Consider a quality control laboratory that processes 10 to 20 samples per day and releases as many as 20 batches of life-saving vaccines and pharmaceuticals each month. According to FDA stipulations, analytical results from tests performed by these laboratories are used to ensure the safety, purity and effectiveness of these batches. Liquid handling equipment plays a very important role in measuring and analyzing drug samples to determine if they possess these desired properties.
Now, consider the consequences if this liquid delivery instrumentation operates out of specification for one day. One week. One month. How much uncertainty can laboratories legally tolerate? And, even more importantly, how much uncertainty should laboratories tolerate?
While there are federal regulations mandating that laboratories follow liquid delivery quality control processes, each organization has the flexibility to make scientifically valid decisions about methods for and frequency of equipment calibration. Due to the ambiguity of current regulations and the difficulty in keeping up with technological advancements, regulations are incomplete, and a variety of different guides and standards have been brought forward. This article is intended to help readers navigate current regulations, standards and guidance regarding sufficient calibration procedures, emphasizing the need for more stringent liquid delivery quality assurance.
Quality control laboratories routinely prepare samples for testing, producing results that are reviewed, compared to specifications and used to make decisions about whether manufactured products can be released to market. Each step in the QC process is likely to include one or more liquid handling processes. Although some of these steps, such as wash phases, do not rely on accurate volumes, many are highly quantitative.
Some examples of volume-dependent sample preparation processes include:
Errors in these and other liquid handling processes can impact the accuracy of key analytical parameters used to verify the safety, purity and efficacy of drug batches. Examples of quantitative analytical tests relying on liquid delivery include:
If any of these quality tests fail to produce correct results, one of two scenarios ensues. The first is needlessly delaying a good batch of pharmaceuticals. This leads to wasted time, wasted resources and wasted money. And if the biopharmaceutical is in an unstable form, keeping products in limbo for too long can ruin an entire batch.
The second alternative with perhaps even more dire consequences occurs when the quality control laboratory erroneously clears a bad batch for distribution. The results of this error culminate in the biggest fears of most pharmaceutical companies – product recalls, patient injuries and, needless to say, money down the drain.
Consider a manufacturing company that tests pipette performance every six months. After one such test, the company receives notification that one pipette (or several pipettes) failed. By the time the notification is received, one or more batches whose quality was tested with the faulty pipette have been released. If the product is on the market, this situation would generally require notification of the FDA and the development of a protocol for additional testing. The company would also be at risk of a product recall and potential liability if the drug has already been consumed.
In light of the severe consequences that can arise from improperly functioning liquid handling instrumentation, most would conclude that federal regulations must tightly govern equipment performance verification and quality control systems. Unfortunately, this is not the case. Although regulations do exist, they are very broad and open to interpretation, and most have not caught up with advancements in liquid handling technology.
For example, the FDA’s Food, Drug and Cosmetics Act of 1938 simply states that drugs must be safe, pure and effective, and that to achieve these goals, manufacturing processes must be controlled.
21 CFR 211, Code of Federal Regulations, sets forth Good Manufacturing Practices. Two sections of this ruling are relevant to liquid handling. Subpart D states that equipment used to manufacture drugs should “be routinely calibrated, inspected or checked.” Subpart I emphasizes laboratory controls and requires calibration of all instruments, including liquid handling devices, “at suitable intervals in accordance with an established written program.” It is left up to individual laboratories to define and defend their choices.
Laboratories are also required to follow standards set forth by the United States Pharmacopeia (USP). Unfortunately, USP has little to say about liquid handling. One general chapter, Chapter 31, deals with glass and plastic volumetric apparatus – specifically volumetric flasks, transfer pipettes, and burettes. The USP specifies accuracy requirements for these particular pieces of volumetric laboratory equipment, but has not yet issued guidelines about handheld manual or automatic pipettes, or fully automated liquid handling equipment.
It is evident that liquid handling processes advance more quickly than corresponding regulations.
For example, the transition from glass to handheld manual action pipettes created the need for new standards and the need for preventive maintenance polices in liquid delivery devices. Similarly, the present trend toward extremely low volumes and higher density formats (e.g., high density microtiter plates) has driven the need for new measurement/calibration methods as well as the need to select from and standardize the best of these new methods. Because regulations provide inadequate guidance for modern laboratories, independent organizations release standards and guidelines to improve industry operations and promote best practices.
