GxP-Compliant calibration: learning from form 483s and warning letters

In this webinar we briefly outline the practices, processes and regulations governing calibration in GxP-regulated applications. We also analyze several calibration-related Form 483s and Warning Letters issued over the last few years in a range of regulated industries (Drugs, Medical Devices, Nutraceuticals, and Cosmetics).  Each Form 483 and Warning Letter is a cautionary tale for those calibrating instruments and devices for use in federally regulated applications. 

Risk-based requalification

Profile picture for user janice.bennett
Submitted by janice.bennett on
Re-Mapping and Requalification of freezers and refrigerators
Life Science

4 Questions your Risk Analysis Needs to Answer

Our Senior Regulatory Expert Paul Daniel is happy to answer your questions by email. This week’s blog is from an email exchange between Paul and a Senior Validation Manager of a biopharmaceutical firm.

C wrote: Good Afternoon Paul,

I’ve been performing validation for approximately 26 years, but I have a couple questions about requalifying equipment and creating policies for that procedure.  Currently, I’m revising our company procedures for Periodic Review and Requalification. I find that there is a lot of literature to review on requalification for temperature-controlled storage units/areas/stability chambers, etc.

At my former company, we performed mapping annually, which as you know, can be costly and time consuming.  I definitely want go to a risk-based approach for our requalification process, but I need some clarity on assessing risk. At first glance, every temperature-controlled unit and area seems critical and therefore in need of annual requalification.   However, in my research on risk-based analyses for mapping, that seems not necessarily the case. 

We have a continuous monitoring system with its devices calibrated annually.  I’m reviewing all of the initial validations to verify all of the proper testing was performed; that’s intuitively a good first step. My question is – what are my next steps in taking a risk-based approach to requalifying?

Specifically, what types of questions do we need to ask in our risk assessments? 

I believe we can look at trend history, alarm excursions/frequency/length from the continuous monitoring system.  I was also thinking review of the preventative maintenance on the units to check for reliability of things such as motors and door gaskets.  I really want a solid Risk Assessment that is defensible under audit and during inspections.

Can you make any recommendations? 

Sincerely,
C

Paul wrote: Dear C,
 
Happy to help.  Risk assessments are an important tool. Even better, they can, in some circumstances, save resources.

In case you haven't seen it, we have a webinar on the topic here: Risk Assessment in GxP Environments

The most important rule for risk assessments is that the scoring rules are transparent and clear.

The goal with an RA is to make it clear enough so that you feel confident that another person performing a later risk assessment on the same application will come to the same conclusions.  Simply having done a thoughtful risk assessment in the first place will look great to an auditor or inspector – because it is important information about your controlled area(s).

A good place to start is to create scoring rules. For example, what is the main function of the environment? Is it used to store expensive product, or replaceable lab reagents?  Another aspect to look at are the specifications of the environment. Does it have tight control specifications (I.E.: stability chambers)? Or is it a single critical parameter environment (I.E.: -80°C ultra-low freezers)?

Three focal points for scoring risk: 
• What is stored?
• What are the specifications?
• What is the area’s mapping history? 

Regarding the mapping history, I would defer back to a body of knowledge on calibration intervals.  In my experience, there is a surprising lack of knowledge about this in the pharmaceutical industry. But, you actually do not have to calibrate something every year just because the manufacturer recommends it.  If the device is functioning well within its accuracy specifications at every calibration, then that alone can be a risk-based argument for extending a calibration interval. 

We can apply the same logic to chambers – if it maps well and passes every time, perhaps the time between requalification can be extended.   The Application note: “Calibration and Adjustment of Humidity Instruments – Pros and Cons of Different Methods” mentions this on page 1, third column, second paragraph.

