The first and the third article in this series focused on manually operated pipettes as sources of error, caused either by mechanical failures¹ or induced by poor operator technique².Thorough training of pipette operators, combined with regular calibration and verification cycles to monitor the mechanical performance of pipettes are essential to prevent costly errors to any laboratory or institution. Properly devised Standard Operating Procedures (SOPs) can minimize such error sources to a large extent.
Whenever experimental results deviate from the anticipated results, it is common to examine the reagents, experimental protocol, instruments, and even the researcher’s technique for potential sources of the error. Often, the root cause can be identified this way, and subsequently be eliminated.
In light of the multitude of error sources, it is easy to overlook the environmental conditions in the laboratory, and the effects they can exert on the quantitative dispensing of liquid with handheld pipettes. This article will focus on only two of these variables: barometric pressure and thermal disequilibrium between reagents and pipettes.
To understand how these environmental conditions affect the performance and operation of air-displacement pipettes, one has to understand the way these instruments operate and how they are calibrated by their manufacturers.
In mechanically operated air-displacement pipettes, a piston moves inside the pipette shaft, increasing or decreasing the air volume inside of the shaft. The air cushion, which is created inside of the pipette shaft once the pipette tip is immersed in the sample liquid, couples the piston to the liquid and affects the aspiration of the sample into the pipette tip. This mechanism allows the sample to contact only the disposable tip, thus allowing the rapid successive use of the pipette with different samples by simply changing tips.
The construction and operating principle, however, render these pipettes susceptible to variations in barometric pressure, temperature, and humidity.
This susceptibility of pipetted volumes to environmental influences is recognized in international pipette standards such as ISO 8655-2, which stipulates that pipettes must be adjusted to deliver correctly at 101 kPa barometric pressure (sea level), 50% relative humidity, and 20 °C. Furthermore, the related part six of this standard (ISO 8655-6) requires that equipment (pipette and tips) be brought into thermal equilibrium with the sample solutions by waiting at least two hours prior to performing calibration testing.
These tightly specified conditions can be met in carefully controlled calibration laboratories. The vast majority of scientists, however, often use air displacement pipettes under conditions that differ significantly from these calibration specifications.
Some liquid delivery instruments use positive-displacement rather than air-displacement. In these devices, including syringes, certain handheld pipettes and some automated liquid handlers, the piston is in direct contact with the sample to be dispensed. While these devices are largely unaffected by changes in environmental conditions, tedious cleaning procedures and the increased danger of cross-contamination are two disadvantages limiting widespread use.
In most cases, pipettes are calibrated by their manufacturers in laboratories that operate at barometric pressures that correspond to near sea-level altitude. Many laboratories, however, are located at altitudes that are significantly above sea level. As elevation increases, barometric pressure decreases.
The scientists at Artel investigated the impact that changes in barometric pressure exert on the accuracy of pipetted volumes. A set of fixed-volume pipettes and a set of adjustable-volume pipettes, all from leading manufacturers, were tested at an altitude of 6,288 feet (over 1900 m), on top of Mount Washington in New Hampshire. The results obtained at this elevation were compared to the volumes measured in Artel’s accredited laboratory (ISO 17025) under controlled conditions at sea level in coastal Maine. The same pipettes were operated by the same technicians to minimize operator variability.
To ensure a scientifically sound comparison of the data, Artel determined the accuracy and precision of the pipettes with the PCS® Pipette Calibration System. Unaffected by differences in barometric pressure, the PCS acquires NIST-traceable data, based on the principle of ratiometric photometry, regardless of where the data collection takes place.
The dispensing accuracy of three fixed-volume micro-pipettes of commonly used volumes (200 μL, 10 μL, and 1 μL) were evaluated by two scientists who were trained and certified using the Artel Method™ (a comprehensive, science-based training suite for standardizing and optimizing pipetting skills). The data presented in Table 1 show that all of the pipettes under-delivered at high altitude, compared to the sea-level laboratory data. Figure 2 shows the under-delivery of the pipettes, after normalizing it to the laboratory data. It is evident that smaller volumes are more affected by the influence of reduced barometric pressure: the 1 μL pipette consistently under-delivered by 9%, while the 200 μL pipette under-delivered only by 1.3%. The data also demonstrate that the variation between both trained and certified operators is minimal.
