Massimo Crudeli
Process tolerance in regulated industries, such as pharmaceutical and biotechnology, is extremely strict. Weighing and dispensing is a critical part of a complex manufacturing process because it can heavily influence the quality of the final product.
The weighed quantity must comply with a predefined process tolerance. Equipment used to weigh such quantities must be qualified and validated before usage to guarantee an accurate and precise measurement. As a general rule, the calibration tolerance of the scale should always be tighter than the process tolerance.
Calibration aims at verifying that the device under test measures mass accurately over its operating range. The calibration of measuring, weighing, and recording equipment is a requirement in many industries, especially when you need to comply with legal limits.
According to U.S. Food and Drug Administration (FDA) 21 CFR Part 211, Sec. 211.68, 'Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.'
Similar statements can be identified in International Organization for Standardization (ISO) specifications and good manufacturing practice (GMP) regulations.
How to Ensure Your Instrument Fulfills Calibration Tolerance Requirements
A calibration test should be performed whenever the weighing equipment is first installed. However, the performance of a scale may change over time because of wear and tear or accidents. To ensure the instrument is continuously fulfilling the requirements for calibration tolerances—and for process tolerances—you must implement a monitoring strategy and define a regular calibration plan. Operators must conduct routine tests to assess the instrument’s suitability for daily application.
According to regularity requirements, pharmaceuticals, and biotech industries need to adhere to three critical needs regarding scale calibration:
- The equipment shall be routinely calibrated and checked at specified intervals
- Calibration shall be conducted according to a written procedure
- Records of the calibrations shall be maintained
Luckily, you can satisfy all of them using the STAEDEAN Life Sciences Weighing and Dispensing solution.
How Does STAEDEAN Life Sciences Weighing & Dispensing Solution Help?
The STAEDEAN Life Sciences Weighing & Dispensing solution allows you to interface your scales with your enterprise resource planning (ERP) system to manage calibration and verification tasks to verify the accuracy of instruments used for weighing the materials. It prevents you from using instruments that are not compliant with the specifications.
You can manually create instrument control tasks when needed, or they can be automatically enforced by the system based on a configured frequency. Different calibration tests can be defined as part of the control task.
If you do not calibrate your scale when required, you will not be able to use it for your weighing operations. This ensures that only calibrated instruments are used to weigh components.
Written instructions and procedures can be set up for each calibration test to support the operator during its execution. It is also possible to require an electronic signature and a second-person verification to complete the control.
Ultimately, you can print a report to maintain a record of all the calibrations and verification activities performed for each scale.
STAEDEAN Life Sciences Weighing and Dispensing solution allows you to run weighing operations most accurately and efficiently for your organization and industry regulations.
To learn how we can help you streamline your weighing and dispensing process
Massimo Crudeli