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AV Series 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).
Key Features
- Door GasketDoor gasket made in a single piece of silicone rubber having a “Dove Tail” cross section, pneumatically pressurized by compressed air.
- Safe ApplicationsThe unloading door can be interfaced with a HPV (hydrogen peroxide vapor) generator or isolation technology.
- Heating EfficacyThe machine body is insulated with ceramic material and with an external cladding of stainless steel, providing even and fast heating thus reducing cycle times.
- Environmental SustainabilityOptimized for energy saving and low wastage. Drain cooling system available to cool down all effluents prior to discharge into drains.
- Remote AssistanceThe on-board VPN router communicates on the local network with the PLC and the HMI, and allows remote connection from a computer, tablet, or smartphone without going on-site, drastically reducing support costs and improving machine uptime.
- Easy TestingThe front loading side is fitted with connection ports for easy validation testing.
High-quality ASI 316L 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. Piping is in compliance with ASME BPE made of AISI 316L stainless steel with tri-clamp fittings and all machine components of sanitary type.
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 configurations: floor mounted or pit mounted versions
- Electrical cabinet integrated within the skid of the equipment or remotely installed
- Technical area: right/left solution or shared in case of "inline" equipment
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.
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 195 litres / 7 cu ft
to 10.000 litres / 353 cu ft
Custom dimensions are 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 a steam generator.
Additional Products
The AVD Series combines all the features of a Pharma Grade Saturated steam sterilizer with the capability of performing bio-decontamination cycles using VH2O2.
The AMS Series of Pharmaceutical Grade Steam-Air Mixture sterilizers is a range of autoclaves designed for terminal sterilization using steam air mixture technology.
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.