The use of high-quality precision liquid handling instruments throughout the drug discovery, testing and production processes has tended to give scientists a sense of confidence in their data. However, the large amount of resources dedicated to drug development, the long FDA approval process, and the numerous recalls and legal actions plaguing several well-known drug companies suggest that more attention be paid to quality assurance. In particular, liquid handling processes, core to pharmaceutical laboratory operations, demand the application of robust, rigorous, science-based methods and tools to ensure data quality.
In life science laboratories, where technological breakthroughs are common, scientists often have a variety of tools available to complete everyday tasks, including liquid handling quality assurance. There are several options available to laboratories to calibrate liquid handling instrumentation and measure the efficacy of liquid handling processes, each with their own applications, benefits, and drawbacks. The optimal technology for each laboratory application depends on a variety of factors, from the volume of liquids to be quantified to the type of instrumentation used and the applicable regulatory and quality standards. Also to be considered are the laboratory environment, tolerance for risk, required calibration frequency, and the demands of the laboratory’s processes.
This article will compare gravimetry, fluorometry, single-dye photometry and ratiometric photometry – all common means for verifying liquid handling instrumentation – and will provide data and guidance regarding best applications of each.
Traditionally, laboratories have relied on gravimetry to measure the performance of liquid handling devices. This method uses a balance to weigh liquid volumes. The balance reports a weight and that weight is converted to mass and then to volume using conversion factors, which may be found in tables, calculated from formulas, or produced by software packages.
Gravimetry has several advantages, including the wide availability of weighing devices in most laboratories. In addition, gravimetry is a well-accepted technology. It is recognized by national and international regulatory agencies, including the International Organization for Standardization (ISO), the College of American Pathologists (CAP), and ASTM International. Published standard methods of gravimetry include ASTM E1154 and ISO 8655-6. Gravimetric calibration can also be traced to national standards, facilitating regulatory compliance and standardization.
Gravimetry is frequently the method of choice for measuring device performance when handling larger volumes. For example, a 1,000 microliter aliquot weighs approximately one gram and can be weighed reliably on a modern laboratory analytical balance. However, the current trend in laboratories toward handling smaller liquid volumes with automated devices is illustrating one major drawback of this method – as volumes decrease, weighing becomes more challenging for several reasons.
First, measuring smaller liquid volumes requires more specialized balances (producing measurement results to five or six decimal places on the gram scale). Such balances are delicate, require a stable platform to limit vibration, and are not as portable as the less sensitive models used for measuring larger liquid volumes. These requirements often make microgram balances not well-suited for use on the deck of automated liquid handlers. Illustrating the need for sensitivity, ISO 8655-6 requires that volumes 10 microliters or smaller be measured on a six-place (microgram) balance.
Because microgram balances take some time to settle, gravimetric calibration can also be time consuming. In addition, gravimetry is affected by a variety of environmental conditions, including evaporation, static electricity, and vibration. And as volumes become smaller, these error sources become more significant.
For example, modern dispensing equipment can deliver volumes so small that they can evaporate in a matter of seconds. Obtaining adequate resolution for small volumes requires a highly sensitive balance with complicated evaporation traps, static eliminators, and vibration dampeners. Other methods for controlling for evaporation can be complicated. One method is to measure the evaporation rate and correct for the resulting volume variation. Alternatively, the humidity in the room can be increased or a draft shield built to prevent air from flowing over the testing area. These steps add time and complexity to the measurement process.
Electrostatic effects also cause some uncertainty with gravimetric methods because plastic pipette tips are typically used to transfer liquids. Static electricity that is imparted to the balance pan or the draft shield induces a force that affects measurement accuracy and, when working with small volumes, the error can be significant. Vibration must also be controlled for, and this often requires calibrating in a controlled environment on a solid marble bench.
Because gravimetric measurements calculate volume by converting weight to mass and then to volume, accurate calibration is contingent on knowing the density of the fluid being pipetted. Many laboratory technicians assume the fluid being measured has the density of one, which is the approximate density of water. Although common solutions do have published density values, the densities are not always known to a high degree of accuracy.
To illustrate the possible uncertainty, consider DMSO, whose published density is 1.1 grams per milliliter. Note that the density is published with limited resolution, using only two significant figures. In addition, the density of DMSO changes depending on its water content, which depends on the starting water content and time exposed to ambient local temperature and relative humidity. Even the density of water varies with temperature and, at room temperature, is always less than one gram per milliliter, its commonly accepted value.
These details need to be accounted for if very precise measurements are required. Consider a device with accuracy specifications of better than 0.6 percent, which is a typical specification for high-accuracy pipetting of 1,000 microliters. Failure to correct for density errors, even when pipetting water, can lead to error in the 0.3 to 0.5 percent range, which is nearly as large as the acceptable error for the entire piece of equipment. However, when acceptable tolerances are in the five to ten percent range, density considerations are much less important.