Current Good Manufacturing Processes (cGMP) is an effort to continually improve FDA’s Good Manufacturing Practices, recognizing that static regulations cannot keep pace with the highly dynamic pharmaceutical industry, especially given the often lengthy regulation revision process. This initiative provides laboratories with current best practices to avoid the need to continually amend federal requirements. For the most up-to-date information, cGMP relies on input not only from FDA personnel but also from quality control experts from industry, academia, government and consumer groups as well as a host of independent regulatory bodies.
The International Society for Pharmaceutical Engineering (ISPE), whose mission is to train and educate pharmaceutical manufacturers, is one such organization contributing to cGMP. ISPE produces Good Automated Manufacturing Processes (GAMP®) Good Practice Guide: Calibration Management. This guide takes a structured approach to setting up a calibration management system that follows the validation life cycle and is oriented towards engineering process control. It has a heavy emphasis on criticality assessment and corrective actions, including documentation of non-conformance events. This guide does not have specific information on liquid handling, but since liquid handling is a frequent source of equipment non-conformance events, the principles here are worth noting, particularly in light of present FDA enforcement focus on Corrective and Preventive Actions.
Several other organizations issue recommendations, such as the former National Conference of Standards Laboratories (NCSL), now NCSL International, which issued Recommended Practice 6 (RP-6) to help biomedical and pharmaceutical laboratories establish effective calibration control systems. In many ways, RP-6 is a complement to GAMP. Written from a metrology and equipment management perspective, RP-6 emphasizes the “nuts and bolts,” such as calibration and measurement traceability, calibration history records and good labeling practices. The recommendations in RP-6 help laboratories move towards establishing calibration programs that are in compliance with 21 CFR 211.
The Association of Analytical Communities (AOAC), whose vision is “worldwide confidence in analytical results,” is another agency directing quality assurance initiatives. The organization’s standard entitled “Accreditation Criteria for Laboratories Performing Microbiological and Chemical Analyses in Foods, Feeds, and Pharmaceutical Testing” includes the full text of ISO 17025 (discussed below), with additional appended information to benefit the target laboratories. Appendix A establishes a minimum calibration frequency of every three months for “Volumetric Delivery Devices” (including mechanical action pipettes and mechanical burettes) and notes that “all data acquired on instruments that fail a parameter are suspect between the failing assessment date and the last successful calibration/verification date.” Laboratories subject to these requirements include those testing foods for international export or those bound by contract to their customers. In addition, FDA has adopted this particular AOAC extension to ISO 17025 in its own voluntary accreditation program that now includes a number of district laboratories and also the FDA regional laboratories in Jefferson, Arkansas and Bothell, Washington.
With a long history of importance and responsibility in the world of testing and metrology is the American Society for Testing and Materials (now ASTM International), which develops market-relevant standards on a global scale. ASTM International standard E1154 states that liquid delivery device calibration should be performed every three months with 10 data points, while a “quick check” verification should be performed every month with four data points. This standard is not required practice in the pharmaceutical industry but it does provide a point of reference for laboratories evaluating internal programs since it is one of the few standards that make specific recommendations for both frequency and number of data points in pipetting calibration.
Due to the globalization of the pharmaceutical industry, international organizations are emerging to provide border-spanning guidance to the vast number of companies operating in multiple countries. For example, the International Organization for Standardization (ISO) emerged as a key global guiding body for a range of industries, particularly laboratories. A non-governmental organization, this network identifies and adopts relevant standards that can improve practices and ensure quality in products and services. These standards are highly useful for international companies to coordinate laboratory operations and maintain consistent quality programs worldwide.
ISO 17025 presents general requirements for the competence of testing and calibration laboratories, and includes both quality system and technical requirements. This standard is silent on the particulars of liquid handling, but does state that all equipment that can contribute significant uncertainty must be calibrated using traceable means and with a stated uncertainty. For nearly all analytical methods, liquid handling undoubtedly falls into this equipment category. Also in ISO 17025 is the recommendation that standard calibration and check methods be used as they are more easily validated and less expensively defended in audits. A growing list of FDA laboratories are ISO 17025 accredited, including district and regional laboratories in Arkansas, California, Colorado, Pennsylvania and Washington, providing evidence of FDA’s support of this standard.
