ISO 8655 Standard Series: Pipette Calibration and Verification
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. The latest revision of ISO 8655 has ten parts, three more than the previous version, and includes stricter language about pipettes, maximum permissible errors, and user information. Pipette testing and calibration are addressed in Part 6, Part 7, and Part 8, with requirements for higher precision balances. Revised ISO 8655 aims to ensure reliable and reproducible pipetting accuracy in laboratories.
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 – as a system
- Related services
- Pipette calibration software
- Grade 3 lab water purification systems
- Training on pipetting skills
Our Solutions for Pipette Calibration
Discover the solution that meets your pipette calibration needs
Application Highlights
Volumetric Performance of Multi-Channel Pipettes
According to ISO 8655-6:2022, each channel shall be regarded as a single-channel. The paragraph 8.4.a details how a multi-channel balance can be used to measure all channels in parallel, aspirating and dispensing at the same time, one row at a time, and analyzing the results of each channel individually.
Sartorius Speedcal mobile is a patented and unique pipette calibration system including up to 12 weighing systems to speed up precise and efficient calibration of pipettes up to 12 channels.
- Test 12 channels as described in ISO 8655:2022 Part 6 in approximately 10 minutes
- Choose from 4, 8 or 12-channel version with the option to upgrade later
- Readability of 0.01 mg to check pipettes from 0.5 µl
Cubis® MPS for Single-Channel Pipette Calibration
To achieve professional pipette calibration according to ISO 8655-6:2022, the balance used for testing pipettes, burettes, dispensers or syringes shall be chosen according to minimum requirements, depending on the nominal volume of the apparatus under test. (see FAQ). In order to minimize the error due to evaporation, paragraph 7.3 specifies that the geometry of the weighing vessel should be considered.
Sartorius Cubis® MPS has been exclusively designed for pipette calibration, to reach the fastest stabilization times and the most ergonomic handling. Cubis® MPS features a draft shield with a motion sensor that opens automatically upon detecting the user, and closes automatically when the pipette is removed. This allows the user to focus on proper pipette handling.
- Scale interval up to 1 µg to check pipettes below 20 µl
- Integrated evaporation trap and humidity sensor
- Draft shield with automatic door opening and closing, on user movement detection
White Paper: How to Perform a Norm Compliant Calibration or Test
Evaporation Kit for Cubis® II Ultra-High Resolution Balances
With the recent update of ISO 8655, the calibration of pipettes requires balances of higher resolution with respect to the pipettes nominal volume. The new Pipette Calibration Kit YCP07MC includes an evaporation trap and 21 mL liquid reservoirs for Cubis® II Ultra-High Resolution Balances to keep the error due to evaporation as small as possible, without the need of an internal draft shield. It’s particularly recommended for small volumes <50 µL.
Services for Pipetting and Dispensing Products
In most laboratories, liquid handling products are utilized daily to prepare samples, controls, and assay reagents. Given that mechanical and electronic pipettes, as well as dispensers, are involved in almost every experiment, precision is of utmost importance.
Sartorius offers certified and accredited services to ensure the accuracy of your laboratory results and the dependability of your pipetting devices. Our services can be conducted on-site or at one of our Sartorius calibration laboratories. We also provide services for devices from other pipette manufacturers.
Sartorius’ services guarantee:
- Audit security and regulatory compliance
- Optimized device performance
- Consistent, reliable, and reproducible pipetting and dispensing results
Article: Insights from Service Experts in ISO 8655:2022 Revision
Compliant Reporting of Calibration Results and Fleet Management
The management of your pipette fleet with as-found and as-left calibrations requires the accuracy and precision values to be adapted to the nominal volume of the pipette, its environment or the number of channels. ISO 8655-6 paragraph 10 describes minimal information to be reported. The results of each test or calibration shall be reported accurately, unambiguously, and objectively.
