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
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 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 H2O2 and delivers it to the vapouriser 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.
Fast and Safe Areation Phase
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 than 1ppm. As an option, additional H2O2 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
Our 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.
Door gasket made in a single piece of silicone rubber having a “Dove Tail” cross section, pneumatically pressurized by compressed air.
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.
Optimised for energy saving and low wastage. Drain cooling system available to cool down all effluents prior to discharge into drains.
The front loading side is fitted with connection ports for easy validation testing.
The machine is developed considering technicians’ access to the maintenance and service area – easy access to all components conforming to safety regulations.
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.
Remote FAT service
In order to support the equipment verification procedures for our clients, we then introduce an alternative way to perform FAT – Factory Acceptance Testing, usually realized onsite. Remote FAT is a smart cloud-based service to support customers step by step in all procedures and testing and the production of related documentation that can be executed remotely, reducing the time required for staff to be away from the office and the associated costs including travel, accommodation, visa application, etc.
Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
- GAMP 5
- FDA Regulation 21 CFR Part 11, 211, 820
- ASME BPE
- PDA Technical Report
- European and US Pharmacopeia
- ISPE Guidelines
- UL and CSA (on demand)
from 195 litres / 7 cu ft
to 10.000 litres / 353 cu ft
Custom dimensions are available upon request.
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.
Biotechnology and Vaccine Production
Clean and sterile equipment used in Bio-Pharmaceutical production processes helps avoiding the risk of batch contamination and failure. Steelco offers devices to properly decontaminate both equipment and single use items.