Brent Lloyd, RN
Founder and President of Invisible to Visible Disruptive Technologies
In July, the U.S. Food and Drug Administration adopted an international sterilization standard to give medical device manufacturers another alternative to ethylene oxide (EtO). Manufacturers can now make declarations of conformity to the International Organization for Standardization’s recommendations on low-temperature vaporized hydrogen peroxide in submissions to the FDA.
So, let’s take a look at Hydrogen Peroxide Vapor (HPV) technology as a safe, effective alternative and two products that reduce labor, streamline operations and maintain material cleanliness. I’m talking about the M2DCON Family of Gaseous Decontamination Systems that bring consistency, affordability, and reliability to cleanroom spaces.
M2DCON is a leader in dry hydrogen peroxide vapor (HPV) technology. HPV is growing as a highly validated method for decontamination and sterilization in industries such as healthcare, pharmaceuticals, and biotechnology. Its effectiveness relies on proper application, appropriate concentrations, and thorough understanding of the specific situation in which it’s being used. The M2DCON’s SafePass GDSTM and Transport GDSTM make the process simple and are ideal for operations requiring rapid and effective bioburden reduction on materials entering clean spaces.
The M2DCON family of Gaseous Decontamination Systems (GDS) uses HPV technology, and incorporates rapid cycle time, a high level of reliability, minimal maintenance, and a user-friendly interface. Its Proprietary CoolFlowTM technology provides dry, non-condensing HPV capable of meeting the stringent temperature requirements for items being decontaminated.
HPV is generated by vaporizing a concentrated solution of hydrogen peroxide, typically around 30-35% concentration. This vaporization process creates a highly reactive environment, as hydrogen peroxide is known for its oxidizing properties.
In sterilization applications, HPV is often used due to its effectiveness in killing a wide range of microorganisms, including bacteria, viruses, and fungi. The vapor can penetrate hard-to-reach areas and provide thorough disinfection without leaving residue. It is commonly used in pharmaceutical, biotech, healthcare, and other industries where high levels of sterility are required.
Claims that hydrogen peroxide vapor is not effective are mostly related to the practical application of HPV. These include environmental factors and incorrect application.
Environmental Factors: Temperature and humidity are environmental factors that can influence the HPV decontamination process. HPV is generated by heating a liquid solution of hydrogen peroxide, typically around 30-35%. During the heating process, both hydrogen peroxide and water are vaporized at a relatively equal rate and are released into the environment. Warmer air can hold more peroxide and water, up until a point at which the air becomes saturated, and condensation occurs. If the starting air is already humid, then the air will reach this saturation point sooner. Uncontrolled condensation reduces the available HPV that would be distributed throughout the space, which can also lead to surface damage of certain materials where the condensation occurs. M2DCON’s Proprietary CoolFlowTM technology provides dry, non-condensing HPV to prevent condensation and material damage, while providing the desired decontamination efficacy for the customer.
Incorrect Application: Improper application, including errors in pre-cleaning and equipment setup can lead to reduced decontamination effectiveness. With HPV, like any decontamination process, it is critical to ensure the equipment is operating correctly and that the manufacturer’s instructions for application are followed, including all safety precautions. Incorrect use of equipment may lead to ineffective vaporization, insufficient HPV distribution, low HPV concentration or reduced exposure (contact) time. Simply forgetting to turn on a fan used to aid HPV distribution can lead to incomplete decontamination. With M2DCON’s family of GDS systems, integrated blowers and fans provide effective HPV distribution and mixing within the chamber space, and an integrated HPV sensor ensures effective concentrations are maintained throughout the decontamination time.
Finally, microorganisms are often co-located with various types of soil in the environment, which can act to protect or shield the microorganism from the HPV. Removal of visible soil and pre-cleaning materials are critical steps for any effective decontamination process. Treatment of a soiled surface may result in decreased effectiveness as the soil can inactivate or catalyze the breakdown of the HPV before it has a chance to interact with the bioburden.
Further, not all soils are created equal; some may be more effective at breaking down hydrogen peroxide into water and oxygen. M2DCON’s family of GDS systems are designed with material process and flexibility in mind, so that operations can integrate efficient and effective material handling into their work stream and reduce the introduction of soils before the decontamination process occurs.
With this knowledge of its ease of use, effectiveness, reliability and approval by the US Food and Drug Administration, M2DCON’s GDS systems are definitely worth serious consideration in cleanroom environments.
