Successful assay transfer ensures that new results are comparable to historical data. Whether it involves scaling an assay up to a higher throughput platform or transferring an assay from development to a QC environment, assay transfer is challenging because of the large number of variables involved. Differences in equipment, reagents, technique and interpretation of methodology are typically the focus of preparation before assay transfer. Less obvious variables, such as those that involve liquid handling, are often the cause of assay transfer failures. These frequently ignored variables are difficult to identify and, therefore, to troubleshoot.
Liquid handling instruments, such as pipettes and automated liquid handlers, are routinely used to perform assays in laboratories. Their accuracy is often taken for granted and, therefore, not given proper attention during assay transfer work. Understanding the importance that liquid handling plays in assay transfer work and taking measures to control liquid handling variables will ultimately facilitate assay transfer.
For example, errors in liquid delivery can often be unnoticed, undocumented, or misunderstood. These errors may come from one or more sources, such as pipettes, liquid handlers, operators, environmental conditions, and labware.1-4 Liquid handling errors propagate and can significantly impact the assay. These errors result in the time-consuming challenges of diagnosing and troubleshooting the problem, hence jeopardizing the process before the assay is successfully transferred.
Successful assay transfers are a product of careful planning and advance preparation. Preventing liquid handling problems during execution involves pre-transfer work, such as understanding the assay, focusing on training and calibration, and generating effective documentation.
Understanding the liquid handling steps in the assay is important because variable liquid delivery will alter analyte and critical reagent concentrations, which in turn affect the accuracy of the assay.
Begin by identifying the critical liquid handling steps in the assay. To accomplish this, list all the liquid handling steps performed and describe their execution in detail, drawing on the parameters compiled in Table 1.4 Using this detailed list, evaluate the risk at each liquid handling step, and pinpoint the areas that could be problematic during transfer.
Next, evaluate the accuracy of the volume delivery that will occur at the critical steps between the assay transfer sites.5 Table 2 lists the common methods for evaluating volumetric performance. Implementing a volume verification process ensures that the performance of liquid handling instrumentation is known, which allows laboratories to achieve the same relative analyte and reagent concentrations in the assay at both the transferring and receiving sites.
Table 1. Parameters That Affect a Working Assay |
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Assay ParametersPlate or tube format (96, 384, etc.) |
Instrument ParametersTarget or off-set volume |
Laboratory ParametersOperator skill and technique standardization |
Table 2. Common Methods Used to Evaluate Liquid Handler Performance |
|
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Method | Description |
Gravimetry | The liquid is dispensed into a container and the container is weighed on an analytical balance; the liquid density value is used to calculate volume transferred by the pipette. |
Absorbance | A dye-based solution is dispensed with the liquid handler and, depending on the extent of the methodology, the absorbance data are correlated to the volume precision and accuracy. |
Fluorescence | A fluorescent dye-based solution is dispensed with the liquid handler and, depending on the extent of the methodology, the fluorescence data are correlated to the volume precision and accuracy. |
Dual-dye Photometry | Dual-dye, dual-wavelength ratiometric photometry is used to assess accuracy and precision of volume transfers in one measurement. |
Combination of Methods | Combining some of the above methodologies helps achieve precision and accuracy information. For instance, an absorbance method to determine precision can be combined with a gravimetric method to determine accuracy. |
Pipettes and liquid handlers require calibration and preventive maintenance schedules that ensure the accuracy, precision and trueness of each volume dispensed under normal operating conditions. Properly maintained and calibrated volume delivery instrumentation at the transferring and receiving sites is an easy-to-control variable that minimizes assay transfer failures. Calibrating to a known standard available at each site will further reduce the potential for failures.