Categorizing Applications for Risk Assessment

  1. What is stored in the chamber? For example, are products expensive or cheap? Or, Does the product carry a high risk to a patient if adulterated, or a low risk?
  2. Are the specifications hard to achieve? Like a stability chamber ±2°C and ± 2%RH  or an ultralow freezer at NMT -60°C.
  3. Would a deviation in conditions or equipment failure be immediately obvious and detectable? 
  4. What is the known, documented history of the area or unit, based on past mapping studies?


 
You mentioned the trend history of the unit from monitoring system records. Much can be learned from trend history – as we see in this story from a customer.  However, that can be similar to a single-point mapping while the unit is being opened and used…  And you have to keep repeating this analysis to justify to map or not to map.  Creating rules is a good idea.
Let me know if you have any follow-up questions!

Best regards,
Paul Daniel

C wrote: Thank you Paul. We have another challenge…

We have figured out a periodic review schedule on our temperature-controlled rooms, but now we are trying to determine whether temperature requalification it should be done for 24 or 72 hours (initial studies were 72 hours).

Further, should we map under static or dynamic conditions?  We are leaning toward a 24-hour static full chamber study because we already have a study on 72 hours of empty chamber and loaded static/dynamic conditions.  What we need is simply a verification that everything is still in a qualified state.  I’ve searched high and low on the Internet and there is a lot of information about initial qualification (in all aspects of qualification/validation), but little about performing requalification/revalidation.  We have looked for guidance from WHO, FDA, EU, etc. but there little to nothing. I appreciate your help and look forward to hearing from you.


Sincerely,
C

Paul wrote: Dear C,

Your research echoes my own.  However, one resource I can recommend is the ISPE’s Good Practice Guide for Mapping of Controlled temperature Chambers. 

To summarize the relevant parts of that guide, we should remap every 1 to 5 years. We decide the interval based on history and criticality of the application.

We document our findings and use that information to create a risk assessment. The guide also recommends proposed approach; map in a loaded condition with the same sensor locations. Requalifying loaded areas can save a lot of time and effort!  Your approach is sound especially if there has been no history of malfunctions or repairs on the unit. 

 

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Fighting superbugs proactively: innovation and collaboration in vaporized hydrogen peroxide bio-decontamination

Submitted by janice.bennett on
Portable Hydrogen Peroxide vapor generator for bio-decontamination
Industrial Manufacturing and Processes
Industrial Measurements
Life Science
Finland

In 2014, an independent report commissioned by the UK estimated that drug-resistant infections could result in 10 million deaths and cost over 100 trillion USD by 2050. (See: “Antimicrobial Resistance: Tackling a Crisis for the Health and Wealth of Nations.”) Drug-resistant infections, or so-called “superbugs,” include Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus (VRE), Clostridium difficile (C. difficile), Candia Auris, and other resistant organisms. In response to this emerging issue, the Secretary-General of the United Nations created The Interagency Coordination Group (IACG) on Antimicrobial Resistance in 2016. The IACG supplied its report to the UN in April of 2019, “No time to Wait: Securing the future from Drug-resistant Infections.”

Innovate & collaborate

The report makes five recommendations to combat the threat of Antimicrobial Resistance (AMR), including: “Innovate to Secure the Future” and “Collaborate for more Effective Action.” In Finland, collaboration and innovation to combat drug-resistant pathogens are occurring between the VTT Technical Research Centre of Finland Ltd, Cleamix, a manufacturer of portable hydrogen peroxide vapor generators, and industrial measurement system and sensor manufacturer Vaisala Oyj.

This particular story of innovation begins with the Finnish Air Force seeking a way to destroy biological toxins and weaponized microorganisms. The US military had done a lot of initial work showing that vaporized hydrogen peroxide could be effective as a bio-decontaminant. The problem was that most commercially available H2O2 vapor generators were too large to be field-deployed. So, the Finnish military turned to the scientific community to find a vapor generator that was portable, cost-effective, and capable of sufficient hydrogen peroxide vapor output.

