World Metrology Day Webinar Series: Measurements for Global Trade 


Calibration and the Making of Medical Devices & Combination Drug Products
Walter Nowocin, Senior Engineering Manager, Metrology & DSR, Medtronic 

Abstract: Calibration plays a critical role in the making of medical devices and combination drug products. In this webinar we will provide the high-level touch points where the U.S. FDA identifies regulatory requirements regarding calibration. We will also review at high-level the important workflows and working environments where and how these products are made; e.g. cleanrooms, packaging, sterilization, and environmental chambers. Various product lines will be used as working examples.

The Critical Role of Pressure Calibration in Clean Room Applications in Regulated Industries
Dallen Baugh, Additel

Abstract: The cleanroom is an essential part of the manufacturing process needed to produce sterile product in highly regulated industries. Cleanrooms must be constantly kept at a higher pressure than their adjacent areas in order to prevent permeation of contaminated air from outside the room. Differential pressure sensors and transmitters are used to monitor and control the cleanroom to the correct positive pressure required. Regular calibrations of these differential pressure sensors is necessary to ensure cleanroom regulatory compliance and ensure a sterile environment. This presentation will discuss challenges and different methods associated with low pressure differential sensor calibrations.

Andy Henson, Bureau International des Poids et Mesures (BIPM)
Opening Presentation for World Metrology Day 2020


Metrology and the Unsung Hero
Dilip Shah, ASQ-MQD

Abstract: We live in a world where we take everyday events surrounding our lives for granted. The alarm clock gets us out of our beds and the hot beverage awakens our mind. The hot shower freshens our body. On the way to work we fill up our vehicles with gasoline at the gas pump or our electric vehicle has been charged at the home station. What if all the clocks were not synchronized and the temperature of the coffee pots and hot water showers were not consistent, the gas pumps did not deliver consistent volume of gas and the electric chargers did not charge the car batteries fully? All of this involves metrology and the people who maintain systems so goods and services produced give us a form of consistency and comfort. This presentation celebrates 2020 World Metrology Day’s theme of Measurements for global trade by looking at how metrology affects our daily lives. Metrology is transparent until something goes wrong and then we realize how important it is and appreciate the folks who work behind the scenes to make our lives comfortable.
Metrological Traceability of Pesticide Testing in Cannabis
Tim Osborne, A2LA WorkPlace Training 
Abstract: Like any agricultural commodity, Cannabis may be attacked by pests or pathogens and may require treatment with insecticides, acaricides, fungicides, and potentially other crop protection agents (CPAs). Even if none are applied the crop may be grown in soils contaminated by organic chemicals from earlier agricultural operations, exposed to spray drift from adjacent fields, or even take up toxic metals from the soil. Fortunately, many of these types of potential contamination are known in other crops, where tolerance levels are established and monitored through health risk analysis of to assure the safety of vegetable and meat products and beverages. The same approach is used with Cannabis, however there are issues: 1) extrapolation from levels deemed safe for ingestion to inhalation in humans is not always straight forward, 2) cannabis is an extremely complex plant that contains a large variety of chemical compounds, analyzing the cannabis matrix where some of the pesticides may coelute with the measured can make detection and accurate quantification of trace levels of pesticides more challenging. 3) Cannabis is federally illegal so there is no one set tolerances that exist for residue levels on cannabis. Legally defensible analysis depends on traceability; this makes ISO/IEC 17025 accreditation of the laboratory a valuable tool as it helps to set appropriate quality technical requirements to be met for use of a product not well-researched. ISO/IEC 17025 generally requires the use of validated methods, proficiency testing and certified materials. Despite the availability of both ISO 17034-2016 certified and non-certified pesticide reference materials few are sold in a matrix. When there is not a ISO 17034-2016 pesticide infused matrix material available for use as calibrators but a primary reference method is, then there can be a reasonable traceability to the SI, according to the calibration hierarchies addressed in ISO 17511. These meteorological relationships are discussed in the presentation.

Advances with Quantum Hall Effect Resistance Standards
Alireza Panna, NIST
Abstract: Epitaxial graphene based quantized Hall standards have simplified the efforts needed to realize the ohm at the National Institute of Standards and Technology. After giving a brief introduction on the advantages of using epitaxial graphene to realize the ohm rather than traditional GaAs heterostructure based quantized Hall standards, this talk will summarize the recent progress made to realize and advance the ohm through the quantum Hall effect in the following ways: 1) demonstration of a quantum Hall effect Kelvin bridge on a chip to characterize resistance standards 2) realization of a 1 kΩ epitaxial graphene based quantum Hall array resistance standard, and 3) investigation of the quantum anomalous Hall effect as a candidate for next generation quantum Hall standards.

