Pharma · USP & Ph. Eur.

Pharma-compliant calibration. Minimum weight included.

SimplyCal performs the tests according to the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.) directly within the calibration workflow — including automatic calculation of the smallest permissible sample weight for your weighing processes.

Relative measurement uncertaintyrequired process accuracyMinimum weightunsafevalid weighing range

The minimum weight results from the measurement uncertainty, the safety factor and the required process accuracy.

USP & Ph. Eur. tests integrated

Repeatability and accuracy are tested against the acceptance criteria of USP ‹41› and Ph. Eur. 2.1.7 — as a separate step in the guided calibration workflow, as soon as the balance has been set up accordingly.

  • Repeatability: 2 s / smallest net weight ≤ 0.10 % (s at least 0.41 d, optionally with safety factor for USP)
  • Accuracy: |deviation| / test load ≤ 0.05 % (optionally with accuracy factor)
  • Criteria according to USP ‹41› and Ph. Eur. 2.1.7

Process accuracy & minimum weight

From the uncertainty function U = m·load + b, the safety factor and the required process accuracy, SimplyCal calculates the smallest sample weight below which weighing can no longer be performed reliably.

  • Safety factor selectable from 0.5 to 10
  • Required process accuracy freely adjustable
  • Minimum weight calculated per component

Configured per balance

Tare load, the customer's smallest net weight and the safety factor are stored per customer balance and weighing range — the test adapts automatically.

  • Tare load & customer's smallest net weight per range
  • USP and Ph. Eur. can be activated separately
  • Test points in use with warning limit

Dedicated test reports

Dedicated report types are available for USP and Ph. Eur.; the templates are stored per balance type and number of ranges and filled automatically with the measurement data.

  • USP and Ph. Eur. test report as separate templates
  • Process accuracy as a printable chart
  • Graphical evaluation with deviation at 0 d
USP (chapters 41 / 1251)Ph. Eur.Minimum weightProcess accuracySafety factor 0.5–10

Related topics

Made for regulated weighing processes.

We will show you the USP/Ph. Eur. test and the minimum weight calculation using an example from your production.