Vaporized hydrogen peroxide is an effective antimicrobial that also destroys fungal spores, bacterial endospores, and viruses. While isolators prevent contamination, to maintain aseptic conditions, vH2O2 bio-decontamination is performed on the internal surfaces of the isolator and the exposed, external surfaces of the materials and equipment placed within. Understanding and controlling process conditions throughout all phases of vH2O2 bio-decontamination is crucial to effective log kills.
To develop an effective bio-decontamination cycle, measurements of process conditions like temperature, humidity, vH2O2 concentration (ppm), and condensation point are necessary. In addition to measuring and monitoring parameters, an understanding of aseptic techniques, glove management, isolator preparation, process indicators, and validation are all important to successful vH2O2 bio-decontamination processes.
In this webinar, Vaisala Product Manager Joni Partanen is joined by Rick Nieskes of Ardien Consulting. Rick brings over thirty years of industry experience to show how to optimize cycle development for vH2O2 bio-decontamination in pharmaceutical isolators. Joni will describe the unique technology of Vaisala's vH2O2 sensor and the importance of calibration and maintenance of these sensors, exposed to the demanding conditions of vH2O2 bio-decontamination.
• Excess vs acceptable condensation of vH2O2
• How to prepare and validate the isolator
• How to adopt a “Quality In = Quality Out” approach
• Achieving consistent critical phase values: Relative saturation, relative humidity, mixture dewpoint, temperature, etc.
• How to find opportunities to decrease sampling with biological, chemical, or enzymatic indicators
• The benefits of monitoring between validations
• Calibration of PEROXCAP® sensor technology vs. Electrochemical cell technology
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Joni Partanen is a Product Manager at Vaisala. He is responsible for the development of humidity and vaporized hydrogen peroxide measuring products. He has over 16 years of experience in process industry measurement technology, industrial engineering, and instrumentation. Joni holds a Bachelor of Engineering degree in Automation Technology.
Founded in 1994 by Rick Nieskes, Ardien Consulting Services (ACS) provides customized bio-decontamination and isolator validation and engineering support services to the pharmaceutical industry. ACS has successfully validated over 150 isolators for production, sterility testing, and containment-based applications at well over 50 different pharmaceutical and medical device companies throughout the world. Prior to founding ACS, Rick worked as a Sterility Testing Biological Quality Assurance Microbiologist at Abbott Laboratories and as a VHP® Sterilization Systems Engineer at AMSCO International (now known as the STERIS® Corporation). Rick holds a BS degree in Bacteriology from the University of Wisconsin - Madison.