MEET THE PRESENTERS


Dallen Baugh has been working in the metrology community for 24 years. Dallen has an Electrical Engineering degree from Weber State University and an MBA from the University of Phoenix. Dallen spent 14 years with Hart Scientific/Fluke where he was the US Sales Manager, 4 years with ThermoWorks as the Sales Manager, and is currently the VP of Sales for Additel Corporation. Dallen has a diverse knowledge of temperature metrology as well as pressure. He has worked with top level labs around the world, including NIST US, NIM China, NIM Japan, NIM Thailand, NRC Canada, PTB Germany, LNE France, NPL United Kingdom, MSL New Zealand, as well as top level private labs around the world. Dallen and his wife Katherine have 3 children and 4 grandchildren. He loves the outdoors including hunting, fishing, and motorsports.

Andy Henson is an Honors graduate in Mechanical Engineering and a Chartered Engineer. He is currently the Director of the International Liaison and Communication Department for the intergovernmental Bureau International des Poids et Mesures (BIPM), based near Paris. In addition to his liaison role, Andy has responsibility for the operation of the CIPM MRA, the BIPM publications, including Metrologia, and the BIPM website. He also leads the BIPM capacity building and knowledge transfer (CBKT) programme. Andy was formerly Director of International Projects at the National Physical Laboratory (NPL) in the UK where he was instrumental in establishing and leading the European Metrology Research Program (EMRP) initiative for EURAMET. Prior to this appointment Andy completed a three year spell managing research in the Measurement & Testing Unit of the European Commission. His early career was in marine engineering and certification of conventional nuclear power plant. Andy also spent a number of years at the Joint European Torus thermonuclear fusion research project. He is Fellow of the Institute of Physics, and was awarded an MBE in the 2008 Queen’s Birthday Honors for “Services to Measurement Science.”

Walter Nowocin has 30 years of experience in the field of metrology with Medtronic as a Senior Engineering Manager, and with the United States Marine Corps as a technician, technical instructor, and lab manager. Walter is a Member Delegate to NCSLI representing Medtronic, a member of the NCSLI Twin Cities Steering Committee, and the Chair of the NCSLI Healthcare Metrology Committee. Walter has a Masters in Engineering Management degree from St. Cloud State University, St. Cloud, Minnesota and is an Adjunct Instructor with St. Cloud State for the Engineering Management graduate program teaching Management of Technology and Innovation. Walter is an ASEM Certified Professional Engineering Manager (PEM).

Tim Osborne serves as VP of Training Services at A2LA WorkPlace Training. Most recently, he was the Director of Quality for Trescal, Inc., where he developed, oversaw and participated in the training program which included courses on management systems, system processes, measurements and data analysis tools. While at Trescal, he served as A2LA’s Criteria Council Chair and Measurement Advisory Committee Chair. Currently, Tim was the VP of Operations for NCSL International and VP of Standards and Practices for NCSLI and the Chair of the ASC Z540 Committee. He participated in and oversaw the development of the ANSI/NCSL Z540.3 Handbook and several Recommended Practices. Tim has a bachelor’s degree in Nuclear Engineering with a minor in Materials Engineering and Chemistry.

Alireza Panna was born in Mumbai, India. He received the B.S. degree in Electrical Engineering from the University of Maryland, College Park, MD, in 2013. From 2012 to 2013 he worked as a guest researcher for the National Institutes of Standards and Technology, Gaithersburg, MD, where he was involved in the magnet characterization for the NIST-4 Kibble balance. From 2013 to 2017 he was with the National Institute of Health, Bethesda, MD, where he worked on controls and characterization of various x-ray imaging modalities. He is currently with the National Institute of Standards and Technology where he is involved in the Metrology of the Ohm and the Quantum Conductance Projects.

Dilip Shah has over 45 years of industry experience in metrology, electronics, instrumentation, measurement and computer applications of statistics in the Quality Assurance areas. He has been employed in various positions with Philips Electronics (UK), Kodak Ltd. (UK), Instruments Division of Monsanto Corporation, Flexsys America and Alpha Technologies. He is currently a Principal of E = mc3 Solutions, a consulting practice that provides training and consulting solutions in ISO/IEC 17025, Measurement Uncertainty and computer applications. Dilip is the co-author of The Metrology Handbook (1st and 2nd editions) published by the ASQ Quality Press. Dilip participated in the initial development of ASQ’s Certified Calibration Technician exam. Dilip is an ASQ Fellow and a member of IEEE. Dilip has served as a Member of the A2LA Board of Directors (2006-2014). Dilip is a Chief Technical Officer for Sapphire Proficiency Testing which provides many measurement-related proficiency testing options to the industry. Besides being an A2LA Trainer, Dilip served as the NCSLI Conference Tutorial Program Chair (2012 - 2017), is a frequent contributor to the ASQ Quality Progress Magazine’s Measure for Measure column and ASQ Expert Answers Blog Contributor.