The liquid delivery of three adjustable-volume pipettes (20 μL, 10 μL, and 2 μL) was investigated at their nominal volume, as well as at 10% of their nominal volume. The data for both conditions, high altitude and sea level, is summarized in Table 2, and the normalized high-altitude data are shown in Figure 2. All tested pipettes under-delivered at both volume settings when used in reduced barometric pressure. Concurrent with the fixed-volume pipettes, the results show that smaller volumes are more affected by the change in pressure than are larger volumes: while the 2 μL pipette under-delivered by 4.3% at its nominal volume, the 20 μL pipette exhibited under-delivery of less than one percent. Induced inaccuracies were found to be significantly larger when the pipettes were used at 10% of their nominal volume, with errors ranging from 3% to over 30% under-delivery.
Volume control samples were dispensed via calibrated glass syringes (200 μL, 40 μL, and 8 μL), which operate by a positive-displacement mechanism and are not sensitive to changes in barometric pressure. These controls yielded an average inaccuracy of 0.52% or less for both technicians, as shown in Table 3. This confirms that the PCS is operating within its specifications and is not affected by the change in barometric pressure due to the change in altitude.
Barometric pressure, dependent on the location of the laboratory, is only one parameter that influences the accuracy of air-displacement pipettes. As mentioned earlier, pipette calibration regulations stipulate stringent control of temperature during calibration (20 ± 0.5 °C), and that all materials, including pipettes, tips, and liquids be thermally equilibrated prior to calibration.
Such thorough thermal equilibration is difficult to achieve in a typical laboratory setting. Many common assay protocols require the dispensing of reagents that are not in the specified temperature equilibrium. Common examples are tissue culture applications, which employ reagents at 37 °C, assays with nucleic acid-based reagents at 4 °C or lower, or PCR samples transferred at 60 °C or warmer.
Artel scientists investigated the effects induced by thermal disequilibrium on volume delivery of air-displacement pipettes using the same PCS system as described above. Representing real-life laboratory situations, aqueous solutions to be pipetted were equilibrated and maintained at the desired temperatures (4 °C, 22 °C, 37 °C, and 60 °C), while the pipettes and tips were kept at ambient temperatures.
Adjustable-volume pipettes from three different manufacturers were examined, covering the commonly used volume ranges of 2-20 μL, 50-200 μL and 200-1000 μL. Each pipette was tested at volume settings close to its specified minimum and maximum volumes, using tips from the respective pipette manufacturer. At each volume setting, aliquots of the different temperatures were pipetted in alternating order, until ten data points were acquired for each sample. Systematic warming or cooling of the air cushion within the pipette shaft and tip is minimized by this regular alternation. A new pipette tip was used for every sample delivery, and the tips were not pre-wetted, so that immediately prior to the aspiration, each tip was in thermal equilibrium with the ambient laboratory air.
Acquired data of each volume/temperature combination were averaged, and the dispensed volume calculated as bias versus the ambient temperature data. Low-temperature samples were consistently delivered in excess of the set volume, regardless of the pipette or its volume setting, as shown in Figure 3. Samples thermostatted at higher temperatures than ambient were consistently under-delivered, as shown in Figure 4 (37 °C samples) and Figure 5 (60 °C samples).
Figure 4
Figure 5
It is evident from these results, that the errors induced by thermal disequilibrium are not only dependent on the temperature, but also on the set volume of the pipettes. These thermal effects are significantly more pronounced when pipettes are used at or close to the minimum specified volume setting.
These results are consistent with the thermodynamic model of the pipetting process in an air-displacement micropipette. The relationship between temperature, volume, and pressure is described by the ideal gas law [PV = nRT]. Once the tip is immersed in a cold liquid, thermal conduction begins to cool the captive air inside of the pipette, leading to a reduction of air volume inside the pipette. During aspiration, this volume discrepancy is balanced out by aspirating more liquid sample into the tip, resulting in an over-delivery of sample.
The opposite effect is encountered when immersing the tip in a warm sample: the captive air inside the tip is exposed to increased temperature and expands, resulting in the aspiration of a decreased liquid sample volume.