Finnish equipment manufacturer Cleamix was founded to study the problem and created a lightweight vapor generator that could produce sufficient quantities of vapor with the required concentrations of hydrogen peroxide. However, to ensure the vapor would be effective in destroying microorganisms, Cleamix needed their device to specify the right concentration of H2O2 vapor over a given time period. That required a sensor that could measure both the concentration of hydrogen peroxide vapor, as well as other critical process parameters including temperature and a humidity value derived from the combination of water and hydrogen peroxide vapor: Relative Saturation RS%.

 “Whether you are decontaminating a cockpit, ambulance, isolator or operating room (really any area that can be contaminated), you need inline sensors that give values not only for the H2O2 vapor but also for the Relative Saturation, because this will tell you when condensation will occur at the current temperature. Relative saturation indicates the humidity value derived from the combination of water and hydrogen peroxide vapor.” - Panu Wilska, CEO Cleamix

Private enterprise working for public interests

Panu Wilska came to Cleamix in 2016 with over 25 years of international experience ranging from nuclear physics to managing hi-tech start-ups. He has served the company as an advisor, board member, board chair, and now CEO. Cleamix learned that Vaisala was developing a sensor for vaporized hydrogen peroxide and that the sensor would give multiple values; ppm of H2O2 and temperature, but most importantly, a value for the saturation point. Although it is technically possible to calculate values for each parameter - temperature, relative humidity, and ppm H2O2 - you still need a sensor for each.

New technologies combined

Vaisala created the PEROXCAP® technology, and Cleamix was one of the companies that tested the first probes in the series (HPP270). The probes can be used with vapor generators to measure conditions under decontamination; the probes can also be integrated to control the vapor output according to process requirements. Because the Vaisala HPP-series probes enable real-time process control, if the Cleamix vapor generator needs to adjust output to match changing environmental conditions during a process, the probe data allows the generator to adjust automatically.

Cleamix also worked with the military on subsequent testing that was performed at a military research center using vaporized hydrogen peroxide as a biocide in abandoned military buildings to identify required concentration levels of vaporized hydrogen peroxide.  Cleamix initially created two models of portable generators. The larger model weighs only 9.5 kg and can decontaminate areas from ten cubic meters and upwards. Several vapor generators can be networked for large areas, typically using one vaporizer per 100 cubic meters. The smaller model weighs 6 kg and is ideal for areas one to 20 cubic meters, including: cabinets and enclosures, laboratory cabinets, and vehicles, like ambulances and aircraft. Independent tests with the Cleamix units have shown the vapor efficiency ratio (the amount of aqueous hydrogen peroxide that vaporizes) exceeds 90%.

Efficient, effective bio-decontamination

The Cleamix generator uses about one liter of liquid H2O2 for five and a half hours of continuous, full-power operation. With a combination of phase change methods, accelerated vaporization under and over atmospheric pressure, and 3rd party validated efficacy; the company now has 26 patents pending for its unique technology.

Other innovations followed. Along with its portability, the Cleamix vapor generators can vaporize a combination of liquids. Typical applications require a 50% H2O2 aqueous solution, but with the addition of a small amount of ammonia, the vapor can destroy other pathogens, including weaponized nerve gas. The Cleamix H2O2 vapor generators have been independently tested by two different military organizations and found to successfully neutralize all nerve agents, including VX and Sarin. This year saw testing of the Cleamix units in laboratories researching a dangerous new superbug, Candida Auris (C.Auris).

This rapidly emerging fungal pathogen was first discovered in Japan in 2009 and can cause life-threatening infections due to its resistance to all three classes of antifungals. Cleamix’s tests have shown that acetic acid will accelerate decontamination, but C. Auris can also be destroyed with high-concentration vaporized hydrogen peroxide alone.