An alternative to referencing published density values is to measure density with a commercial densitometer or pycnometer. For reliable results, these instruments require calibration just like other laboratory instruments and require care to avoid measurement error.
One last drawback of gravimetry is the inability to simultaneously measure each individual channel in multichannel liquid handling devices. With gravimetry, individual aliquots can be measured, or multiple dispenses may be made and the total weight then used to calculate the average volume. However, to measure the performance of single channels, each channel has to be tested one tip at a time, and this is time consuming and tedious. Testing each channel one time in a 96-channel device, for example, would require 96 dispenses.
In summary, gravimetric calibration is best suited for measuring the performance of single-channel devices handling larger liquid volumes, usually above 200 to 1000 microliters (the precise lower limit for effective use of gravimetry depends on the tightness of the tolerance to be met and the quality of the measuring equipment and procedure employed).
During fluorometric calibration, a beam of ultraviolet light is shone on a sample at one wavelength, called the excitation wavelength. This causes the molecules to absorb light and enter an excited electronic state. Release of this excess energy results in the emission of light at a different, longer wavelength, called the emission wavelength. A detector is used to measure how much light is emitted at the emission wavelength. Precision is measured by comparing relative fluorescence levels in different samples.
Fluorescent dyes are very photoactive and are capable of generating a strong signal at very low volumes. Small samples can thereby generate large signals at low concentrations and this facilitates fluorometry’s use in measuring small volumes, with measurements as low as five nanoliters possible.
A major drawback of fluorometry is the difficulty in achieving a robust traceability, which often prevents its use in regulated laboratories. This deficiency is due to the fact that the strength of the fluorescent measuring signal varies depending on local chemical environment, so factors such as solvent composition, pH, ionic strength, redox potential, time, etc., can alter the signal strength. This means that during a given measurement, the volume in a well can be compared to a volume in the previous well provided that all have very similar chemical composition. However, it is difficult to compare measurement readings day-to-day, assay-to-assay, or location-to-location unless traceability is established, typically by developing a standard response curve using a calibrated pipette, or other traceable liquid delivery device.
Yet, the accuracy and traceability of this standardization depend on many factors, and at small volumes (where fluorometry is most often used) this sort of standardization can be difficult. For this reason, fluorometry is most often used to determine precision only and not accuracy, leaving the user to estimate how close the actual dispense is to the desired volume. Work is currently in progress to develop better traceability for fluorometric calibration methods.
Fluorescence methods are also affected by quenching and photo bleaching. Fluorescent dyes can chemically degrade over time and are sensitive to temperature and pH. Some dyes are buffered, meaning they contain chemicals to prevent the pH from changing. However, unbuffered dyes suffer from pH shifts as the dyes absorb carbon dioxide from the air and become more acidic. This can affect the accuracy of the measurement reading. And because the properties of fluorescent dyes can shift in hours, standard curves should only be relied on for short periods of time. In addition, there are no commercially available fluorometric calibration technologies, although there are some published methods in scientific literature.
In summary, fluorescent calibration is best suited for demonstrating precision across nearly identical conditions when testing small liquid volumes and when accuracy and traceable measurements are not required.
Photometric calibration requires a photometer and stable dyes that absorb light in the visible or ultra-violet range. To use single-dye absorbance photometry to measure volumes, a dye solution is delivered into a cuvette, a measuring cell, or a clear-bottomed microtiter plate. A beam of light at a specified wavelength is passed through the solution and the photometer measures the quantity of light that passes through. The amount of light that is absorbed is proportional to the amount of dye present, permitting a volume determination to be made.
The photometric method produces good precision measurements and is less sensitive to environmental conditions than gravimetric and fluorometric calibration technologies. In addition, although photometric dyes do change due to temperature and pH, they tend to be more stable than fluorescent dyes. This means that the response from the photometric reader will be more consistent. In addition, photometry is typically immune to the presence of other chemicals that can have a large impact on a fluorescence signal. Therefore, photometry is better suited than fluorometry for making accuracy determinations.
Another benefit of photometric calibration methods is the ability to provide information about each channel in a multichannel device. Absorbance dyes that are readily available and commonly used include tartazine and potassium dichromate. There is also a commercially available single-dye method for single-channel pipettes that is commonly used in the clinical laboratory industry.
ISO 8655-7 recognizes the use of single-dye photometry for liquid handling device calibration. However, according to this standard, photometric methods should be accompanied by an uncertainty analysis that describes the measurement uncertainty. This analysis may include error contributions such as accuracy of the photometer and reagents, dye instability, deviation from ideal Beer’s Law behavior and the like.