Adjustable pipettes set at their minimum operating volume contain the same captive air volume as those set at their maximum operating volume, but less liquid is handled. Thus, the ratio of air to liquid is increased, and an identical change of volume on the air side has a larger proportionate impact on the liquid.
Experimental results are in good accordance with this model, showing a larger discrepancy in delivered volume when pipetting volumes near the minimum specified range, as compared to the nominal volume of these pipettes.
Furthermore, the study demonstrates clearly that pipettes for small volumes (i.e. in the 2-20 μL range) are more susceptible to thermal effects than pipettes designed to handle larger volumes. Considering the larger surface to volume ratios of the smallest tips, and the larger ratio of air to liquid within the tips and shafts of these small-volume pipettes, the results are consistent with the thermodynamic model described above.
In the vast majority of laboratories, researchers have no influence on the barometric pressure at the given location. It is important, however, that laboratory managers are aware of the effect pressure differences may have on the accuracy of pipetted volumes. Since newly purchased pipettes are calibrated to sea-level pressure, those pipettes may be out of specification on first use if the laboratory is located at higher elevations. Similar caution needs to be exercised if pipettes are shipped to a calibration service located at a different altitude than the laboratory in which the pipettes will be used. It is therefore strongly recommended to calibrate the pipettes either in the laboratory or at a location in its vicinity. It is good practice to verify pipettes shipped back from a calibration laboratory directly in the facility at which they will be used.
While scientists have significantly more control over the temperatures of samples, reagents, and pipettes, certain experimental protocols do not allow for full thermal equilibration of all components.
Therefore, researchers who are pipetting warm or cold liquids need to be aware that this technique is prone to introduce significant errors into common laboratory procedures. Cold liquids tend to be delivered in excess quantity, while warm liquids tend to be under-delivered. Depending on pipette manufacturer, volume set point, and temperature of the sample, these errors can exceed 65%, with small volumes to be affected most.
Whenever possible, it is recommended to pipette liquids that are equilibrated to room temperature. When using protocols necessitating the handling of cold or warm liquids with an air-displacement pipette, it is recommended that the researcher determine the pipette inaccuracy of the used pipette/tip/temperature combination prior to the experiment. Since it is not always feasible to determine the precise aberration from the calibrated volume at any given temperature, volume, and tip combination, everyone interpreting the data should be aware of the potentially very significant error introduced by pipetting warm and cold liquids.
While the influences of the environmental parameters discussed here were investigated on manually operated air-displacement pipettes, it should be pointed out that many automated liquid handlers operate by the same mechanism of air-displacement pipettes. While the effect of barometric pressure is less of an issue with these systems, as they are commonly calibrated on-site, operators should be aware that similar errors as reported above may be observed when transferring liquids of different temperatures.
Properly analyzing experimental results is one of the most important functions of any scientist. During such analyses, it is easy to overlook the potentially large errors that may be introduced by effects exerted on liquid handling equipment, amongst the multitude of other error sources.
When analyzing errors observed in experimental results, it is useful to keep these potential error sources in mind, in addition to the usual suspects, like contaminated reagents, experimental conditions, and instrument or operator errors, to name but a few.
1 Curtis, R.H. Minimizing Liquid Delivery Risk: Pipets as Sources of Error. Am. Lab. 2007, 39(7), 8-9.
2 Vaccaro, W. Minimizing Liquid Delivery Risk: Operators as Sources of Error. Am. Lab. 2007, 39(17), 16-17.
Keeping a continual focus on optimizing laboratory productivity, particularly in an increasingly global environment, Bjoern has been contributing to the development of international standards for over 10 years. He is a technical expert contributing to the efforts of standards development committees of ISO (International Standards Organization), ASTM International (formerly the American Society for Testing and Materials), and CLSI (Clinical and Laboratory Standards Institute).
Filling a void in testing guidance for users of automated liquid handling systems, Bjoern was one of the industry experts who proposed the development of the ISO International Workshop Agreement (IWA) 15 “Specification and method for the determination of performance of automated liquid handling systems,” serving as project leader and technical editor for the development of this ISO document. He is currently the project leader and technical editor for the development of a series of ISO standards (ISO 23783 parts 1, 2, and 3) slated to succeed ISO/IWA 15.
