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

The AVD Series combines all the features of a Pharma Grade Saturated steam sterilizer with the capability of performing bio-decontamination cycles using VH₂O₂. Sharing the same chamber, utilities, and control system, this multipurpose device requires less space and operating cost compared with two independent and dedicated units – one saturated steam sterilizer and one decontamination airlock.

Built to a very high standard, each unit is tailored to the customer’s specifications. AVD series sterilizes with clean/pure saturated steam materials such as vials, bottles, glass items, fabric materials, sealed or vented containers, rubber parts, machine parts, and filters. Using VH₂O₂ technology provides a complete turnkey solution for the bio-decontamination of heat-sensitive equipment such as packaged single-use materials, packaged drug delivery devices, empty laboratory glassware, packaged stainless steel instruments, machine parts, small stainless steel containers, electronic devices, various laboratory materials made of glass or plastic or any other material composed of parts compatible with VH₂O₂ to be transferred from one classified area to another.

Available in single or double doors versions with hinged or sliding horizontal door(s) opening system. The devices feature chamber volumes from 195 to 10.000 liters (7 to 353 cu ft) in several dimensions with configurable options. The AVD Series is high-performing, reliable, and easy to use. Its sterilization and decontamination cycles have been specifically designed to minimize time and energy consumption while maximizing efficiency and throughput.

The AVD Series 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 decontamination pharma grade saturated steam sterilizer AVD Series 1

Sterilization decontamination pharma grade saturated steam sterilizer AVD Series 2

Sterilization decontamination pharma grade saturated steam sterilizer AVD Series 3

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.
Maximum Safety Fully designed with operators’ and instruments’ safety in mind. Two H2O2 detection sensors ensure that no gas residues are still present and that the aeration has been properly carried out.
Environmental Sustainability Optimized for energy saving and low wastage. Drain cooling system available to cool down all effluents prior to discharge into drains.
Easy Testing The front loading side is fitted with connection ports for easy validation testing.
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 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.

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.

AV Series Pharma Grade Saturated Steam Sterilizers

ASW Series Pharma Grade Superheated Water Sterilizers

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

SD Series Pharma Grade Depyrogenation Ovens

The vaporization process of the liquid hydrogen peroxide is performed through an onboard generator fully integrated into the technical area of the leading equipment. A ventilation system guarantees a uniform H₂O₂ distribution in the chamber and on the load, assuring a fast aeration phase and higher throughput. Following the low-temperature treatment, the decontamination reaches the sterility assurance level (SAL) values up to 10^-6.

The onboard generator prepares the correct does of H₂O₂ and delivers it to the vaporizer system. The Liquid H₂O₂ is delivered from a canister, which may be easily exchanged via an alcove in the facial panel from the loading side. A precise load cell verifies the consumption of H₂O₂ for each cycle and the number of chemicals left in the canister. If the level is insufficient, the process controller advises the operator to replace the canister.

Once the bio-decontamination process is complete, to reduce the concentration of H₂O₂ below the permitted set point, a fast aeration phase is performed by injection of fresh filtered air (HEPA filter with H14 ≥ 99.995% MPPS efficiency) into the chamber, piping, and on board generator.

The vapor is decomposed into water and oxygen by an in-line catalyzer installed on the exhaust line. An H₂O₂ detection sensor measures that no gas residues remain after aeration, permitting door opening at a safe level of less then 1ppm. as an option, additional H₂O₂ detection sensors can be provided for environment monitoring and operator safety.