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Usp 41 chapter 4111/7/2022 ![]() A new General Chapter within the European Pharmacopoeia applicable for balances used for analytical purposes provides a good opportunity for reviewing and updating existing metrological concepts and quality management systems for weighing in the pharmaceutical industry. Infamous examples of outdated practices are the perception of calibration being a process of just putting one test load on the balance, or the daily balance check that lacks a sound metrological foundation. As one consequence, outdated strategies of controlling the quality of weighing results can be more easily removed and substituted by state-of-the-art weighing practices. Their application should steer the pharmaceutical industry towards building a risk-based quality management system for weighing applications, built on proven metrological concepts. New pharmaceutical regulations in conjunction with established weighing standards help closing this gap. #USP 41 CHAPTER 41 VERIFICATION#In the past, the industry has sometimes lacked a sound metrological understanding of weighing, specifically concerning the performance verification of weighing instruments that includes calibration and routine testing activities. This method involves weighing of the sample and diluent, resulting in concentration units of mg/g.Accurate weighing results are key for quality control and production processes within the pharmaceutical industry. Chapter 1251 also introduces " gravimetric dosing", a state-of-the-art weighing methodology for analytical standard and sample preparation.Performing the right tests at the right intervals ensures high-quality results and potentially saves time and money by eliminating unnecessary testing! Watch the video Three Key Things about the USP revisions on weighing. Instead, the type and frequency of testing should be based on the risk and process tolerance of the application. A daily balance check, typically performed in the pharmaceutical industry, is no longer mandatory. Chapter 1251 revisions focus on balance qualification and operation, including the importance of " minimum weight". #USP 41 CHAPTER 41 DOWNLOAD#Standard operating procedures for balance testing are available to download for free. The WhitePaper “Weighing According to US Pharmacopeia” explains the requirements in more detail. Repeatability and accuracy tests are defined, with acceptance limits and permissible test weights. A more demanding balance assessment is introduced. Chapter 41 states that accurate weighing must be performed using a calibrated balance.See webinar on Calibration and Qualification of Laboratory Instruments. 41 BALANCES (IRA ) is virtu-ally independent of sample mass within the balance’s ca-pacity, use of a small test weight, which may be difficult to handle, is not required. It provides information on installation and operational qualification (IQ/OQ), performance qualification and balance checks (routine testing), minimum weight and balance operation. ![]() USP General Chapter 1251 "Weighing on an Analytical Balance" is a guideline applicable to balances used in all analytical procedures. ![]() Weighing should be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy. ![]() ![]()
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