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).

Sterilization machine AV Series pharma grade saturated steam sterilizers 1

Sterilization machine AV Series pharma grade saturated steam sterilizers 2

Sterilization machine AV Series pharma grade saturated steam sterilizers 3

Sterilization machine AV Series pharma grade saturated steam sterilizers 4

Sterilization machine AV Series pharma grade saturated steam sterilizers 5

Sterilization machine AV Series pharma grade saturated steam sterilizers 6

Sterilization machine AV Series pharma grade saturated steam sterilizers 7

Sterilization machine AV Series pharma grade saturated steam sterilizers 8

Sterilization machine AV Series pharma grade saturated steam sterilizers 9

Sterilization machine AV Series pharma grade saturated steam sterilizers 10

Sterilization machine AV Series pharma grade saturated steam sterilizers 11

Key Features

Door Gasket Door gasket made in a single piece of silicone rubber having a “Dove Tail” cross section, pneumatically pressurized by compressed air.
Safe Applications The unloading door can be interfaced with a HPV (hydrogen peroxide vapor) generator or isolation technology.
Heating Efficacy The 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 Sustainability Optimized for energy saving and low wastage. Drain cooling system available to cool down all effluents prior to discharge into drains.
Remote Assistance The 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 Testing The 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)

Cleaning and Sterilization Solutions Catalog (PDF)

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.