Bjoern has been contributing as technical expert to the revision of the ISO 8655 series of standards, serving as lead author and project leader for the new Part 8 “Photometric reference measurement procedure for the determination of volume” and project leader and technical editor for the revision of Part 7 “Alternative measurement procedures for the determination of volume.” He is the co-proposer, lead author, and project leader for the development of the new Part 10 “User guidance and requirements for competence, training, and POVA suitability.”
Key Roles:
Project leader for development or revision of:
– ISO 8655-7
– ISO 8655-8
– ISO 8655-10
– ISO 23783-1, -2, and -3
– ASTM E1154
– ISO/IWA 15
Technical expert in:
– ISO/TC48/WG04
– ISO/TC48/WG05
– ANSI US TAG to ISO/TC48
– ASTM E41 and E13
– CLSI
Heidi contributes almost 40 years of Regulatory Affairs and Quality Assurance experience to the Standards Leadership team. Having worked for decades in FDA-registered companies, she is well-versed in FDA regulations, audits, and inspections. As a Certified QMS Auditor, she has been responsible for all aspects of Artel’s ISO 9001 certification and ISO 17025 accreditation processes, as well as the corresponding internal audits. Additionally, she is an expert in industry-specific regulatory requirements, and ensures Artel’s continuous compliance with all applicable regulations and international standards.
Heidi serves as the secretary to the ISO working group responsible for the development of a series of new ISO standards for Automated Liquid Handling Systems, after having provided significant support to the development of ISO/IWA 15. Her standards development expertise is further applied in handling the balloting process of ISO and ASTM standards for the relevant technical committees in the US.
Key Roles:
– ISO/TC48/WG05 – Secretary
– ANSI US TAG to ISO/TC48 – Vice Chair
Responsible for:
– FDA regulations
– ISO 9001 certification
– ISO 17025 accreditation
– Internal audits
– Compliance to RoHS, REACH, TSCA, and others
Richard has been applying his scientific expertise to the development of international standards for over 25 years. He proposed and authored ISO 8655-7:2005 and ISO/TR 16153, based on the ratiometric photometric method for volume determination.
He was an active member in the ASTM International (formerly American Society for Testing and Materials) committee on laboratory apparatus, as well as in NCSL International (formerly National Conference of Standards Laboratories) through the 1990’s. In 1995, he became involved in the revision of DIN 12650 series of standards related to pipettes and other piston-operated apparatus, which led to the development of the ISO 8655 series of standards.
The co-founder of Artel, Richard was company’s original member delegate to the NCSLI – an international metrology association founded at the request of the US National Institute of Standards and Technology (NIST). This close engagement with metrology and measurement excellence was formative in the development of Artel’s measuring systems and laboratory capabilities.
He authored numerous papers and presentations on the topic of pipette calibration, which are referenced in compliance standards, such as the checklists issued by CAP (College of American Pathologists).
Key Roles:
Author of:
– ISO 8655-7:2005
– ISO/TR 16153:2004
– Performance verification of manual action pipettes, Am Clin Lab 1994
– Referenced in CLSI GP-31 A
– Referenced in CAP checklists
– NCLSI member delegate and appointing officer
– ASTM E41 member since mid-1990’s
George has been engaged in international standards and metrology for more than 20 years – working with colleagues at ISO, ASTM International (formerly the American Society for Testing and Materials), CLSI, and NCSL International (formerly the National Conference of Standards Laboratories).
He chairs the ISO working group responsible for the development of the new standard for Automated Liquid Handling Systems, after having co-proposed and chaired the development of ISO/IWA 15, which was published in 2015. He is the former chair of the ISO working group responsible for pipettes and other piston-operated apparatus, where he proposed the development of a new ISO standard for the “Photometric Reference Measurement Procedure for the Determination of Volume” (ISO 8655-8). George is also a technical expert in the revision of all parts of the ISO 8655 series of standards and proposed the development of the new ISO standard on Operator Training and Pipetting Technique.
His deep expertise in metrology is applied in the current revision of the ISO technical report on the estimation of uncertainty for the photometric reference method, numerous articles, as well as across Artel’s product line.
