This certificate documents the assessment of your instrument against the requirements stipulated in the JP General Chapter 9.62 requirements for repeatability and accuracy and the required acceptance criteria.
Please find details below on how to read the certificate page by page and to gain further insights into the testing that will be conducted.
As per the Pharmacopoeia General Chapters, calibration is mandatory and needs to be recorded in a calibration certificate, along with the measurement uncertainty.
Our Accuracy Calibration Certificate (ACC) does that by quantifying the accuracy (measurement uncertainty) of a weighing device over the entire weighing range.
This certificate documents the assessment of your instrument against the requirements stipulated in the Pharmacopoeia requirements (0.10%) for repeatability and accuracy including a pass/fail statement.
1 | This document refers to the applicable Pharmacopoeia, which in this case is JP 9.62. Additionally, procedures for the General Chapters Ph. Eur. 2.1.7.1 and USP 41 are also available.
2 | As-found and as-left: The Pharmacopoeia certificate includes the assessment before (as-found) and after (as-left) any maintenance, adjustment, or repair, according to the requirements highlighted in the various Pharmacopoeia chapters.
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As-found is important to determine if the validity of previous measurements of the user has been adversely affected. As-left takes into account any adjustments made during maintenance.
3 | Do you know what your recommended test frequency is? If you need help defining your ideal calibration frequency, GWP® Verification can help.
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4 | This is the main result of the Pharmacopoeia Certificate: summarizes the outcome of the stipulated Accuracy and Repeatability assessment according to the acceptance criteria of 0.10% (as-found and as-left), along with the corresponding pass/fail statement.
5 | Repeatability tests assess the ability of the instrument to provide the same results for the same weight applied several times – or how far these results deviate from each other.
6 | “d” stands for readability, also known as the smallest measurement increment a device can display. For example, if the readability is 1 g, then 1d = 1 g; 2d = 2 g, etc.
7 | Accuracy is how close the measurement value is to the true value.
8 | Sensitivity error describes the offset between the device indication and a reference weight at the nominal capacity of the device. Usually, this error is by far the most dominant systematic error for balances and determines the accuracy of a device / contributes to a device’s measurement uncertainty.
9 | Traceability in calibration is the ability to trace the calibration results to a known reference standard.
10 | Identification of the weights that were used to perform the calibration by means of the calibration certificate ID traceability to the SI is established.
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