Overview
ABSTRACT
Most users verify their balances without knowing whether they meet their needs. As standards and regulations evolve, they now require the user to demonstrate that their balances meet the criteria set. Demonstration is done by determining the minimum weight, which must be lower than the smallest net amount of material weighed on the balance. This article explains how to comply with the requirements of the main standards and how to determine the minimum weight yourself in order to select a balance that reliably meets the requirements.
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Denis LOUVEL: Market Development
INTRODUCTION
On a routine basis, many users weigh very small test samples. Typically, they use only 1-10% of a scale's weighing capacity. But it's in this area that measurement uncertainties are at their highest. It is common to weigh 2 to 20 mg to prepare a standard solution for liquid or gas chromatography analysis. The key question now is whether this quantity to be weighed is compatible with QA (Quality Assurance) requirements and balance performance.
Minimum weighing increases the certainty that whenever a scale user weighs more than the minimum weight, his measurements are within the tolerances required to ensure product quality.
This knowledge provides the certainty that the factory always produces products of consistent quality, or that the laboratory always carries out analyses of consistent quality. Quality established for the process with the right weighing instrument, not quality obtained with a lot of analysis and sorting of products that didn't meet specifications.
What's more, the user has the peace of mind of knowing that he can easily pass the next audit or inspection, because now he has the documentation to show that his instruments comply with the process requirements.
This article proposes a solution to this tricky question, based on a number of different situations.
As is customary in the industry, we use the term "kg" instead of "mass".
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KEYWORDS
calibration | Weighing | measurement uncertainty | balances
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Minimum weighing: its importance in an industrial analysis process
Bibliography
- (1) - SFSTP - Quand la pesée minimale prend des proportions énormes ou la pesée minimale et ses conséquences. - Revue STP Pharma Pratiques, volume 16, n° 1, janvier/février 2006.
Also in our database
Standardization and standards
- Quality management systems – Requirements - ISO 9001 - 2015
- Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais. - ISO/IEC 17025 - 2017
- Measurement management systems – Requirements for measurement processes and equipment. - ISO 10012 - 2003
- Détermination de l'incertitude de mesure pour les mesurages volumétriques effectués au moyen de la méthode gravimétrique....
Organizations
European Directorate for the Quality of Medicines & healthcare EDQM http://edqm.eu
- Balances - Pharmeuropa 32.1 - Projet de chapitre 2.1.7
- Balances - GC <41> - 2014
- Weighing...
United States Pharmacopeia USP http://www.usp.org
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