterilization cycle has been specifically designed to reduce time and energy consumption, improving efficiency and throughput. Each sterilizer can be equipped with any combination of cycles with complete flexibility to customize each phase and its parameters. All standard or custom cycle recipes are analysed and identified during design phase.
Quality engineering process and qualification services
Technical consulting, design, engineering, project management, as well as commissioning and qualification services of our equipment is offered, with customers appreciating the cost effective high performance solutions offered to resolve complex washing and sterilization challenges. Design qualification (DQ), Installation qualification (IQ), Operational qualification (OQ), and Performance qualification (Pa) are provided in standard version or customized according to the final scope of supply. Customers are always welcome to visit Steelco factories to see design and manufacturing methods and audit our processes. Steelco Group is available anytime to support customers during all acceptance on site including process development and mapping.