To provide further guidance to laboratories, ISO Technical Committee 48 released a seven part series, ISO 8655, defining accepted liquid delivery performance and calibration practices. Parts one through five define and specify minimum performance requirements for accuracy and precision in liquid handling, including details on accepted metrological requirements and maximum permissible error.
The next two sections of ISO 8655 provide guidance regarding accepted methods for verifying performance of liquid delivery devices. Part 6, released in 2002, discusses gravimetric calibration, which verifies liquid volumes by measuring weight on a balance.
Due to advancing technologies that overcome several limitations of gravimetry, such as susceptibility to evaporation errors, difficulty in verifying the performance of individual channels in multi-channel devices and the requirement of a temperature and humidity controlled environment for accurate results, ISO added Part 7 to its standard in 2005. Here, ISO formally approved photometry for assessment of liquid delivery equipment performance. Relying on known light absorption properties at specific wavelengths, photometric calibration can provide strong assurance of data integrity, quickly and conveniently.
Two specific variants of photometric calibration are highlighted by the standard: single-dye and dual dye. As its name implies, single-dye photometry measures light absorption in one colorimetric solution to verify volume. The dual-dye approach to calibration, called Ratiometric PhotometryTM, employs two highly characterized solutions to combat accuracy problems typically associated with single-dye absorbance measurements, and yields results with uncertainty of less than one percent for volumes as low as 0.1μL.
As the industry continues to change and laboratories are faced with new challenges and new solutions, it is likely that ISO will continue to advance its standards. Currently, for example, ISO 8655 is clearly applicable to handheld pipettes. When these standards were prepared, ISO’s focus did not extend to robotic pipettors, explaining the exclusion of these liquid handling devices. The scope of the committee now includes a broader range of laboratory equipment and is likely to move in one of two directions: write additional standards to guide calibration of automated liquid handlers or revise existing standards to include them. It is important to note that 8655 Part 7 does approve “vertical beam photometry,” which is very useful in verifying robotic pipettors that dispense to microtiter plates.
Laboratories are being heavily challenged to evaluate their processes from start to finish by the increasing number of regulations and standards and the industry-wide focus on quality control, evident in the FDA’s Quality System Inspection Technique (QSIT) initiative. This program emphasizes Corrective and Preventive Actions (CAPA), prodding laboratories to identify where problems are occurring or recurring and document corrective actions taken to improve these areas.
The high failure rate of liquid handling instrumentation is cause for concern, especially in light of this growing focus on quality and the drastic consequences of failure. Forward-looking laboratories are taking measures to verify accuracy and precision and maintain liquid handling quality control to facilitate compliance and produce quality products.
Organization | Standard Title | Description |
ISPE | GAMP® Good Practice Guide: Calibration Management | A structured approach to setting up a calibration management system that follows the validation life cycle, with emphasis on criticality assessment documentation of non-conformance and corrective actions. Does not have specific information on liquid handling. |
NCSLI | Recommended Practice 6: Calibration Control Systems for the Biomedical and Pharmaceutical Industry | Guidance for development of internal metrology and calibration programs in the biomedical and pharmaceutical industries. Recommends procedures to achieve and maintain desired levels of accuracy and quality. Does not specifically cover liquid handling. |
ISO | ISO 17025: General Requirements for the Competence of Testing and Calibration Laboratories | Calibrate using traceable equipment with stated uncertainty. Prefers standard calibration and check methods. No specific guidance on liquid handling in this document (see AOAC version). |
AOAC | Accreditation Criteria for Laboratories Performing Food Microbiological and Chemical Analyses in Foods, Feeds, and Pharmaceutical Testing | Includes the full text of ISO 17025, with additional specific requirements for calibration frequency of common laboratory equipment. Requires that pipettes be calibrated at least every three months. |
ASTM International | ASTM E 1154: Standard Specification for Piston- or Plunger-Operated Volumetric Apparatus | Provides general specifications and guidance for pipettes. Recommends pipette calibration every three months with 10 data points, and a quick check verification every month with four data points. |