To account for the dyes as a source of error, data on the stability of the dye, either from the manufacturer or developed in-house through a stability or validation study, is important. Because light is passed through the sample and an optical wall, the optical quality of the microtiter plate or cuvette used in the method can affect the accuracy and precision of the measurement, and laboratories must also account for this.
Like all dye-based methods, photometric methods must be properly standardized to obtain quantitative results for accuracy measurements. The traceability of the method depends on many factors, including how carefully the standardization is carried out. For traceable photometric readings, a standard curve must be developed by using a known liquid delivery device (calibrated pipette) or by weighing volumes. This process can be time consuming and tedious. In addition, it assumes that the liquid handling device used to develop the standard curve is reliable, and this adds a level of uncertainty.
In summary, single-dye photometric calibration is well-suited for measuring precision, particularly when handling volumes too small to be weighed on a balance. Accuracy measurements can also be made, however their robustness is limited due to the difficulty of ensuring that the method is properly standardized and an uncertainty analysis yields acceptable performance.
The ratiometric photometric calibration method is a refinement of photometry designed to overcome the accuracy limitations of traditional single-dye photometric volume measurements. Ratiometric photometry employs two standardized dyes and its measurement process produces absorbance readings in pairs that can be combined into absorbance ratio readings.
The primary benefit of this approach is its ability to improve the accuracy and robustness of measurement in comparison to non-ratiometric methods. Absorbance ratios can be measured more accurately than individual absorbances, leading to a higher degree of accuracy and precision in ratiometric methods versus traditional single-dye photometric methods. The underlying reason for this is that the absorbance of photometric calibration standards drifts over time, while ratios exhibit greater stability.
Compared to gravimetry, this method offers greater speed, ease-of-use and enhanced accuracy in small-volume measurements. Compared to fluorometry, ratiometric photometry provides accuracy as well as precision measurements and can do so to a traceable standard because the dyes function as an internal standard. Measuring the second dye in comparison to the first dye provides a nearly automatic compensation for the most common photometric error sources.
Systems based on ratiometric photometry provide information about each individual channel in multichannel devices and good reproducibility plate to plate. However, for ratiometric photometry to produce benefits, it must use well-characterized plates and carefully calibrated solutions of good stability.
In addition, to function properly, ratiometric photometric methods require use of specially formulated dyes in order to produce accurate absorbance ratios. Lastly, this technology is not always preferred when measuring only larger volumes, as other technologies may produce adequate measurements more cost effectively.
In summary, ratiometric photometry calibrations provide strong benefits when measuring small liquid volumes for protocols requiring traceability and a high degree of accuracy per channel as well as precision.
Pharmaceutical laboratories have varying protocols, processes and requirements and these can affect the choice of calibration technologies for liquid handling devices. Gravimetry, fluorometry, single-dye photometry and ratiometric photometry are common means for verifying liquid handling instrumentation, each with their own advantages and disadvantages. Understanding the assay and laboratory quality requirements, traceability needs, and tolerance for error as well as the level of accuracy and precision required can help laboratories make the right decision.
Table 1: Comparison of Calibration Technologies | ||
Method | Strengths | Weaknesses |
Gravimetry | › Good accuracy at high volumes
› Balances are usually readily available › Offers traceability via weight sets |
› Problematic at low volumes
› Precision depends on environment |
Fluorometry | › Good precision
› Capable of low-volume measurement |
› Limited accuracy
› Poor traceability |
Single-Dye Photometry | › Good precision
› Insensitive to environment |
› Limited accuracy
› Traceability depends on preparation |
Ratiometric Photometry | › Good accuracy at all volumes
› Good precision at all volumes › Insensitive to environment › Traceability facilitated by dual-dye approach |
› Requires accurate photometer
› Requires accurate reagents |
About the Authors:
Richard Curtis, PhD, is Technical Director at Artel. As well as overseeing the company’s strategic direction, Dr. Curtis manages Research, Development and Engineering activities, directing the advancement of Artel’s core technology through new platforms, evolution of current products, and continued introduction of new applications. He leads the Artel technical team in the development of proprietary technology and in securing patents in photometric analytical systems, electronic circuitry, optics, and engineering physics. Dr. Curtis earned a BA cum laude in Physics at Harvard and a PhD in Nuclear Physics at Brown University.
George Rodrigues, PhD, is Senior Scientific Manager at Artel. Dr. Rodrigues is responsible for developing and delivering communications and consulting programs designed to maximize laboratory quality and productivity through science-based management of liquid handling. In his role as Artel’s leading consultant, he has assisted numerous leading firms in the life sciences ensure their laboratory data integrity while improving their process efficiency. He participates in a number of international and national standards and quasi-regulatory bodies in the fields of metrology and liquid handling. Dr. Rodrigues earned a BS in Chemical Engineering at the U.C. Berkeley and a PhD in Chemical Engineering at the University of Wisconsin.
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 |