Many processes in a biopharmaceutical lab depend on data from analytical balances. In regulated work, balances must be in compliance and create an audit trail.
Usually, these balances must meet the data integrity guidelines of more than one regulator around the world. In the United States, a biopharma balance must meet the US Food and Drug Administration’s 21 Part 11 requirements. In the European Union, the key guidelines for balances come from the EU Annex 11.
To meet these guidelines, the instrument should include features for managing users and their roles, electronic signatures, and safe data-transfer options for integration into software systems like a laboratory information management system (LIMS), or electronic notebook (ELN), explains Sebastian Weber, product manager, software solutions at Sartorius Lab Instruments. The user assignments allow records to be traced in an audit trail and limit users to the processes required in their work.
Weighing the options
An important feature for compliance is the ability to save and transfer data, which requires Wi-Fi capabilities or a hardware interface, such as Ethernet, RS-232, or USB. These interfaces that provide an analytical balance with communications capabilities that allow it to interact with other instruments in a lab. Plus, a balance’s software can ensure that it stays in compliance with the required guidelines, such as those from the FDA or EU.
Even selecting a balance based on its screen can simplify life in a lab. For example, John Viero, director of Cole-Parmer essentials, recommends a balance with a color capacitive touchscreen that can be used by gloved personnel. Otherwise, some users would need to remove gloves to interact with a balance, put gloves on to work with samples and, possibly, repeat that process all day.
In collecting data in a regulated environment, a balance must be prepared before every use. Weber points out that the preparation includes leveling, adjusting, and calibrating. To simplify some of that preparation, Viero suggests a digital balance with external calibration features. Some models also display and capture the uncertainty of every measurement.
Keep it compliant
An analytical balance needs maintenance to stay in compliance and create an accurate audit trail. In addition, only a regularly maintained and calibrated balance can perform optimally for a long time.
Part of being consistent in taking care of a balance means regularly reviewing the data that it collects. In such reviews, scientists can look for signs of malfunction or violations of data integrity.
Time is crucial to compliant weight measurements. “The correct time on the instrument is essential for a proper audit trail,” Weber explains. “Therefore, the time should be checked at least once a month.” That can be handled automatically by setting up a time synchronization through a connected network.
Beyond time, other features of a balance can also be checked automatically. In some balances, that includes an automatic check for leveling, adjustment, and calibration before every use. If a balance is out of specification, some software can even block weighing until the instrument is repaired or simply adjusted.
As one last bit of advice, Weber says, “never forget to clean the balance regularly.” It’s not the case that clean is compliant, but it never hurts.