Ensure the Highest Level of Pipette Accuracy

Improved Pipette Calibration and Testing Revisions in ISO 8655 advance laboratory excellence Table of Contents Maintaining Reliable Measurements in Laboratories 3 Five Things You Should Know about the New Pipette Calibration ISO 8655:2022 4 Sartorius Pipetting Academy 7 ISO 8655:2022 sets new Standards for Pipette Calibration and Quality Control 8 Pipette Calibration Solutions 11 3 Maintaining Reliable Measurements in Laboratories Navigating POVA Calibration with ISO 8655:2022 Precise volumetric measurements are the bedrock upon which reliable research and diagnostics rest. Piston-operated volumetric apparatus (POVA), including pipettes, burettes, and dispensers, play a pivotal role in these measurements, often determining the accuracy and reproducibility of experimental outcomes. Calibration and testing of these instruments are therefore not merely procedural steps but essential practices that ensure every drop or dose is measured with utmost accuracy. ISO 8655:2022, a revision in the standardization of POVA calibration and testing focuses on several critical enhancements that emphasize the integration of pipettes and tips as unified systems, demanding that manufacturers demonstrate their combined accuracy under specified conditions. Moreover, the introduction of alternative calibration methods, such as photometric measurement alongside traditional gravimetric techniques, provides laboratories with flexibility in calibration approaches. Stricter protocols for calibration, including multiple tip usage and comprehensive pre- and post-maintenance assessments, further underscore ISO 8655:2022's commitment to enhancing measurement reliability. For laboratories worldwide, adherence to ISO 8655:2022 isn't just about compliance; it's a strategic imperative for achieving and maintaining the highest standards of precision and reliability in volumetric measurements. By adopting these updated standards, laboratories can minimize measurement errors, enhance experimental reproducibility, and ensure consistency across research and clinical applications. 4 Five Things You Should Know about the New Pipette Calibration ISO 8655:2022 Pipettes feature in virtually every experiment and pipetting accuracy is extremely important Pipettes are used frequently to prepare samples, controls, and assay reagents in the research laboratory. The ISO 8655 is an international standard that introduces several changes to the calibration and testing requirements for pipettes and other piston-operated volumetric apparatus (POVA), like burettes, dilutors, dispensers, and syringes. These updates affect general users as well as labs that work in compliance, such as manufacturing or calibration labs. The new ISO 8655:2022 is composed of ten parts: • PART 1: Terminology, general requirements, and user recommendations • PART 2: Pipettes • PART 3: Burettes • PART 4: Dilutors • PART 5: Dispensers • PART 6: Gravimetric reference measurement procedure for the determination of volume • PART 7: Alternative measurement procedures for the determination of volume • PART 8: Photometric reference measurement procedure for the determination of volume • PART 9: Manually operated precision laboratory syringes • PART 10: User guidance, and requirements for competence, training, and POVA suitability Pipette testing, calibration, and errors Concerning pipettes, ISO 8655 specifies maximum permissible errors for pipettes, requirements for markings, and the information manufacturers must provide. “Part 2 includes air-displacement and positive displacement pipettes, multi-channel and single-channel variants,” explains Joni Åke, Product Manager at Sartorius. “Importantly, the new ISO always combines the tip and the instrument as one system.” Calibration sets the foundation for reliable and reproducible pipetting. Before the update, gravimetric measurement was the gold standard for calibration and testing. According to the new ISO 8655:2022, it’s ok to use either a gravimetric procedure (Part 6), or a photometric procedure (Part 8). 5 Part 7 addresses the strict environmental requirements for testing and calibration. “It is not always possible to fulfill these, especially when calibrating or testing on a customer site,” says Axel Taube, Service Product Manager at Sartorius. “Alternative measurement procedures described in Part 7 allow deviations from these requirements within defined limits, and alternative gravimetric measurements can also be performed according to Part 7 A.2.” You will need higher precision balances The new ISO has requirements on readability, repeatability, and the so-called “expanded uncertainty in use” for balances that are used for pipette calibration and testing. Per the new ISO 8655 standards, some labs may need to upgrade their balances. “A six-place balance is now needed for pipettes with nominal volumes smaller than 20 µL, and precision balances for volumes between 20 µL and 199 µL”, explains Axel. Further, measuring multi-channel pipettes in parallel is now specifically mentioned in the new ISO. To keep up with this, we recommend a balance with several weighing cells, such as the SpeedCal Calibration System by Sartorius that can calibrate multi-channel pipettes of up to 12 channels in parallel. Learn how