Serving as chair of the US technical advisory group to the ISO technical committee responsible for laboratory equipment, George is responsible for achieving consensus among US experts and articulating this US consensus positions the ISO international technical committee.
George chairs the ASTM sub-committee on laboratory apparatus and serves as secretary to the parent main committee. His metrology expertise was applied in the revision of the balance calibration standards ASTM E898 and E617, which is referenced in the USP (United States Pharmacopeia).
He co-authored the chapters about pipettes and liquid handling processes in the current edition of CSLI QMS-23.
Key Roles:
– Co-author of:
– ISO 8655-7
– ISO 8655-8
– ISO/TR 16153
– Proposer of ISO/IWA 15
– Proposer of ISO 23783-1, -2, -3
– CLSI QMS-23 – Contributing Author
– ISO/TC48/WG05 – Convenor
– ISO/TC48/WG04 – Former Convenor
– ASTM E41 – Secretary
– ASTM E41.06 – Chair
– ASTM E898:2020 – Revision Participant
– ASTM E617:2018 – Revision Participant
– ASTM E1154 – Technical Contact
– ANSI
– US TAG to ISO/TC48 (Laboratoy Equipment) – Chair
– ANSI International Forum – Participant
– NCLSI – Member Delegate & Healthcare Metrology Committee
Kathleen extends Artel’s commitment to using innovative processes for error-free results to Artel’s finance-related activities. Responsible for financial planning and analysis, evaluating strategic opportunities, budgeting, benefits, and compensation, Kathleen uses her long history of doing mergers and acquisitions from a consulting and business side to bring analytical excellence to strategic evaluations, and her experiences at larger companies to advance established processes.
When not at Artel, Kathleen uses all her experience in efficiency and productivity to care for her two daughters and their cat, dog, and horse and, in the very little time left over after that, enjoys travelling to other countries, meeting new people and learning about other cultures.
“Live life as if you were to die tomorrow. Learn as if you were to live forever.” Mahatma Gandhi
Bernadette is the driving force (and friendly face) behind Artel’s content-heavy and customer-centric approach to marketing. She develops marketing/branding strategies and communications campaigns, and leads program execution and analysis by coordinating internal and external efforts, managing budgets, and ensuring consistency and adherence to Artel’s high standards.
Bernie’s strength lies in her ability to reach across all disciplines at Artel—scientific, engineering, metrology, technical support, product development, production, sales, and field support—to make sure that customers are getting the valuable information they need.
Bernie’s passion for detail, quality, and authentic content is expressed in her extraordinary culinary skills, whether the cooking is for an (extensive) family gathering or making a meal for the local community teen center.
“What people do with food is an act that reveals how they construe the world.” Marcella Hazan
John keeps one eye on the latest technologies and another on the challenges facing today’s life science labs. He and his team of eagerly engaged scientists and engineers test new ideas to enhance Artel’s current products and build out tomorrow’s solutions.
Like many Artelians, John is driven by a lifelong curiosity in the physical world around him. He has turned his fascination with spectroscopy and understanding how light interacts with molecules into products that solve real-world productivity and quality challenges for scientists. He was part of the original team that created the MVS and has been involved in product development at Artel since he walked through the front door.
Descended from a family whose motto is probably best expressed as “do a job right, do it completely, and don’t let go until it’s done,” John embodies this philosophy during the day at Artel. He propagates that motto to his kids through gardening, tapping Maple trees and exploring the great backwoods and waterways of Maine.
“It ain’t what you don’t know that gets you into trouble. It’s what you know for sure that just ain’t so.” – something Mark Twain may, or may not, have said…probably
Wendy puts her years of experience in the laboratory and her passion for helping people and problem solving to good use as Artel’s Technical Services Manager. Her background has given her hands-on knowledge of customers’ tests and assays, enabling her to understand their pain points since she has experienced them herself. Her goal is to ensure that first-class service is provided by Artel’s customer-facing team, whether it’s directly interacting with customers or through her management of the team. Through hiring, training and guiding her team, she nurtures productive, long-lasting customer relationships.
Wendy’s focus on customers also makes her an excellent internal customer representative to Artel’s teams, where she provides input on product development to the R&D team and communicates any quality issues with Artel products and services to the operations team.