Emerging threat meets state-of-the-art solution

In April of 2019, the New York Times published an article on C. Auris titled: “A Mysterious Infection, Spanning the Globe in a Climate of Secrecy.” The article describes recent outbreaks in hospitals and medical centers in Spain, the UK, and several states in the US. The Centers for Disease Control and Prevention have added C.Auris to its list of urgent threats. Globally, C.Auris outbreaks have occurred in India, Pakistan, and South Africa. Both the Public Health Agency of Canada (PHAC) and the South African Centre for Opportunistic, Tropical and Hospital Infections (COTHI), released interim recommendations on the management of C. Auris suggesting the use of hydrogen peroxide vapor when feasible, in addition to other decontamination agents and methods. (See: “Candida Auris: Disinfectants and Implications for Infection Control.”)

“C.Auris is highly resistant to many biocides, including vaporized H2O2, but it can effectively be destroyed by H2O2 vapor mixed with other agents. The other liquid used must be more acidic, like Peracetic or Acetic acid. We are involved in more testing with various labs. This is why it was critical that the vaporization method of Cleamix units allowed for combination of liquids.

“Bio-decontamination with vaporized hydrogen peroxide can be used proactively, not reactively. These pathogens are hard to kill and even harder to cure once a person is infected. Frequent bio-decontamination can stop outbreaks, but the equipment needs to be portable, highly efficient, and affordable.” - Panu Wilska, Cleamix

The birth of a parameter

By the time Cleamix began to work with Vaisala, they had already tested other hydrogen peroxide sensors but needed a sensor that was stable, accurate, easy to integrate, and able to provide measurements for all the necessary parameters. “We needed a device that could give a value for the relative saturation of the mixture of water vapor and H2O2 vapor because our original tests used a “dry method” of bio-decontamination that avoided visible condensation,” says Wilska.

Vaisala engineers created a sensor that could measure and control the most important parameters during bio-decontamination: ppm H2O2, humidity, and temperature. This gave rise to a new parameter: Relative Saturation. This parameter helps operators ensure that a process either avoids condensation (dry method vapor decontamination), or includes condensation (wet process). Equipped with Vaisala’s new PEROXCAP® technology in the HPP270 series probes, Cleamix units provide known H2O2 concentration values.  The key process parameters in bio-decontamination are H2O2 ppm concentration, temperature, relative humidity, and exposure time.

H2O2 vapor sensor

In pharmaceutical research, development, and production, bio-decontamination between batches or processes is critical to product quality. In many cases, the same hydrogen peroxide sensing equipment will be used for several different products and processes. Vaisala’s HPP270 series probes provide repeatable measurement, ideal for multiple processes, and are easy to calibrate on-site. Other life science applications that benefit from hydrogen peroxide vapor bio-decontamination include active pharmaceutical ingredient processing, drug compounding pharmacies, and distribution centers.

Today Cleamix delivers their units as standalone vaporizers or as networked modules for larger areas and ventilation systems. Their customers include bio-decontamination service providers, hospitals, military and defense organizations, agriculture and animal laboratories, and pharmaceutical manufacturers.

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Learn more about Cleamix vaporizers at cleamix.com.
Learn more about Vaisala’s solutions for vaporized hydrogen peroxide measurement, monitoring and control.

 

Hydrogen peroxide sensor for biodecontamination

An in-depth look at Vaisala's hydrogen peroxide sensor technology

Read more
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From monitoring to controlling with vaporized hydrogen peroxide sensors:  why, how & a case study

In this webinar, Vaisala’s sensor technology experts welcome two experts from Cleamix Oyj to explain how to integrate Vaisala’s sensors and transmitters and vapor generators to control vaporized hydrogen peroxide bio-decontamination applications.

Cleamix uses Vaisala’s HPP270 sensors to monitor and control the vapor generation with their portable vapor generators - the VCS-100 devices. Two Cleamix representatives will explain the advantages of integrated sensors for monitoring and controlling. Our Cleamix presenters will provide a case study of an effective bio-decontamination of a hospital room.

