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).
Effective decontamination cycle of pharma steam sterilizer
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 H202 distribution in the chamber and on the load, assuring a fast aeration phase and higher throughput. Following this low-temperature treatment, the decontamination reaches the sterility assurance level (SAL) values up to 10-6.
Precise H202 dosing system
The onboard generator prepares the correct dose of H202 and delivers it to the vapouriser system. The Liquid H202 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 H202 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.
Fast and safe areation phase
Once the bio-decontamination process is complete, to reduce the concentration of H202 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 H202 detection sensor measures that no gas residues remain after aeration, permitting door opening at a safe level of less than 1ppm. As an option, additional H202 detection sensors can be provided for environment monitoring and operator safety.
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 complete 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 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.
Quality engineering process and qualification services
Steelco equipment's technical consulting, design, engineering, project management, and commissioning and qualification services are offered, with customers appreciating the cost-effective, high-performance solutions provided to resolve complex washing and sterilization challenges. Design qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are provided in a 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.
