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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).
Key Features
- Door GasketDoor gasket made in a single piece of silicone rubber having a “Dove Tail” cross section, pneumatically pressurized by compressed air.
- Maximum SafetyFully 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 SustainabilityOptimized for energy saving and low wastage. Drain cooling system available to cool down all effluents prior to discharge into drains.
- Easy TestingThe front loading side is fitted with connection ports for easy validation testing.
- Easy MaintenanceThe machine is developed considering technicians’ access to the maintenance and service area – easy access to all components conforming to safety regulations.
- 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.
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.
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.
Additional Products
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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.