Two Vaisala sensor experts will also briefly describe Vaisala’s PEROXCAP® sensor technology and its unique ability to measure multiple parameters, including: hydrogen peroxide vapor, temperature, and humidity – as both relative saturation and relative humidity.

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Laboratory monitoring system safeguards HIV/AIDS vaccines

Submitted by janice.bennett on
Laboratory Monitoring, Vaccine Temperatures
Life Science
Brazil

It was winter in the Brazilian state of Rio Grande do Sul when Dr. Leonardo Motta, a research pharmacist, received an email alarm notification while attending a conference in the USA. The alarm came from his lab at the University of Caxias do Sul. The temperature in a fridge storing HIV/AIDS medicines and vaccines had increased beyond storage specifications for the drugs. Motta acted immediately, contacting the lab technicians and letting them know which fridge to check. The technicians quickly found the issue: a frozen unit in the building’s HVAC system. Thanks to the alarm, the lab technicians took corrective action and saved the drugs. The medicines and vaccines inside the fridge were not only valuable, but also critical for the people undergoing treatment at the lab, Instituto de Pesquisas em Saúde (IPS) at University of Caxias do Sul (UCS).

Continuous, flexible and easy to use

Medicines, vaccines and active ingredients for drug manufacturing are sensitive to temperature; their chemical properties can change in different conditions, especially temperature and humidity. A drug or vaccine stored in conditions other than specified for that product must be destroyed. To ensure this does not occur, drugs and vaccines at IPS have been monitored by the Vaisala viewLinc Continuous Monitoring System for the last decade.

“We deployed viewLinc in October 2009,” says Motta. “Originally we installed the system in our ultra-low temperature freezers and a cryogenic freezer. After installing the loggers in freezers, we installed more data loggers in the pharmacy. Later we expanded the system to our refrigerators and to monitor ambient temperature and humidity.”
Dr. Leonardo Motta - University of Caxias do Sul

One feature of the viewLinc monitoring system that has been especially useful at IPS is the software’s dashboard. Dashboards allow a graphic overview of all environments monitored by viewLinc in the facility. Users upload an image file — photo or facility schematic — and add sensors to locations on the image to provide a visual representation of their monitored area. The dashboard interface includes features like color-based status (green, yellow and red) and the ability to click on a monitored location to get historical data and trends from that data logger.

viewLinc customizable dashboard for quick view of monitored locations.
viewLinc's software interface showing customizable dashboards.


Using viewLinc’s secure historical data, lab technicians generated trend-line graphs that indicated a slow temperature increase in an ultra-low freezer. By analyzing the data over time, technicians predicted a possible compressor failure in the freezer. They proactively transferred the specimens to another, more stable ultra-low freezer. Within a week, the freezer that had shown a trend of impending malfunction failed and was decommissioned.

“Our original reasons for choosing viewLinc included remote alarm notification and a wide temperature measurement range. We needed to monitor temperatures in three ultra-low temperature (-70 ° C) freezers and one cryogenic freezer (-150 ° C). Since deploying the system, we’ve made use of many other useful features.

“In addition to graphs and historical data, viewLinc has a Rate of Change (ROC) function that allows us to receive alerts if temperatures vary at a specified rate, for example, 2°C per minute. We also benefit from viewLinc’s automated reports that are delivered according to a schedule we set up. We’ve configured viewLinc’s functions to optimize monitoring according to the needs of each application.”
Dr. Leonardo Motta - University of Caxias do Sul

Automated & compliant

Prior to installing the viewLinc monitoring system, laboratory temperatures were monitored using calibrated thermohygrometer equipment. Lab technicians performed daily temperature checks, manually recording the data.

“This was inadequate for several reasons,” says Motta. “First, it left us without daily data checks and records during weekends and holidays. We would only become aware of any temperature deviation when we checked the monitoring equipment on the next business day.


“Second, the measurement range of the thermohygrometers (-50 °C to + 70 °C) did not permit freezer temperature monitoring to -70 °C. We also needed a system that could send notifications remotely if conditions ever went out-of-specification."

