Hydrogen Peroxide Sterilant Vapor Monitoring

Hydrogen Peroxide Sterilant Vapor Monitoring refers to the process of detecting and measuring the concentration of hydrogen peroxide (H₂O₂) vapor used during sterilization processes, especially in environments like pharmaceutical manufacturing, medical device production, and cleanrooms. Our GUIDED WAVE™ ClearView® Hydrogen Peroxide Vapor Analyzer System is a simple turnkey solution for the measurement of hydrogen peroxide and water (H₂O₂ and H₂O) concentrations in vapor phase

What is special about near-infrared (NIR) light?

NIR light helps monitor sterilant’s molecular vibrations using their specific light absorptions. As a result, using NIR optical methods, fast and direct chemical measurements are made without the need for indirect sensors, wet chemical methods, or other time-consuming procedures.

Why monitor sterilant vapor concentrations with NIR Spectroscopy?

Near-infrared spectroscopy provides a sterilization monitoring solution that operates in a positive and negative atmosphere. Because NIR spectroscopy uses light to monitor the chemical concentrations, the Vaporized Hydrogen Peroxide Analyzer can monitor sterilant levels under non-condensing conditions. The number of sterilant and moisture molecules in the NIR optical beam causes the measurement signal.

What other technologies are used for sterilization monitoring?

Electrochemical sensors are also used for sterilization monitoring. During the 1990s, the use of H₂O₂ as a sterilant occurred mainly in atmospheric isolators. Electrochemical sensors worked well for this type of vapor measurement. These devices were a good choice at a lower price point because the robust measurement advantages of NIR spectroscopy were not necessary. However, electrochemical sensors cannot operate in a vacuum and can also be damaged or poisoned by high sterilant concentrations.

What changes have you seen in the market for sterilization measurements?

The need for low-temperature sterilization for medical devices and other challenging substances has increased in the last two decades. The development of vacuum chambers to enhance sterilant drive into packaging and product surfaces followed. However, popular for atmospheric isolators, electrochemical sensors do not work in a vacuum or in atmospheres where pressure changes. Most electrochemical sensors also do not measure moisture.

How has the NIR Sterilant Analyzer evolved to meet these changing market demands since its introduction over 25 years ago?

The original HPVM was a unique fiber-optic-array spectrometer for superior direct sterilant measurement. This complete NIR analytical system comprised three main components:

The NIR spectrometer
A pair of fiber optic cables for each probe
The sample interface, in this case, the G-SST vapor probe.

The spectrometer transmits the source light and quantifies the sterilant vapor-modified light, while the specialized fiber optic cables enable localized vapor probe placement. Longer fiber optic cables have also been used for monitoring a network of biosafety environments for decontamination.

Our GUIDED WAVE™ ClearView® Hydrogen Peroxide Vapor Analyzer System is a simple turnkey solution for the measurement of hydrogen peroxide and water (H₂O₂ and H₂O) concentrations in vapor phase. These are both measured together because they are codependent. The analyzer operates in real time, which takes the guesswork out of determining the H₂O₂ and H₂O concentrations during cycle development and throughout the actual sterilization cycle. The user gains continuous, accurate data for documentation and validation.

The next-generation HPV Analyzer includes a dual-beam, multiwavelength NIR photometer with two independent sampling points. The design enables factory wavelength changes, so other sterilant vapors, such as ethylene and nitrous oxide, are also monitored. The dual-channel systems are particularly useful for R&D, cycle development, diagnostics, and differential process monitoring.

The HPV Analyzer is the best choice for end users who need a vapor probe placed at various locations within a chamber. The redesigns of the remote vapor probe have improved durability under changing vacuum conditions. The HPV ClearView db filter photometer and remote vapor probe will continue to be commercially available.

Process Insights_Guided Wave Hydrogen Peroxide Vapor Analyzer HPVA Photometer Systems

Measuring H₂O₂and H₂O Under Ambient or Vacuum Conditions – Ideal
for Low Pressure Monitoring

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FAQs HPV Analyzer System

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Is the LED-HPV Analyzer used for control purposes or point monitoring?

Our GUIDED WAVE LED-HPV Analyzer can be used for monitoring and control purposes. New Forge Technologies delivers sterilization process control using NIR in its Bier Resistometer.

Dr. Matt Schurman and his team of engineers and scientists found the ISO protocol was not being rigorously implemented for instantaneous burst exposure to HPV Sterilant Vapor. The Bier Resistometer is a biological (BI) and chemical (CI) Test and Standards Chamber.

New Forge developed an innovative Bier Resistometer with a built-in HPV Analyzer for controlling sterilant injection and providing precise and instantaneous HPV exposure. The process diagram below illustrates how New Forge achieves precise HPV concentration for a standardized sterilant exposure for (BI) and (CI) indicator strips.

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How does New LED-HPV Analyzer complement rapid biological indicators?

Biological indicators (BI) have been the final go/no go of sterilization validation testing. By placing biological indicators in the sterilization chamber with the load (product to be sterilized), technicians can verify that a kill dose of sterilant was received to regulatory standards. However, BIs require time to develop an answer, and the load is quarantined during this period. The LED-HPV Analyzer was developed to complement and advance release testing technology. A basis for better control of the sterilant concentration is emerging by providing real-time monitoring.

In the past, if a biological indicator showed that a kill dose was not received, the data produced by the Hydrogen Peroxide Vapor Analyzer could be used to help explain what went wrong with the sterilization cycle. By combining biological indicators with NIR, engineers designing the next generation of pallet-to-tabletop-sized sterilizers can reduce the time to market for new products. New ambitious regulatory goals for automated release testing call for the sterilization chambers to have real-time process chemical load validation.

Does the LED-HPV measure anything other than H₂O₂ and H₂O vapor concentration?

The LED-HPV Analyzer includes an RTD temperature sensor. This enables the direct calculation of Relative Humidity (RH) and Relative Saturation (RS) inside the chamber. The ability to independently calculate relative saturation, in addition to hydrogen peroxide and relative humidity, enables improved process control and exposure times while avoiding condensation inside the chamber.

The data is output over RS232 or RS485 to a PLC or other data logger. With a minimum scan speed of one second, the LED-HPV Analyzer provides real-time data for process control. With the addition of a sanitary fitting, the sample interface can be mounted in any sterilization chamber or isolator with an available >50 mm diameter port.

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Hydrogen Peroxide Sterilant Vapor Monitoring