Further, technologists pipetting skills can be a relatively large unknown source of error2 encountered during assay transfer. Operator error may go undetected, resulting in poor assay performance and failed assay transfers. Figures 1 and 2 illustrate the differences in pipetting skills in terms of precision (%CV)and trueness (%SE), before and after training for fifty-three QC technologists. A significant improvement in pipetting skill was observed post-training. Hence, a comprehensive training program is necessary to control the variable of technologist pipetting skills, and to standardize pipetting technique, prior to assay transfer.
Generating effective documentation is another critical part of pre-transfer work. A detailed standard operating procedure (SOP) describing the assay, as it is executed in the transferring site, is key because it provides a standard for training and executing at the receiving site.
Robust and detailed SOPs created during or after assay development at the transferring site provide information that can further define assay steps to reduce problems at the receiving site. For instance, detailing the liquid handling steps in Pre-Transfer Activity #1 will allow the receiving site to focus on details that may have otherwise been overlooked, and will ultimately lead to a successful transfer.
Another important documentation component is the transfer protocol. A formal protocol defines the expectations for the transfer exercise, provides agreement between the sites on how the transfer will be executed, and defines the criteria for a successful assay transfer. A comparison between the results for identical samples at both sites is required, and an equal number of determinations for each sample at each site is advisable to simplify statistical analysis. Analytical precision studies including repeatability, intermediate precision and inter-laboratory reproducibility are recommended.6 Poor precision in liquid handling can have a direct effect on repeatability, while poor liquid handling accuracy would contribute to poor reproducibility. Finally, analytical accuracy is evaluated by determination of the percent difference for results for identical samples at both sites using the results of the transferring site as the “true value.”6 So, it is important that liquid handling accuracy be consistent at both laboratories.
A complete, successful assay transfer is the foundation for ensuring that comparable, high quality results are generated at the receiving site. Sustaining the knowledge obtained during the execution of a method transfer in a new site involves robust SOPs, method maintenance and, as mentioned in Pre-Transfer Activity #2, strong training and calibration programs.
Proper and detailed documentation captures method nuances discovered during the transfer exercise. SOPs are typically refined after the assay is transferred to clarify and expand on the instructions provided in the original document. Furthermore, assay controls implemented as part of the transfer process must be added to the SOP to guarantee the assay is executed correctly.
Maintaining a transferred method can be accomplished in many ways, depending on the purpose of the assay. Comparability studies, trending assessments and regular revalidation schedules are typically put in place to ensure that the transferred assay continues to perform as expected.
Preventing liquid handling problems during execution involves pre-transfer work, such as understanding the assay, focusing on training and calibration, and generating effective documentation.
Liquid handling steps are a controllable but often ignored variable in assay transfers. Understanding the impact of volume delivery on the assay, implementing appropriate pipette and liquid handler calibration and training programs, and developing effective documentation that addresses the details of liquid handling steps are pre-transfer preparation activities that are essential to the success of an assay transfer. They allow the transferring and receiving sites to approach the assay transfer with confidence by eliminating variables and, therefore, improving the chances for success. Once an assay is successfully transferred, these strategies are still applicable to sustaining the assay at the new site by, for example, keeping the equipment functioning properly and capturing method details in SOPs.
Several pipetting actions can contribute error to a laboratory process. Failing to pre-wet the pipette tip can lead to inaccurate liquid delivery by delivering lower volumes than expected. Excessive tip wiping can also cause sample absorption and under-delivery. Choosing the wrong pipetting mode is another common error. For instance, reverse mode pipetting can be more ideal for viscous samples, whereby the plunger is depressed past the first stop to aspirate the aliquot from the sample, and depressed only to the first stop to deliver the aliquot. Finally, variability in the temperature of the liquid significantly contributes to error in pipetting. For more information, see Reference 2.
