The Details of ISO 8655:2022 in Plain English

Understanding the Updated ISO 8655:2022 Standard for Life Science Labs

It's no secret pipettes and other liquid measuring tools are extremely crucial to laboratory teams in the life sciences. After all, the quality of your experimental data and product testing is largely dependent on the ability of your pipettes to dispense liquids accurately, precisely, and with reliable consistency. This is also why regulatory auditors require proof that dispensing tools are in good working order and meet ISO 8655 pipette calibration requirements.

The ISO 8655 standard recently changed, having been revised in 2022 to better address how volumetric measuring devices are calibrated and checked to create greater accuracy and consistency across the life sciences industry. The new version of the standard is called ISO 8655:2022.

Industry experts agree: the new standard is giving life science labs better direction and guidance in a way that will make volumetric measuring assets more reliable, more accurate, and better able to meet the quality assurance requirements they need to be both productive and extremely precise in their pharmaceutical and biotech applications.

What does this mean for laboratories in life sciences organizations that use, manufacture, or service these tools? That's what we're here to explain. In this blog post, you're going to learn what the recent changes to ISO 8655 are and how the updated standard will affect your life sciences laboratory operations.

Quick Recap: What Are ISO 8655's Applications in Life Sciences?

ISO 8655 is the standard within the International Organization for Standardization (ISO) database that pertains to piston-operated volumetric apparatus (POVA), which includes pipettes, burettes, dilutors, syringes, and other liquid dispensing tools critical to life sciences research and manufacturing.

It includes standardized guidelines and requirements for the operation, calibration, manufacturing, and maintenance of POVA tools. ISO 8655 pipette calibration is a subset within the ISO 17025 that only addresses liquid handling devices and is considered the gold standard for life sciences laboratories.

Laboratories that meet ISO 8655 compliance have demonstrated advanced expertise in liquid dispensing tools and their calibration which ensures they maintain the highest level of reliability and consistency when measuring liquids for critical applications like drug formulation, cell culture preparation, and analytical testing.

Not every life sciences lab needs to meet these strict standards, but many do. Examples of those that do include:

• Pharmaceutical quality control (QC) laboratories.
• Bioanalytical testing facilities.
• Cell and gene therapy manufacturing labs.
• POVA manufacturers serving the life sciences industry.
• Biologics manufacturers handling calibration services in-house.
• Pharmaceutical manufacturers that must adhere to good manufacturing practices (GMP).
• Clinical research facilities.
• Any life sciences lab whose clients or regulatory bodies require adherence to the ISO 8655 standard as a compliance obligation.

Explaining the Details of the ISO 8655:2022 Standard for Life Sciences Labs

So, what's really changed from the old standard to the new one? For starters, there are now nine parts to the standard, two more than the previous version. Let's explore each part to understand what matters most to life science laboratories.

ISO 8655-1: General Requirements

ISO 8665-1 denotes the terminology, general requirements, and user recommendations of the standard in entirety. It is applicable to pipettes, burettes, dilutors, dispensers, and manually operated precision laboratory syringes used throughout the pharmaceutical and biotech industries.

ISO 8655-2: Pipettes

The ISO 8655-2 section defines the following for pipettes commonly used in life sciences applications:

• Metrological requirements.
• Maximum permissible error limits.
• Marking requirements.
• What information pipette manufacturers must provide to users.

It includes definitions and specifications for multi- and single-channel pipettes, air-displacement pipettes, and positive displacement pipettes. One truly notable addition to the standard as it considers the pipette; the pipette and the tip are now combined as one system—critical for life sciences applications where tip selection can significantly impact results.

ISO 8665-3: Burettes

Piston burettes, primarily used for titration and other applications for timed or metered deliveries of liquid in pharmaceutical manufacturing, are the focus of ISO 8655-3. This section of the standard also defines error limitations, marking requirements, and manufacturer information to be included with a product and user information, similar to ISO 8655-2.

ISO 8655-4 and ISO 8655-5: Dilutors and Dispensers

These two sections of the standard cover the guidelines and specifications regarding dilutors and liquid dispensers frequently used in sample preparation in life sciences settings. As with ISO 8655:2022 parts 2 and 3, it outlines the specifications, tolerance, error limitations, and other asset specific considerations important for bioprocessing and analytical testing.

ISO 8655-6: Gravimetric Reference Measurement Procedure for the Determination of Volume

In simple terms, ISO 8655-6 defines the guidelines on how the accuracy of POVA tools using gravimetric measurements is to be assessed in life sciences environments. This section (as well as sections 7 and 8 discussed below) can be viewed as the real meat of the standard as it outlines the requirements that must be adhered to in the calibration of volumetric measuring instruments used in regulated life sciences applications.