Sartorius’ pipette calibration solutions can help you achieve compliance, efficiency, and lower costs. Read our ISO 8655:2022 FAQs for more in-depth information about the new standards. Pipette Tips It is recommended that the tip manufacturer proves that the system (PipetteTip combination) meets the requirements and maximum permissible errors of ISO 8655. ƒ Tips are single use – they shall not be cleaned and reused ƒ Attach the tip only once – it may be used for several replicates once it has been attached ƒ Multi-channel pipette tips have maximum tolerance for varying in spacing from their nominal axes – new limit for <100 µL volume pipette tips ISO 8655:2022 and the Pipette-Tip System Learn more at www.sartorius.com Tip Manufacturer Must Provide: 1. Manufacturer and model name of the pipette(s) for which the tips are proved to fulfill the requirements 2. Chemical compatibility and sterilization data 3. Nominal volume The Pipette and Tip Make One System ISO 8655:2022 states that a pipette and a tip are considered as one system. Every Pipette-Tip combination must be tested and shown to meet the requirements described in the standard. 1 Use Sartorius tips with Sartorius pipettes. Tip manufacturers do not always notify pipette producers about changes to their tips. For the most reliable performance, it is best to use Sartorius tips with Sartorius pipettes. Maximum permissible errors ISO 8655 standard specifies accuracy and precision limits as both absolute (μl) and relative (%) values. To work according to the standard, all instruments must meet the minimum performance limits. Limits (random and systematic errors) are given for 100%, 50%, and 10% of the nominal volume. Multi-channel pipettes have their own table - notice the different limits compared to single channel pipettes! Pipette Manufacturer Must Provide: 1. Usable volume range, basis of adjustment (Ex), and maximum permissible error limits 2. List of tips that can be used with the pipette 3. Suggested basis of routine testing 4. Information on care, cleaning, sterilization, and, upon request, chemical compatibility Electronic Pipettes Electronic motorized air displacement pipettes are considered in ISO 8655:2022 Part 2. ƒ Recognizes variety of operating modes ƒ Speed setting should be visible in the calibration certificate ƒ Method for testing multi-dispensing mode (in addition to pipetting mode) ISO 8655:2022 contains updated requirements for producing and in-use control of piston-operated volumetric apparatus (POVA), replacing the 1st edition from 2002. ISO 8655:2022 consists of nine parts in total. Here, we describe the main points about Part 2: Pipettes ISO 8655:2022 recognizes the mode and speed settings of electronic pipettes. Every Pipette-Tip combination must be tested and shown to meet the requirements and maximum permissible errors described in ISO 8655:2022. Webinar: Future-Proof your Lab Environment with Versatile Pipette Calibration Solutions Webinar: How Does the Revision of ISO 8655 Affect the Quality Control of My Pipettes? Blog: Five Things You Should Know about the New Pipette Calibration ISO 8655:2022 Infographic: Tips and Standards for Pipette Calibration with ISO8655 Whitepaper: Gravimetric Calibration and Testing of POVA acc. to Part 6 and 7 of ISO 8655: 2022 7 Sartorius Pipetting Academy ISO-certified training to enhance the quality of your work The Sartorius Pipetting Academy offers training and content aimed at not only beginners but also experienced lab professionals. The academy’s modules are a balance of theory and hands-on sessions, packed with tips and tricks to help you get the most out of your pipetting. ISO 9001-certified training program Pipetting Academy is an ISO 9001 certified training program, with high-quality training from certified Pipetting Academy trainers, and guarantees that laboratory personnel will be trained with the pipetting knowledge and skills necessary to master their tasks and meet quality requirements. What you will learn • The essentials of pipetting • Correct and safe pipetting techniques • Pipette maintenance and calibration procedures • Applying the best pipetting ergonomics for your daily work • Master pipetting for several demanding applications Sartorius Lab Academies The Sartorius Lab Academy is a training program for specialized lab personnel. The program offers seminars tailored to your daily lab tasks to teach you how to enhance the operation of your equipment to maximize its performance and to deal with management issues. Our courses offered are specially designed to meet your requirements. On request, we will hold our Lab Academy courses at your own company or laboratory. In this way, we can adapt our course content directly to accommodate your ambient conditions and lab procedures. Our course objective is to enhance the efficiency and productivity of your workflows. Join the ranks of our satisfied users who have done just that after completing our seminars. To learn more, download our Pipetting Academy Flyer, and join us! Attendee from Biopharma Company, USA Even though I’ve been using pipettes for many years, I learned something new. Great refresher course. Attendee from Pharma Company, France The training was complete, clear and fun, which suited us perfectly. 