Ingenix Pipette Advanced Calibration Module is the ideal software for service providers or for industries wishing to bring pipette calibration in-house.
- Pipette calibration compliant to ISO 8655:2022, 21CFR part 11 and EMA annex11
- Supports 3rd-party balances
- Supports pipette fleet management and test cycle guidance
Guide: Effectively Perform and Manage ISO-Compliant Pipette Calibration
Test Liquid as Specified in ISO 3696
The ISO 8655-6 standard, paragraph 6, requires the use of distilled or deionized water conforming to grade 3 or better as specified in ISO 3696:1987 as test liquid.
The Arium® Advance EDI consistently provides high-quality Type 2 deionized water. Its triple-stage purification efficiently eliminates tap water impurities and contaminants.
- User-Friendly: easy-to-operate touch display and clear menu
- Eco-Conscious: Access the needed Grade 2 water on-site, reducing reliance on single-use water bottles
- Customizable: Offers a range of configurations, including the Arium® Smart Station and various Arium® Bagtank sizes for water storage
Best Practices for Competent Use of POVA
In February 2024, ISO 8655 expanded with the addition of Part 10, providing detailed guidance on selecting Piston-Operated Volumetric Apparatus (POVA) and mastering pipetting techniques. This new section, ISO 8655-10, thoroughly outlines best practices for handling based on POVA type, liquid characteristics, pipetting methods, and other factors.
Gain essential pipetting skills, including correct techniques, maintenance, calibration, and ergonomic practices, through the high-quality training provided by the ISO 9001 certified Sartorius Pipetting Academy, ensuring laboratory personnel excel in their tasks and meet stringent quality standards.
Resources
Frequently Asked Questions
The balance used for testing shall be chosen according to the minimum requirements specified in the following table, depending on the nominal volume of the POVA under test.
Nominal volume of apparatus under test (V) | Resolution (d) mg | Repeatability (s) mg |
|---|---|---|
0,5 μl ≤ V < 20 μl | 0.001 | 0.006 |
20 μl ≤ V < 200 μl | 0.01 | 0.025 |
200 μl ≤ V ≤ 10 ml | 0.1 | 0.2 |
10 ml < V ≤ 1 000 ml | 1 | 2 |
1 000 ml < V ≤ 2 000 ml | 10 | 10 |
Sartorius Cubis II and MPS balances comply with these requirements.
Gravimetric Calibration and Testing of POVA According to Part 6 and 7 of the ISO 8655:2022
Calibration ensures pipettes dispense volumes accurately and precisely, adhering to GLP and ISO 8655 standards, and should match the specific pipette-tip combination used in the lab. Preventive maintenance involves cleaning, greasing, and part replacement to guarantee the pipette's longevity and reliable results.
ISO 8655 is an international standard that outlines requirements for pipette calibration, including environmental conditions, procedures, and equipment, ensuring reliable measurements. It provides guidelines for pipette characteristics, user and manufacturer responsibilities, and specifies testing equipment and procedures.
ISO 17025 is a standard that establishes the requirements for the competence of testing and calibration laboratories, ensuring the reliability and traceability of their measurements. Laboratories accredited to ISO 17025 undergo rigorous evaluations and annual audits, providing confidence in their calibration services and the accuracy of their issued certificates, which are recognized internationally through various accreditation bodies.
To establish a pipetting quality control program aligned with Good Laboratory Practice, create a Standard Operating Procedure (SOP) that includes:
- In-lab testing routine specifications, such as testing frequency, equipment, personnel qualifications, volumes to be tested, acceptance criteria, result documentation, and actions for non-compliant pipettes.
- Maintenance and calibration protocols, detailing requirements for the calibration lab (adhering to ISO 8655 and ISO 17025 for example), testing procedures, frequency, decontamination, documentation, and evaluation of pipette failures.
- Continuous education plans for lab personnel, covering training in correct pipetting techniques, quality systems, and standards, with documentation of their qualifications.