Wendy’s drive to help others resolve problems is not limited to Artel but is evident in all aspects of her life, especially with her children. When not assisting customers, Wendy likes to stay active by biking, boating, and taking long walks in beautiful Maine.
“Nobody cares how much you know until they know how much you care.” commonly attributed to Theodore Roosevelt
Richard combines his scientific education, love of learning, curiosity, and passion for making things work better to build products that help life science labs meet quality and productivity goals. His favorite challenge is finding the bullseye at the intersection of corporate strategy, market need and available technology, and then figuring out how to create a product which hits that target. His leadership has been instrumental in shaping Artel’s products and services into the effective, easy-to-use, and quality-focused offerings that they are today.
When not creating tools and knowledge to help life science labs get the right answers every time, Richard enjoys the great Maine outdoors—canoeing, camping, and gardening—as well as woodworking (usually in the great Maine indoors).
“When you have eliminated every possibility for inaccuracy, then accuracy remains your only option.”
With years of pharmaceutical industry experience centered around analytical chemistry, automation, and new technologies, as well as a background in teaching assay development and validation, Nat’s a natural in his role at Artel as the primary driver and chief communicator of product applications. From optimizing assays, processes, and workflows to pipette user training and calibration, Nat communicates to customers how Artel products and services can improve quality and productivity.
At the same time, he keeps track of key assay trends and applications to inform new product development and strategic guidance for business development, partnering, and collaborative opportunities.
While typically a casual and friendly person at Artel and at home, Nat’s aggressive commitment to quality comes out when he homebrews beer and other fermented beverages and he’s even been known to kick people out of the kitchen to avoid contamination.
“Fast is fine but accuracy is everything.” Wyatt Earp
As a co-founder and President, Kirby’s role at Artel is similar to that of an orchestra conductor—he melds the different elements of the company into a powerful whole, bringing out the best in his colleagues and creating synergies that together overcome customer challenges in liquid handling, quality, and regulatory compliance.
Through a combination of curiosity and discipline, creativity and precision, he works with his fellow Artelians to build outside-the-box solutions that are efficient, easy-to-use, highly effective and based on science. Their goal: to ensure that each customer finds new opportunities and executes new solutions to achieve productivity and compliance objectives.
When not at Artel, Kirby takes up his own instruments, the saxophone and piano, playing for the approval of Charlie Parker and Gabriel Faure.
“Music is your own experience, your thoughts, your wisdom. Master your instrument, master the music. If you don’t live it, it won’t come out of your horn.” Charlie Parker
As the Production Manager, Jim maximizes Artel’s productivity and quality by ensuring that all supplies and components are in place, providing proper training for production personnel, maintaining effective processes, and supporting an overall positive, sound and safe working environment.
Driven by a desire to help others, Jim uses his 30-plus years of experience in the photometric instrument field to ensure that customers know they can rely on Artel, answering questions, solving problems, and guiding them through to complete resolution of any issues they have with their lab’s systems.
Like many at Artel, Jim enjoys cooking and home renovation, and is currently combining his helpfulness and home renovation skills by working on his daughter and son-in-law’s house.
“Seek first to understand, then to be understood.” Stephen R. Covey
An important part of building high-quality products, and providing services that rely on those products, is ensuring that the components and supplies are also high-quality and readily available. Which is why Jack focuses on keeping supply-side relationships top notch. Responsible for the extended supply chain—procurement, purchasing, inventory control, warehousing, shipping, and trade compliance—as well as Artel’s facilities and physical plant, Jack ensures quality by being both a good customer and delivering good customer service.
Jack’s adherence to high standards, quality, and attention to detail are a great fit for his work at Artel and can also be seen in the years-long home renovation project he and his wife have been undertaking. When not at Artel, Jack is an avid traveller, gardener, and connoisseur of cinema and literature.
“No one knows the cost of a defective product – don’t tell me you do. You know the cost of replacing it, but not the cost of a dissatisfied customer.” W. Edwards Deming
Officially, Graham is responsible for overseeing sales, strategic marketing, business development, and applications of Artel’s technology. In practice, this means listening to customers and leveraging his broadly eclectic scientific and business background to identify technological solutions that improve data quality and productivity.
