Decontamination Air Locks with VH2O2
The DHP Series of pharma-grade decontamination air lock is manufactured to provide 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.
The Steelco DHP series is available in single or double doors versions with hinged door(s) in stainless steel with glass windows. To ensure perfect tightness for safety, the unit is provided with double inflatable gaskets. Flexibility and versatility characterize the series devices available in several models and different chamber capacities – with a chamber volume ranging from 436 to 7875 liters (15 to 278 cu ft).
The vaporization process of the liquid hydrogen peroxide is performed through an onboard generator fully integrated into the technical area of the main equipment. A ventilation system guarantees a uniform VH2O2 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.
The DHP Series of pharmaceutical-grade decontamination airlock is designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customers’ compliance with current Good Manufacturing Practices (cGMPs).
Precise H2O2 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 fascia 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.
Reliable and Hygienic Construction
The materials used in the construction of the Decontamination chamber and piping are only Stainless Steel, Glass, and other FDA-approved certified polymers that are compatible with the sterilant used. As standard, chamber and internal door parts are made of AISI 316L stainless steel, mechanically polished with no seams or joints. Chamber designed with an inner lateral air duct that allows a uniform recirculation airflow around the chamber and load.
Door Double Inflatable Gaskets
The double inflatable gaskets are separately controlled to give total tightness safety even in the event of failure of one of the seals. An air reservoir provides additional protection by maintaining the gasket pressure in power failure or loss of compressed air pressure. A barrier and interlocking door system ensure the separation of different grades of a clean environment.
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.
Integrated Automation Architectures
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.
Smart Load Cell
Load cell with draft pipe and adaptable cap for any H2O2 canister available on the market.
Recirculation internal fan designed to reduce the aeration time of the chamber, assuring high-speed airflow and higher throughput.
Door Interlocking System
An interlocking system assures the separation of environments at different contamination levels, allowing installation in a barrier.
Fully designed with operators’ and instruments’ safety in mind. In addition, two test points ensure that no gas residues are still present and that the aeration has been adequately carried out.
The machine is developed considering technicians’ access to the maintenance and service area – easy access to all components conforming to safety regulations.
The onboard 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.
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 436 litres / 15 cu ft
to 7.875 litres / 278 cu ft
Custom dimensions are available upon request.
The overall dimensions may vary according to machine configuration and customer requirements. The electrical cabinet may be installed remotely from the machine.
Formulation, Fill, and Finish
The industry’s widest portfolio of cleaning and sterilization equipment for sterile drug production.
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.