When using disposable tips, the tip quality and characteristics are critical to the integrity of the volume transfer. Vendor-approved tips, as opposed to the less expensive ‘bag of tips’ option, should always be employed to minimize volume transfer error and optimize liquid delivery quality. Disposable tip performance has been found to be directly related to quality because tip material, shape, properties, fit and wet-ability are all important factors for repeatability. The cheaper, bulk tips may not be manufactured with the highest precision manufacturing and may have variable characteristics that affect delivery, such as differences in upper diameter, virgin plastic content and presence of plastic residue inside the tip, known as “flash.” These tips also might not fit well on the liquid handler and they may have variable
wetting/delivery properties. Without using approved tip types, accuracy may be at risk. See Reference 1 for more information.
Fixed tips are usually stainless steel pipetting channels which are used repeatedly, often with wash steps between pipetting steps. These tip types may also present sources of variability in liquid delivery with automated liquid handlers. Continued use of fixed tips with caustic reagents may degrade the inside surface of the tips and create grooves or pockets in the tip material. Liquid may fill the formed cavities during volume transfers resulting in carry over, contamination or even over-delivery of solution to critical assays. Additionally, many liquid handlers that use fixed tips require system fluid to aspirate and dispense the sample volume (and the system fluid aids with the washing steps between pipetting events). Error can creep into a process when insufficient air gaps are employed between the system fluid and sample volume, which results in a diluted sample, i.e., less concentrated sample volume and cross-contaminated system fluid. For more information on identifying sample dilution from system fluid as well as circumventing such issues, see References 7 and 8.
With a focus on ensuring that Artel delivers meaningful and measurable value to the company’s customers—whether that’s accelerating time to market, delivering cost savings, or driving intellectual property creation—Rosario approaches his role as Vice President of Business Development as one of partnership and collaboration.
He has spent his career bringing complex technologies to scientific and medical professionals and has found success through close engagement with customers. By truly listening and understanding his constituents’ needs, Rosario is able to translate a technology’s value into measurable and sustainable benefits. Newly part of the team, he is already making an indelible mark both in-house and with the users of Artel technology.
When not focusing on customer success or being corralled by colleagues into proofreading their documents (that’s what an inborn commitment to excellence gets you), Rosario brings joy to his friends and family in the form of cooking and opera singing.
“Strive not to be a success, but rather to be of value.” – Albert Einstein
A sales manager responsible for leading a team of skilled account managers, distributors and consultants, Tanya brings together a deep understanding of Artel technology and customer needs to drive success for her team and for Artel’s customers.
Her insight into the benefits provided by Artel technology is based on her experiences as part of the original R&D team that developed the MVS. With the belief that technology untethered from customer needs is ineffective, she moved into marketing to learn how the system she helped develop can enable Artel’s customers to achieve their goals. Now as a sales manager, Tanya is focused on expanding the number of life science teams that Artel can help, whether they are developing and manufacturing tomorrow’s cures or ensuring health through accurate assays.
Like many at Artel, Tanya likes to enjoy the great Maine outdoors with her family when not at work, by camping and traveling to the many wonderful state parks.
“Precision is, after all, not a form of responsibility and a kind of pleasure, but an instrument of compassion. To be precise requires care, time and attention to the person, place or process being described.” – Marilyn Chandler McEntyre
Morgane’s mission is to enable customers and potential customers to quickly and easily understand how Artel’s technology can help them optimize their assay workflows by clearly communicating everything Artel. From how the technology works in specific applications to challenging set up of liquid handler processes and tuning in of complex assays, Morgane is making Artel’s technology understandable and accessible to all.
Having been both hands-on at the bench and with scientific project management, Morgane understands the ins and outs of customers doing research and providing scientific services. She looks forward to satisfying her innate curiosity by learning about the needs of all of Artel’s many types of customers.
When not translating Artel technology into easy-to-grasp communications, Morgane relaxes by folding herself into knots practicing and teaching yoga, traveling back to her native France, expanding her proficiency at a variety of arts, and marveling at how all of these activities feed back on and are driven by the nervous system.
“After a certain high level of technical skill is achieved, science and art tend to coalesce in esthetics, plasticity, and form. The greatest scientists are always artists as well.” – Albert Einstein
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
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
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
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
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 |