Another benefit to IPS has been viewLinc’s GxP-compliant reporting. “An important part of clinical research is sample storage, which can extend over a long period,” says Motta. “We always have to be able to demonstrate proper sample storage to research sponsors. The viewLinc system not only safeguards our research, but it’s proved very useful during audits or inspections,” says Motta.


In Brazil, the National Health Surveillance Agency (ANVISA) publishes Good Manufacturing Practices that provide guidance monitoring conditions in drug processing and storage. ANVISA regularly audits laboratories, warehouses, manufacturing and processing facilities.

Local support, friendly interface

The viewLinc monitoring system has evolved over time to reflect the newest technology. The viewLinc software interface features on-screen prompts that guide users through common tasks, making the system easy to learn. Embedded help allows end users to install, configure and maintain their system. Additionally, IPS has ensured FDA and ANVISA compliance by validating their monitoring system with viewLinc’s IQOQ documentation. IPS has their data loggers calibrated at Vaisala's Sao Paulo service center.

The ease of use, flexibility and reliability of the viewLinc system are crucial to ensuring IPS’s core mission: “To develop clinical research and provide services in the area of translational medicine, through the generation of knowledge and the pursuit of excellence in health technologies, contributing to the well-being of society.” IPS carries out research through multiple partnerships with universities, governmental organizations, private institutions and national and international funding agencies. Since 2002, IPS has conducted over fifty clinical research projects involving more than 100,000 patients.
 

“Our goal is to ensure that patients have access to new therapeutic regimens, drugs and diagnostic methods without having to wait until they become available through public or private networks. Our laboratory is integrated with the health programs at the University of Caxias do Sul. Through our research into the diagnosis, prevention and treatment of HIV and associated pathologies, we provide life-saving benefits to the community. As our research has evolved, viewLinc has met our needs. We are extremely pleased with the viewLinc system and the services Vaisala provides.”
Dr. Leonardo Motta - University of Caxias do Sul

IPS laboratory staff and Vaisala sales manager at University of Caxias do Sul
IPS laboratory staff and Vaisala sales manager at University of Caxias do Sul.

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On-demand webinar: The viewLinc Continuous Monitoring System with wireless data loggers

Learn more about how the viewLinc system with wireless data loggers can safeguard vaccines and research samples in this webinar:

Wireless Monitoring for GxP & Controlled Environments

Learning objectives:

•What kind of signal ranges are now achievable?
•What wireless features ensure a secure signal?
•What kind of wireless structure is effective?
•What is the infrastructure investment?
•How many data loggers per single network access point?

Watch Recorded Webinar
 

Making Pharmaceuticals 2021

Oct 05
women in laboratory
Ricoh Arena
Coventry
United Kingdom

We will present our reliable and accurate measurement instruments and technologies for measuring humidity, temperature, carbon dioxide, dew point, hydrogen peroxide, differential pressure, continuous monitoring system as well as refractive index t

Forum Labo 2021

Oct 05
Vaisala cleanroom
Hall 3
Paris Expo Porte de Versailles
France

Forum LABO brings together the profession of the laboratory: large, medium and small companies, startups, researchers, students, learned societies but also buyers and laboratory technicians from the public sector or from the pharmaceutical, chemic

Smart Measurement

Make your measurements count

Adding potential for smarter industries

Decisions are only as good as the data

All scientific innovations are based on accurate measurements: to find solutions for our most pressing environmental and societal global challenges, we need verifiable data. Reliable measurements enable Vaisala’s customers make informed decisions and have a positive impact on society by assessing weather and environmental phenomena and by developing more sustainable and efficient industrial processes. 

Industry

Get ready for Industry 5.0

Industry 5.0, is already evolving. It will not be something radically new, but a logical continuum after building the most critical capabilities for smart factories, buildings and processes. Our eGuide will give you an overview on what to expect from Industry 5.0 for understanding the key benefits of the next industrial revolution.