ISO | ISO 8655-2: Piston-Operated Volumetric Apparatus, Part 2 – Piston Pipettes | Establishes minimum performance specifications (accuracy and precision) for handheld pipettes. Compliance with these specifications must be met for the pipette to carry the CE mark. |
ISO | ISO 8655-6: Piston-Operated Volumetric Apparatus, Part 6 – Gravimetric Methods for the Determination of Measurement Error | Describes gravimetric method for calibration and testing of pipettes. |
ISO | ISO 8655-7: Piston-Operated Volumetric Apparatus, Part 7 – Non-Gravimetric Methods for the Assessment of Equipment Performance | Describes photometric and titration methods for calibration and verification of pipettes. |
George Rodrigues, Ph.D., is Senior Scientific Manager at Artel, the global leader in liquid delivery quality assurance. Rodrigues is responsible for developing and delivering communications and consulting programs designed to maximize laboratory quality and productivity through science-based management of liquid delivery. Rodrigues is Artel’s chief representative to key commercial clients, government regulatory bodies and industry organizations. His speaking and teaching engagements, along with his publications, build awareness of the challenges and solutions for laboratories in maintaining data integrity and confidence in their testing protocols. He plays a key role in developing the manufacturing and quality assurance processes for Artel products and organizes programs to assist pharmaceutical, biotechnology and clinical laboratories in improving their liquid delivery quality assurance and analytical process control. Rodrigues earned his BS in Chemical Engineering at the U.C. Berkeley, and a PhD in Chemical Engineering at the University of Wisconsin.
Tanya is a sales manager at Artel, where she has held many roles in her 20 year tenure with the company, which have included R&D product development scientist, project manager, marketing product manager and northeast account manager. In her current role, she spends time leading her team of North American account managers in finding prospective customers with liquid delivery challenges in the lab and finding ways to improve quality.
Jim is the Artel Global Account Manager covering Northern California to western Canada. His background in lab automation and liquid handling has helped Jim identify Artel prospects in the biotech market, understand their needs, and grow Artel’s business.
Prior to Artel, Jim held roles in sales, sales management and marketing with leading biotechnology companies including Beckman, Molecular Dynamics, GeneMachines, Genetix and Biosero. Most recently, Jim sold lab automation systems for PAA including integrated platforms, robots and scheduling software.
Jim is thankful to work with a strong Artel west coast customer support team that is delivering the highest quality systems and services to west coast customers.
John is a Global Account Manager with Artel. His focus is on helping customers optimize their liquid handling operations to their productivity goals.
Prior to Artel, John was a Senior Scientist at Janssen (J&J) working on a variety of automated platforms across R&D and GxP environments, in both small and large molecule. For the last three years, John was Chief Business Development Officer at GeNovu, dedicated to delivering software solutions that improve lab automation processes.
John has used Artel technology for more than fifteen years, and with his deep understanding of automation and laboratory operations he is well positioned to help customers get the best possible performance out of their instrumentation and assays.
With over 25 years in the automated liquid handling and lab automation industry, Ramon is well versed with the hardware/software performance requirements needed by laboratories along with the importance of accurate and reproducible volume delivery to meet specific applications.
His years included time with Beckman Coulter, Hamilton and Atlantic Lab Equipment where he promoted and sold the Biomek FX, NX, Hamilton STAR family of liquid handlers and Tecan EVOs along with large scale, fully walk-away automated integrated solutions.
Ramon is looking forward to continuing his journey with Artel to help labs get the most out of their equipment investments.
Katrine Kelly is currently a Global Account Manager with Artel. With over 18 years at Artel in Technical Support Katrine applies her technical expertise to assist customers both pre- and post-sale to make the best decision for their application. She utilizes her knowledge of Artel products and services to deliver online product demos and trainings. Prior to becoming a Global Account Manager, she installed and validated Artel systems at customer sites and she worked with customers remotely to get their instruments and software working. Katrine also managed the warranty and preventive maintenance program for Artel. She has an extensive understanding of Artel’s products and applications.
