Special QApps

Special QApps:

Tablet Checker

This application is for average weight control of tablets and capsules according to Pharmacopoeia and includes an administrator and a user level. The administrator can define products (definition of weight, type, tolerances and ratings) or modify or delete stored products. All products are stored in a product database and can be accessed by the user if required.
The workflow provides a quick test option and testing of a stored product. The quick test option can be used to test products that were not previously saved. For the quick test, all product data must be entered before starting the test, while when selecting a stored product, all relevant settings can be loaded from the product database and tested according to the specified specifications.
The application offers different procedures for the test of tablets and capsules. To test tablets their weight is determined and whether this is within the defined tolerances. For capsules, first the empty capsule weight is determined or entered by the user and then the weight of filled capsules is measured. Again, there is a check to see if the total weight of the capsules is within acceptable tolerances.
In terms of tolerance consideration, the application offers three different modes:
1. Fixed tolerances (dynamic tolerance off). The permissible tolerances do not change during the measurement and each sample is evaluated based on the fixed limits
2. Tolerances calculated on the total mean value (dynamic tolerance on). The tolerances are applied to the calculated average of the weights of all samples at the end of all measurements
3. Tolerances calculated on the current mean value (dynamic tolerance on). The tolerances are recalculated after each measurement on the basis of the current mean value of the weighing values and the samples are evaluated

The application is using the following calculations:

Mean value: avg = initValue + (sumSampleweight / n)

Standard deviation: dev = sqrt ((n * sum2Sampleweight - sumSampeweight * sumSampleweight) / (n * (n-1))) | sum2Sampleweight = sum2Sampleweight + (addValue * addValue)

The software after each sample (except for mode from total mean) checks if:

current weight >= (nominal * 0.2)

current weight >= nominal * (plausibility / 100), +1 added to counter for OFP if sample is out of plausibility

If measured weight = within OFT1 no action, +1 added to counter for passed

If measured weight > OFT1 and < OFT2 show info screen for 1 second, +1 added to counter for OFT1

If measured weight > OFT2 show warning screen for 1 second, +1 added to counter for OFT2

Material No. QAPP002

Available languages: English, German, Chinese, French, Italian, Japanese, Korean, Russian, Spanish and Portuguese

Last update: 28/10/2019

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Pipette Check Advanced

The Pipette Check application is used for the simple and reliable testing of piston stroke pipettes with fixed or variable volume type A or D1. In the application, the pipette and climate data can be recorded, as well as the used measuring instruments and pipette tips documented. For 140 different Sartorius pipettes, templates are stored in the software, of which the data is automatically adopted after selection. Created pipettes and used measuring instruments are stored in a database. On base of the nominal volume specified for a pipette, the software automatically determines the permissible tolerances for the random and systematic error in accordance with DIN EN ISO 8655 and by the climate data temperature and barometric pressure determines the z factor used to convert the measured weight values into volume values.
There are two test methods available:

1. The "Quick check" is based on a number of 1 to 9 measurements, for pipettes with variable volume setting per volume range, and is used to quickly check a pipette.
2. The "according to ISO8655" method requires 10 measurements per volume range to be tested
Depending on the selected test method, the software guides the user through the entire process. For visual support, a tolerance bar with the permitted tolerances is displayed to the user. The software immediately evaluates the measurement result after each measurement and produces a summary report after completion of all measurements. In addition, a bar chart is displayed for each measured volume, in which the number of measured values within and outside the tolerance is graphically displayed. The application uses the following calculations:
The z-factor is read from the z-factor table in DIN EN ISO 8655 on the basis of temperature and air pressure.
The permissible random (ran_diff) and systematic (sys_diff) measurement deviations are determined using the nominal volume of the pipette from the table with the permissible tolerances from DIN EN ISO 8655.
actual_lvl_vols = [All acquired volumes from ONE level]
nominal_lvl_vol = [Nominal volume of each level (10%, 50% or 100% of nominal_vol)]

actual_sys_diff = mean (actual_lvl_vols) - nominal_lvl_vol
actual_ran_diff = standardDeviation(actual_lvl_vols)

actual_sys_rel = (100 * (mean (actual_lvl_vols) - nominal_lvl_vol)) / nominal_vol
actual_ran_rel = (100 * (standardDeviation (actual_lvl_vols) / mean (actual_lvl_vols))) * (nominal_lvl_vol / nominal_vol)

A volume level (10, 50, 100)%* of a pipette is successfully tested (="OK"), if:

(actual_sys_diff <= target_sys_diff) & (actual_sys_diff >= (target_sys_diff * -1)) &
(actual_ran_diff <= target_ran_diff) & (actual_ran_diff >= (target_ran_diff * -1)) &
(actual_sys_rel <= target_sys_rel) & (actual_sys_rel >= (target_sys_rel * -1)) &
(actual_ran_rel <= target_ran_rel) & (actual_ran_rel >= (target_ran_rel * -1))

*For each level check the target differences and relativities (actual_sys_diff, actual_ran_diff, target_ran_rel & target_sys_rel) are the same from the "100%-level".

Material No. QAPP005

Available languages: English, German, Chinese, French, Italian, Japanese, Korean, Russian, Spanish and Portuguese

Last update: 28/10/2019

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