8 ISO 8655:2022 sets new Standards for Pipette Calibration and Quality Control ISO 8655 revisions set the pace for laboratory practices including manufacturing, calibration, and the use of piston-operated volumetric apparatuses In the meticulous world of laboratory science, precision and accuracy are paramount. Every drop, every measure, and every reading can significantly impact the outcomes of critical experiments and tests. ISO 8655:2022 is an international standard for calibrating and testing piston-operated volumetric apparatus (POVA), including pipettes, burettes, dilutors, and dispensers. ISO 8655:2022 goes beyond merely setting benchmarks; it lays out a detailed roadmap for calibration procedures, specifying the types of equipment needed, ideal environmental conditions, and robust methods for performance assessment. It defines the accuracy and precision limits for various POVA types, ensuring that measurement results are not just reliable but also reproducible across different settings. In industries where every measurement counts—such as pharmaceuticals, biotechnology, and clinical diagnostics—adhering to these standards is crucial. It minimizes errors, enhances the reproducibility of experiments, and ensures compliance with stringent regulatory requirements. Here, we delve into the intricacies of ISO 8655:2022, exploring how it underpins the reliability and accuracy of volumetric measurements in laboratories, and why its implementation is indispensable for calibration and quality control in laboratories. Enhancing accuracy and reliability of POVA The 2022 revision of ISO 8655 introduces several significant changes aimed at enhancing the accuracy and reliability of POVA. ISO 8655:2022 encompasses various types of piston-operated volumetric apparatuses, including pipettes, burettes, dilutors, and dispensers. The standard is divided into nine parts, covering terminology, specific requirements for different devices, and testing methods. Notably, the new revision emphasizes micropipettes, providing guidelines for manufacturers, calibration laboratories, and end-users. One of the most substantial changes is the integration of pipette and tip systems. Manufacturers must now demonstrate that their pipette and tip combinations meet the specified maximum permissible errors, ensuring that variations in tip manufacturing do not affect the accuracy and reliability of pipetting results. The revised standard also mandates stricter calibration protocols, including the use of at least two tips per calibrated volume. This helps identify variations in dispensing due to tip quality. Additionally, the new standard requires an "as found" and "as left" calibration before and after any maintenance or repair to ensure ongoing accuracy. Another important update is the introduction of photometric measurement as a valid 9 alternative to the traditional gravimetric method for pipette calibration. This gives laboratories more flexibility in choosing calibration techniques. Part seven of the new ISO describes alternative measurement procedures, allowing some deviations from strict environmental conditions. These alternatives are particularly useful for calibrations conducted in typical laboratory settings where perfect conditions might not be feasible. Key Changes in the Revised Standard 1. Introduction of New Calibration Procedures: The revised ISO 8655:2022 introduces two reference measurement procedures: gravimetric and photometric. Previously, only the gravimetric method was recognized. The photometric method now holds equal status, offering an alternative for calibration depending on specific needs and conditions. Additionally, Part Seven outlines alternative measurement procedures that allow deviations from strict environmental requirements, provided they are within defined limits. 2. Environmental Conditions for Calibration: The updated standard specifies stricter environmental conditions for calibration using reference procedures. Factors such as air temperature, humidity, air pressure, and liquid temperature significantly affect calibration results. For example, increased air temperature can cause expansion in the air space between the seal and the liquid, reducing the pipetted volume. Similarly, changes in humidity and air pressure can alter the dispensed volume, emphasizing the need for controlled environments during calibration. 3. Enhanced Requirements for Pipette Tips: One of the notable changes is the stricter language regarding pipette tips. The revised standard mandates that tip manufacturers must prove that their tips meet the maximum permissible errors when used with specific pipettes. This includes accounting for variations in manufacturing. The standard now also requires manufacturers to provide detailed information on chemical compatibility and sterilization of tips, ensuring better compatibility and reliability. 4. Inclusion of Electronic Pipettes: ISO 8655:2022 now includes electronic pipettes, recognizing their different pipetting modes and the impact of speed settings on results. Calibration certificates must now indicate the speed setting used during testing. The standard also introduces a method for testing multi-dispensing modes, facilitating easier comparison of performance across different electronic pipettes. 