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DHP Series Decontamination Air Locks with VH2O2
The DHP Series of 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).
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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 436 litres / 15 cu ft
to 7.875 litres / 278 cu ft
Custom dimensions are available upon request.
Overall dimensions
The overall dimensions may vary according to machine configuration and customer requirements. The electrical cabinet may be installed remotely from the machine.
The onboard generator prepares the correct dose 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 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.
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.
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.
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.
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.
Autres produits
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Sterile continuity is the vision. The SPE Series is ideal for treating closures for containers normally used in the pharmaceutical industry, where continuous sterility has to be maintained between different phases.
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.