Sarena is Artel’s renewal sales manager. She held many roles in her 10 years at Artel. She started as Artel’s west coast applications specialist/ field service and moved into sales account management for the west coast. Prior to working at Artel, she worked in an R&D lab and gained experience working with enzyme assays and laboratory automation. Her technical expertise has helped her understand the challenges her clients face and allowed her to with them to find a solution.
Age is the Global Accounts Manager for the Midwest, including Central and Easter Canada. Over the last 25+ years, he has worked in the Life Science Research and Clinical Diagnostic markets focused on automated liquid handling and assay optimization. Prior to Artel, his roles included Systems Engineering, Technical Support, Training, Applications Support, Sales, Account Management, and Sales Management. Whether they work at the lab bench, in operations, or in the board room, Age uses his range of experience to partner with his customers and drive towards mutual success.
Morgan is a Research and Development Scientist who has experience in the life science/biotechnology industry with a focus on biological applications. She works to address customer needs by designing and conducting experiments, and provides accessible, tailored solutions for customers. Morgan is trained and qualified to comply with the requirements of ISO/IEC 17025 and is part of the team that delivers the Artel Liquid Handling Service.
Coming soon.
Coming soon.
Keith is an expert in liquid handling performance management, providing customized services across a wide range of platforms, applications, liquid volumes, and liquid classes. As Senior Applications Scientist, Keith combines his extensive knowledge and experience with rigorous science in his work in liquid handling system performance research, customer education, and assay/method validation.
Dana is a professional life sciences application enthusiast, with extensive experience applying liquid handling automation in a variety of laboratories throughout North America. As a field Applications Specialist at Artel, Dana works directly with laboratories to solve complex liquid handling and process issues that are often critical to their productivity and compliance, and to the integrity of their test results.
Kaziya is a Laboratory Applications Scientist with nearly a decade of experience as a bench scientist. Kaziya understands the real-world challenges of the lab and applies her extensive scientific knowledge to assist customers in solving liquid handling process and assay issues that critically impact productivity and data integrity. Kaziya is trained and qualified to comply with the requirements of ISO/IEC 17025 and is part of the team that delivers both the Artel Liquid Handling Service and the ISO/IEC 17025 Accredited Calibration Service.
Nick is a Laboratory Applications Specialist with hands-on experience in genomics and immunoassay development. Having worked in the molecular diagnostics and instrumentation space, Nick understands the issues involved with taking a regulated product from research to the market and uses this experience to help find meaningful solutions for customers’ liquid handling challenges. He is qualified to comply with the requirements of ISO/IEC 17025 and is part of the team that delivers both the Artel Liquid Handling Service and the ISO/IEC 17025 Accredited Calibration Service.
Karlton is a Laboratory Applications Specialist with over a decade of experience at the bench. He knows first-hand both sides of the molecular diagnostics market, having run many clinical diagnostics tests as a medical technologist as well as being part of a molecular diagnostics instrument product launch team. Along the way he’s been involved in technologist training, liquid handling optimization, and assay development/validation. With all of this experience, Karlton truly understands the demands of clinical and pharmaceutical labs and uses this expertise to help Artel’s service customers with their liquid handling challenges.
Maureen Minimi is a Laboratory Applications Specialist and pipetting proficiency trainer with over ten years of experience in the life sciences industry. She has hands-on experience in the molecular diagnostics market, having run many clinical diagnostic tests as a Medical Technologist, as well as experience with validating assays on instrumentation, troubleshooting instrumentation and training customers on pipetting skills and optimizing their workflows. She is highly knowledgeable in Good Laboratory Practices and her technical training skills and focus on excellent customer service have made her an excellent resource for helping customers with their liquid handling challenges.
Kristi is an expert in laboratory quality control with a passion for streamlining and implementing new processes. When not in the field providing Artel’s Liquid Handling Services and ISO/IEC 17025 Accredited Liquid Handling System Calibrations, Kristi manages quality internally here at Artel. As the Laboratory Chemist Supervisor, she ensures the quality of manufacturing reagents, final inspection of the PCS and MVS systems and reagents, as well as calibration, maintenance, troubleshooting and repair of Artel’s own laboratory equipment.
Andre is an experienced laboratory technician in the medical, research and pharmaceutical industry. As an Applications Specialist, he provides support and service in the Canadian Market, providing solutions to liquid handling challenges, assay optimization, method standardization and regulatory guidance.
