DHP Series Decontamination Air Locks with VH2O2

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.