5. Balance Requirements for Calibration: The new standard updates the requirements for balances used in calibration. For instance, a six-place balance is now required for calibrating pipettes with nominal volumes up to 20 microliters, an increase from the previous 10 microliters. Similarly, more precise balances are mandated for higher nominal volumes, ensuring greater accuracy in calibration. 6. User Guidance for POVA Selection and Best Practices for their Use: Newly created, part 10 emphasizes the importance of selecting appropriate POVA and pipette types, ensuring their use within safe liquid handling ranges for accuracy. It also discusses the pros and cons of various pipettes and tips and the effects of sterilization on pipette tips, and provides rules on pass/fail decision. Practical implications for pipette users and laboratories For pipette users and calibration laboratories, the 2022 revision of ISO 8655 brings several practical changes that enhance quality assurance, provide calibration flexibility, and improve device maintenance: Improved quality assurance By treating the pipette and tip as a single system and requiring proof of compatibility, the new standard enhances the reliability of pipetting results. Users can be more confident in the performance of their devices, knowing they meet stringent quality standards. Calibration flexibility The inclusion of photometric methods and alternative measurement procedures provides laboratories with more options for calibration. This flexibility can lead to more efficient and accessible calibration processes, especially in environments where traditional methods are challenging to implement. Enhanced testing protocols The requirement for multiple tips in calibration and the introduction of stringent environmental conditions for reference procedures mean that calibration laboratories must adopt more rigorous testing protocols. This shift ensures that pipettes consistently deliver accurate volumes, which is critical for scientific and medical applications. 10 Manufacturer transparency Manufacturers are now required to provide extensive information about their products, including calibration recommendations, cleaning and sterilization procedures, and chemical compatibility data. The requirement to validate pipette tips and provide detailed compatibility information ensures higher product reliability and customer trust. Additionally, the inclusion of electronic pipettes in the standard encourages manufacturers to innovate and improve their product offeringThis transparency helps users maintain their pipettes more effectively and ensures they follow best practices for device care. Adaptability to laboratory conditions The new ISO standard accommodates alternative measurement procedures that allow some deviations from strict environmental conditions. This adaptability is particularly useful for calibrations conducted in typical laboratory settings, where perfect conditions might not be feasible. For End-Users The revised ISO 8655:2022 aids end-users in procurement and usage of pipettes by ensuring that products meet stringent quality standards. Users benefit from clear guidelines on calibration protocols and maintenance, though the responsibility for establishing specific protocols remains with the pipette owner. The standard’s recognition of electronic pipettes and the inclusion of detailed tip compatibility information further enhance the usability and reliability of pipettes in laboratory settings Unified standards for enhanced accuracy The 2022 revision of the ISO 8655 series marks a significant advancement in the standardization of pipette calibration and testing. By focusing on the pipette and tip as a unified system, introducing alternative calibration methods, and enforcing stricter calibration requirements, the new standard enhances the accuracy and reliability of pipettes used in laboratories worldwide. These changes provide a robust framework for ensuring high-quality pipetting results, ultimately supporting better scientific and medical outcomes. Manufacturers, calibration laboratories, and end users must adapt to these new requirements to maintain compliance and ensure the highest levels of accuracy and reliability in their work. The ISO 8655:2022 revision is a critical step forward in the continuous improvement of laboratory practices and the pursuit of excellence in scientific research and diagnostics. For further information, visit sartorius.com Working with Sartorius The ISO 8655 standard is an international standard for the calibration and testing of pipettes and other piston-operated volumetric apparatus (POVA), such as burettes, dilutors, dispensers, and syringes. Whether you need a better understanding of the guidelines for in-house pipette calibration or for outsourcing services, it is important to know what these changes mean for you. Sartorius has decoded the standard and shares its expertise on the following topics: • Balances • Pipettes and tips • Related services • Pipette Calibration Software • Grade 3 Lab Water Systems For further information, contact an expert here. USA Sartorius Corporation 565 Johnson Avenue Bohemia, NY 11716 Phone +1 631 254 4249 Toll-free +1 800 635 2906 Germany Sartorius Lab Instruments GmbH & Co. KG Otto-Brenner-Strasse 20 37079 Goettingen Phone +49 551 308 0