Kristi is an expert in laboratory quality control with a passion for streamlining and implementing new processes. When not in the field providing Artel’s Liquid Handling Services and ISO/IEC 17025 Accredited Liquid Handling System Calibrations, Kristi manages quality internally here at Artel. As the Laboratory Chemist Supervisor, she ensures the quality of manufacturing reagents, final inspection of the PCS and MVS systems and reagents, as well as calibration, maintenance, troubleshooting and repair of Artel’s own laboratory equipment.
Rachel brings an extensive knowledge of automated liquid handler calibration and volume verification to the Artel Liquid Handling Service team. As a Product Development Scientist on the R&D team at Artel, Rachel Parshley has managed important product enhancement projects, including the development of 100% DMSO solutions for use with the MVS. These experiences translate into a thorough proficiency with both MVS and automated liquid handlers.
Kerry brings her passion for best-in-class delivery to Key Global Accounts at Artel. By listening deeply to clients in Clinical Labs and understanding their liquid handling quality, compliance, productivity, and staffing challenges, she creates customized road maps for success for individual labs and enterprises. Her goal is to help you meet your goals, and she effectively serves clients in both the private sector and the US Government.
Mark has worked in Clinical Diagnostic for over 40 years and at Artel for over 25 of them. He started at Artel as a Manufacturer’s Representative and has transitioned to a Global Account Manager. In his current role he works with all international opportunities, represents Artel domestically (Maryland, Virginia, Washington, D.C., Delaware) and is a liaison for all distributors. He works in all markets including Clinical, Biopharmaceutical, Research, Government and Forensics to improve laboratory results through better liquid delivery.
Maureen Minimi is a Laboratory Applications Specialist and pipetting proficiency trainer with over ten years of experience in the life sciences industry. She has hands-on experience in the molecular diagnostics market, having run many clinical diagnostic tests as a Medical Technologist, as well as experience with validating assays on instrumentation, troubleshooting instrumentation and training customers on pipetting skills and optimizing their workflows. She is highly knowledgeable in Good Laboratory Practices and her technical training skills and focus on excellent customer service have made her an excellent resource for helping customers with their liquid handling challenges.
Maureen earned a B.S. in Molecular Biology, with a minor in Chemistry at Montclair University in New Jersey.
Ryan Murphy is a Technical Support and Training Specialist for the Technical Services team. His responsibilities include providing after-sales instrument and software support and conducting proficiency certification trainings for Artel’s customers. He is dedicated to providing prompt and focused service and support to ensure continued customer satisfaction.
Ryan earned a BS in Biological Sciences and Neuroscience and a PSM in Biotechnology at Florida Atlantic University.
Keith J. Albert, PhD, is a Senior Applications Scientist at Artel, and is responsible for automated liquid delivery system performance research, customer education and assay/method validation services. He has spent nearly nine years managing and working on an Artel service team at Merck Boston – communicating with their scientists about volume transfer performance for their various liquid handling platforms.
He applies his expertise and scientific knowledge – in pre- and post-sales support – to help laboratories optimize their liquid delivery processes and maintain compliance. He earned his BA in Chemistry at Colby College and his Ph.D. in Analytical Chemistry at Tufts University.
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 13 years. He is a technical expert contributing to the efforts of standards development committees of ISO, ASTM International, and CLSI.
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 ISO/IWA 15. 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.
Doreen Rumery, Director, Laboratory and Quality Control at Artel, is a certified Medical Laboratory Technologist and ASQ Certified Manager of Quality/Organizational Excellence with more than 30 years in the clinical laboratory and manufacturing industries.
Doreen oversees all laboratory activities at Artel, including technical operations, method validation, technician training and conformance with current regulatory standards.
Candie Gilman is a Education & Training Manager Specialist and is responsible for both the coordination and/or delivery of all customer training programs and the developer of the training content. She has over twenty years of experience in biotech technical support and technical product training, and has spent the last decade working side-by-side with customers to standardize and improve their pipetting technique.
Candie also supervises the Artel Customer Service team and is a certified Communico MAGIC Training Facilitator.
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.
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
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 |
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