Initially trained as a molecular biologist/protein biochemist, his many years troubleshooting misbehaving assays and analytical methods make him particularly well-suited to a role helping customers with their data quality. The many years at the bench have given Graham a deep appreciation of the importance of reducing sources of noise and variability which, together with experimental controls, can help save weeks and even months of wasted time.
When not at work, Graham’s total embrace of the experimentalist’s spirit is evident in his approach to cooking and baking, also known as “the experiment you get to eat,” which requires precision and tight QC of the ingredients as well as exact execution of the recipe steps to get the desired tasty outcome.
“I often say that when you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind.” Lord Kelvin
With a specialization in metrology and a lifelong interest in both science and engineering, George is ideally suited for his role as Artel’s representative to metrology and standards organizations, laboratory accreditation bodies, and government regulators, where he helps shape regulatory frameworks around liquid handling processes.
These activities give George a deep understanding of regulatory compliance which, coupled with his metrology and quality expertise, he uses to help customers improve data quality and efficiency while maintaining regulatory compliance. This help is especially critical for customers making process improvements, as change can be challenging in regulated environments.
George’s interest in metrology and standards extends beyond his work at Artel (see how he celebrated World Standards Day in 2016). For example, in George’s words, “Deflategate could have been avoided with a properly defined and validated measurement process. With no stated reference temperature, the NFL cannot possibly regulate ball pressure to plus or minus 0.5 psi. A game of inches and seconds, $15 billion annual revenue, and zero metrologists!”
“Every system is perfectly designed to get the results it gets.” Often attributed to W. Edwards Deming, but more likely from Paul Batalden.
As the person in charge of Artel’s Quality Management System, Cary plays a critical role in making sure that Artel’s commitment to quality is always being met. By training employees and keeping all quality processes and procedures well-documented and up-to-date with current regulatory standards she ensures regulatory compliance, and by assessing and evaluating performance both internally and externally (Suppliers) and customer feedback, she supports overall productivity and effectiveness to ensure we meet our customers’ expectations.
When not working closely with her team members to maintain Artel’s quality management processes, Cary enjoys the peace found hiking in the beautiful Maine outdoors.
“Nature does not hurry, yet everything is accomplished.” Lao Tzu
“Random is not one of my strengths.” Doreen Rumery
With a strong work ethic, thorough attention to detail, inquisitive mind that needs to know why things work (or don’t work), and passion for standardization, Doreen is exactly the right kind of person to manage Artel’s chemistry and calibration labs. She’s responsible for making sure the labs run smoothly, ensuring product and instrument quality, calibrations, regulatory compliance, lab personnel training, timely delivery of products, troubleshooting, and process improvements.
Doreen’s need for standardization is apparent even in her home life where spreadsheets and planning tools are used to ensure the household runs smoothly. When not at Artel, Doreen likes to spend time with her family (some of whom she also sees at Artel), gardening, and travelling with her many sisters and brother.
“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives.” William A. Foster
Table 1. Regulations that require demonstration of pipette competency training and/or assessment
ISO Standards | |
ISO/IEC 17025:2005 | General Requirements for the Competence of Testing and Calibration Laboratories |
ISO 15189:201 | Medical Laboratories; Requirements for Quality and Competence |
ISO 15195:2003 | Laboratory Medicine; Requirements for Reference Measurement Laboratories |
FDA cGMP regulations (current Good Manufacturing Practice) | |
21 CFR Part 211 | cGMP for Finished Pharmaceuticals |
21 CFR Part 225 | cGMP for Medicated Feeds |
21 CFR Part 820 | Quality System Regulation for Finished Devices for Human Use |
21 CFR Part 1271 | Human Cells, Tissues, and Cellular and Tissue-based Products |
GLP (Good Laboratory Practice) | |
FDA: 21 CFR Part 58 | GLP for Non-clinical Laboratory Studies |
EU: Directive 2004/10/EC | Principles of Good Laboratory Practice 1997 (Part 1), from the Organisation for Economic Cooperation and Development (OECD) |
GCP (Good Clinical Practice): | |
International Conference on Harmonization (ICH) E6 | Good Clinical Practice – Consolidated Guidance 1996 |