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Drying Simulator

Finding the optimal conditions and being able to keep them stable is the key to lower cost and energy efficient manufacturing. Try out our interactive drying simulator to understand the way exact humidity measurements can lead to more efficient energy use and higher yields.

Interactive Drying Simulator

Calibration made easy for vaporized H2O2 sensors

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Submitted by janice.bennett on
Industrial Manufacturing and Processes
Life Science

The PEROXCAP® sensor for vaporized hydrogen peroxide bases its measurement on two HUMICAP® sensors. To understand how HUMICAP sensors work, it is useful to know a little about thin-film polymer sensors. In this type of sensor, there is a thin layer of polymer between two electrodes. The film absorbs or releases vapor according to humidity changes in the environment.

As the humidity changes, the dielectric properties and capacitance of the sensor changes. A dielectric is an insulator that impedes an electric charge; capacitance is the ability of conductive materials to respond to voltage changes.  Essentially a thin film polymer sensor is measuring voltage changes that occur with the amount of water vapor in the environment. Electronics within the instrument use the capacitance of the sensor to give a humidity measurement.

The PEROXCAP sensor uses two HUMICAP sensors: one with and one without a catalytic layer. The catalytic layer breaks down the hydrogen peroxide so that the HUMICAP sensor with the layer senses only the humidity, while the sensor without the catalytic layer senses both hydrogen peroxide vapor and water vapor in the air. The instrument calculates the difference between the two sensors to give a measurement of H2O2 concentration.


Accuracy & Drift

However, humidity sensors are different from other sensors, such as temperature sensors, because they are in direct contact with the environment they measure. Although the HPP270 series probes provide the highest accuracy and precision, even the best sensors will drift over time. Dirt, chemicals and temperature changes can also cause a drift in accuracy. Regular calibration mitigates incremental sensor drift and ensures instruments are operating within their specifications.


Calibration Options

Factory Calibration:

We recommend H2O2 calibration at a Vaisala laboratory for traceable calibration service. Calibration for the hydrogen peroxide measurement uses two different H2O2 vapor concentrations. Calibrations on the HPP272 probes are performed for H2O2, Relative Saturation, Relative Humidity, Temperature and analog output. Note that the HPP271 probes measure H2O2 only (no temperature or relative humidity calibration needed.) Calibration service comes with a certificate and full instrument maintenance is optional. For factory service, find your nearest calibration center.


On-site Calibration:

For on-site calibrations, we offer a do-it-yourself option with the HMK15 RH calibrator as a reference and our Insight software. The software shows you the drift in both Relative Saturation (RS) and Relative Humidity (RH) and gives you the possibility to make two-point adjustment to these parameters in order to show the same value as a reference value. Based on the humidity calibration, the software also calculates H2O2 ppm error at a certain ppm level. High quality H2O2 measurement performance is also ensured by calibration and adjustment. Learn more about Vaisala calibration service.

 

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On-demand webinar: Calibration vaporized hydrogen peroxide probes

Maintaining quality and consistency is the top priority in life science industries because reliable measurements are key to achieving quality targets. Measurement accuracy and stability are valued features of any sensor used in life science applications. Understanding the sensor behavior over its lifecycle is typically the most challenging task.

Sensor manufacturers can provide  guidelines that are based on typical use, but in vaporized hydrogen peroxide bio-decontamination, each cycle has its own characteristics that will  change over time. Changes in load and equipment wear are two examples that impact processes. The final evaluation of the sensor maintenance activities always falls in the hands of the application specialist. Even though the quality is amongst the top priorities, reality still sets the limits in finding the economical quality optimum.

In this webinar you will learn key considerations for maintaining accuracy HPP270 series vH2O2 sensors. 

Topics:
•    Hydrogen peroxide and relative saturation as measurement parameters
•    Reference measurements in the field and diagnostics
•    Factory calibration

 

 

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