Meeting the Needs of the Sterilization Industry – Safely and Effectively

Medical issues that are arising from the COVID-19 pandemic have put sterilization technology at the forefront of the battle. Although many technologies are being considered to help sterilize and disinfect various health and medical items, vaporized hydrogen peroxide (VHP) is one of the few sterilization methods that is effective for virus deactivation and microbial reduction. To sterilize large amounts of products quickly and economically Vaporized Hydrogen Peroxide (VHP) Sterilization Isolators have been an effective proven option for over a decade.

VHP Room Bio-decontamination Isolator Advantages:

  • Compatible with many types of material, including sensitive electrical equipment and heat-sensitive parts
  • Rapid cycle and turnaround time
  • Adaptable and easily controlled process
  • Process is easily validated to meet user needs
  • No organic residue, oxygen, and water are the only by-products
  • More efficient and takes less time to process than heat microbial reduction (HMR)
  • Personnel safety and health issues are minimized because of containment
  • May be used in conjunction with various cleaning agents

Global leaders in the sterilization industry have selected and successfully implemented the Guided Wave Hydrogen Peroxide Vapor (HPV) Analyzer on numerous products due to the real-time, repeatable performance. The system can be utilized to:

•  Verify isolation chambers have proper HPV coverage
•  Ensure porous packaged products inside the chambers receive proper HPV dose
•  Confirm other monitors provide correct HPV data and result

As the industry quickly adapts and creates new products to meet this healthcare crisis, this proven and accepted technology can reduce the time to market and ensure safe, reliable results.

As stated in the Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff, “ the FDA does not intend to object to limited modifications to the indications or functionality of FDA-cleared or FDA-approved sterilizers1

Nevertheless, it is important to make sure that the on-board measurement system is industry-recognized to ensure that reliable results and industry standards are met to such essential sterilization requirements. The power of NIR online process monitoring, along with Guided Wave’s HVP Analyzer systems, are well-equipped to help the marketplace meet the current and future sterilization challenges.

Guided Wave’s Hydrogen Peroxide Analyzer simultaneously measures vaporized hydrogen peroxide and water vapor. By measuring VHP and water vapor continuously, these concentrations can be measured over time during the isolator decontamination cycle and used to determine reaction kinetics. Readings gathered from the HPV Analyzer can ensure that the isolator and sterilant kill load have similar vapor concentration profiles from run to run3.

Guided Wave’s HPV Analyzer is the preferred technology to validate sterilization isolators and whole room bio safety lab sterilization and virus deactivation.

Footnotes:

1 Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff, March 2020 https://www.fda.gov/media/136533/download

2 Environmental Control in Biological  Production rooms utilizing Vaporized  Hydrogen Peroxide (VHP®) and Ultra-violet Biodecontamination Applications; Steris Life Sciences Case Study 7, 2004 Download

3 Comparing and Contrasting Barrier Isolator Decontamination Systems Jim Fisher and Ross A. Caputo*, Pharmaceutical Technology, www.pharma.com, Nov 2004

Posted in Guided Wave News.