Notable improvements in the standard found in ISO 8655-6 include:

• It is now required that a minimum of 10 measurements per volume must be made for at least three volumes, including at 100%, 50%, and 10% of the nominal volume, for every POVA device calibration—increasing statistical confidence critical for GMP/GLP environments.
• There must be at least one tip change during the process, reflecting real-world usage patterns in life sciences labs.
• Increase in environmental conditions monitoring, vital for regulated testing environments.
• Pipettes can be tested against performance specifications other than ISO, but they must be more stringent than the ISO standard—allowing alignment with specific pharma company standards.
• Better analytical balances are required, enhancing measurement accuracy for life sciences applications.

ISO 8655-7: Alternative Measurement Procedures for the Determination of Volume

A limitation of the original ISO 8655 standard was that it only allowed gravimetric measurements and specific environmental conditions for determining volume when calibrating POVA tools. However, in busy labs in life sciences settings, it's not always possible to create such strict environmental controls or to rely solely on gravimetric testing procedures.

The updated standard has addressed these limitations and provided alternatives in ISO 8655-7, giving life sciences labs more flexibility in their compliance approaches.

ISO 8655-8: Photometric Reference Measurement Procedure for the Determination of Volume

The requirements, guidelines, and limitations when using photometric measurements to evaluate and calibrate POVA instruments are outlined in ISO 8665-8. Another impactful change to the standard, as outlined in section 8, is that photometric measurements are an approved measurement method when determining the volume delivery accuracy of a POVA tool—particularly beneficial for life science labs that already use spectrophotometry for other applications.

This update means life sciences laboratories can also use photometric measurement techniques in order to comply with ISO 8655 pipette calibration in addition to gravimetric ones, potentially streamlining their calibration processes.

ISO 8655-9: Manually Operated Precision Laboratory Syringes

Manually operated laboratory syringes, widely used in bioprocessing and small-volume pharmaceutical applications, were previously excluded from the original standard. The new version has rectified that oversight by adding information and guidelines pertaining to this type of volumetric measuring device.

As with other parts that address different POVA tools, part 9 provides maximum permissible errors, design requirements, and terminology definitions specific for syringes used in life sciences applications.

6 Ways the New ISO 8655 Specifications Will Affect Life Sciences Labs Moving Forward

There are a lot of new and exciting changes in the updated ISO 8655:2022 standard that are helping make liquid measurement more accurate and consistent across life sciences laboratories worldwide. For those that rely on these measurements every day to produce reliable results for drug development, quality control, and manufacturing, these changes should be welcome, good news.

Six examples of how the new standard will improve life science operations are:

1. Increased Emphasis on User Training: One of the notable changes in the 2022 revision of ISO 8655 is the increased emphasis on user training. The standard now requires users to adhere to manufacturer instructions and to consider the pipette and pipette tip as a standalone system—critical for maintaining GLP/GMP compliance in life sciences environments.

2. Enhanced Calibration Procedures: The updated standard provides more detailed guidance on calibration procedures to ensure that POVA tools align with the manufacturer's guidelines and acceptance limits. The inclusion of more measurement methods will give life sciences labs greater flexibility when meeting the revised standard while maintaining compliance with their rigorous quality requirements.

3. Inclusion of Digital Pipettes: Digital pipettes have become more prevalent in life sciences laboratories. The 2022 revision of ISO 8655 now incorporates guidelines related to the use and calibration of digital pipettes, essential for modern pharmaceutical and biotech research applications.

4. Clarification on Maintenance and Cleaning: The revised standard offers clearer instructions on how users at every level should perform maintenance and cleaning tasks of piston-operated volumetric apparatus. This will help retain an asset's integrity and functionality for longer—particularly important in clean room and sterile manufacturing environments.

5. Allows for Two Measurement Procedures: Photometric measurement procedures are now considered equal to gravimetric measuring procedures for calibration and checking of POVA tools. The ISO 8655:2022 standard does not favor one over the other, giving life sciences labs more options that align with their existing workflows.

6. Broader Scope: The revised standard has a broader scope, covering more types of piston-operated volumetric apparatus common in life sciences applications. This ensures that a wider range of equipment adheres to the same high standards of accuracy and reliability necessary for critical pharmaceutical and biotech processes.

Simplify Adherence to ISO 8655 Requirements With MasterControl Asset Management Software Solutions

While the updated version of ISO 8655 will help make your liquid measuring assets perform better and create more reliable results for your life sciences applications, it will also require more data collection and management from laboratories.

Increased measurements numbers, stricter tolerances, improved environmental monitoring, and other factors will require life sciences labs to collect more data than before. As a result, teams will need to take a more thorough approach to managing asset data in their GxP environments.

MasterControl's advanced computerized maintenance management system (CMMS) software solution can help ease this burden and even streamline a life sciences lab's asset calibration and management program. Built by industry experts with over 30 years of pharmaceutical and laboratory experience, it's a solution that is designed specifically for highly regulated life sciences settings and can help you achieve ISO 8655 compliance while meeting other GMP/GLP standards.

To learn more about how MasterControl can help you meet the updated ISO 8655:2022 requirements for your laboratory, contact our team today.