H₂O₂ Sterilization Monitoring & Automation

H₂O₂ sterilization for rooms

The challenges that face staff when sterilizing large areas may not always seem obvious. The need to monitor and record RH/T within a laboratory is fairly typical in order for labs to meet regulatory compliance requirements, but with many using a VHP method of sterilization the challenge comes with maintaining a consistent record of data during this process. Find out how Hanwell solutions can overcome all obstacles using unique methods below.

Products that make up this solution

Vaporized Hydrogen Peroxide Automation

Overview

Disinfection of pharmaceutical environments including cleanrooms and production lines is required at various times throughout the year. There are many methods used to do this, but Vaporized Hydrogen Peroxide (VHP) is often a preferred option. VHP is also an alternative to chemical fogging for the food industry.

What’s the process of VHP?

The process involves liquid H₂O₂ conversion to a vapor and the vapour filling the required laboratory, contacting and sterilizing exposed (usually fixed) surfaces.

Once the H₂O₂ sterilization cycle has completed, the vapor is vacuumed from the chamber and converted to water and oxygen.

To ensure the effectiveness of the process it’s vital that accurate and reliable temperature and humidity data is available.

What are the challenges of VHP within labs?

The challenges that face staff may not always seem obvious. The need to monitor and record RH/T within a laboratory is fairly typical in order for labs to meet regulatory compliance requirements, but with many using a VHP method of sterilization the challenge comes with maintaining a consistent record of data during this process.

Most RH/T wireless data loggers are unable to withstand the process and need to be removed causing potential gaps in RH/T records. Alternative loggers can be used to bridge the gap, but it adds cost and time to create a clunky solution.

Environmental Monitoring – Standard Validation System

synergy-softwareThe Hanwell Pro FDA 21 CFR Part 11 compliant and validated system monitors the ambient RH/T throughout the entire laboratory 24/7. The unrivaled Hanwell radio telemetry is able to easily pass through multiple rooms and even floors to reach office based SR2 network receiver. From here staff can access data, reports, audit trails and more from multi-user licences.

The user permissions set up by the Laboratory administrator means users can have access to specific zones, sensor groups or a customized category of their choice.

As RH/T is elevated prior to commencement of the treatment the need for continuous monitoring before, during and after the process is crucial. The Hanwell RL5000 with special poly carbonate casing and H₂O₂ resistant RH/T sensors, means the data is transmitted 24/7 and can remain in situ while H₂O₂ sterilization commences, providing continuous close-loop verified monitoring.

Environmental Control – During VHP

Hanwell take it one step further by using the same RHT data to trigger the H₂O₂ sterilization equipment automatically.

What makes the Hanwell system unique is the ability to put another radio receiver (CR2) in a different location, this receiver has a Modbus output that sends data directly to the H₂O₂ sterilization control system.

The significance of this addition is that the RH/T data from a single source is recorded in a compliant validated system and the same data is used to control the process.  This method proves and verifies that the correct conditions were achieved during treatment.

The ability to automate the process without removal of the RH/T sensors saves time and money and removes uncertainty.

How it works:

Sample report

Below is an example graph for RH/T graphs generated by Hanwell EMS:

Sample RHT report

Looking for data loggers to monitor chambers?

Chamber sterilization with H₂O₂ is a low-pressure, low-temperature, nontoxic process with temperatures typically between 6 °C and 60 °C that uses vaporized Hydrogen Peroxide to reduce the level of infectious agents. Ellab data loggers provide high precision solutions for these applications. Find out more here.

ISO Therapeutics - Case Study

Pharmaceutical Temperature Monitoring – ISOTherapeutics

ISOTherapeutics swapped standalone data loggers for wireless pharmaceutical temperature monitoring.

Read more
Pharmaceutical Temperature Monitoring