Special QApps

Standard Preparation (QAPP001)

Standard Preparation

This application is used to prepare standards or buffer solutions of known concentration. During the task setup, for documentation purposes the system devices (balance, thermometer, density meter and printer) can be set. Furthermore, the permissible sample weight tolerances in percent and the mode for samples out of tolerances can be defined. If the sample weight is below or above the set tolerance, the user either a) cannot accept the weight value, or b) must enter the set password to take over the weight value, or c) can accept any value, even if the weight is out of tolerance.

Users with the role right to create or modify tasks have access to the application's sample management. The sample management offers a solvent, component and sample library that can be edited by this user group. Solvents are defined by name and density and components by name, molecular weight, and purity. Newly created solvents or components are added to the corresponding libraries and by combining a solvent and at least one component, as well as entering the desired final concentration, the composition for the standard solution can be defined and saved in the sample library. The target concentration can be selected as a weight unit per volume or molar concentration. For the preparation of mixed standards or buffers, up to 20 components can be selected for each sample.

The user without the right to create or change tasks may only prepare standard solutions from stored samples. The user selects a sample from the library and is guided through the process by the software. On the basis of the volume entered by the user, the software automatically calculates the quantities of components to be weighed in and provides direct visual feedback by means of a graphic tolerance bar as to whether or not the weight is within the specified tolerance. Based on the components weights measured by the balance, the software application calculates the amount of solvent required to achieve the desired target concentration. Finally, the effective added solvent weight is determined gravimetrically, converted to volume using the density, and using this value the effective final concentration of the standard solution is calculated.

Finally, the software application creates a comprehensive report that can be printed out in standard or GLP format including a list of the system devices used during the procedure. In addition, the application allows the printing of labels that can be attached to the used vessels.

Material No. QAPP001

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

Last update: coming soon

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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. Applied tolerances can either be user-defined or acc. to Pharmacopoeia.

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 final statistics for each measurement is saved by the software application Tablet Checker and can be used to create lot and shift statistics. For the shift statistics all results saved for a lot measured between a defined shift start and end time and for the lot statistic the result of selected measurements are summarized in one statistics. Users with the role right create task can finish lot statistics. All measured results for a lot are summarized in a report and can be printed for documentation.

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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Fogging Test

The application Fogging test measures the weight of semi-volatile organic compounds (SVOC) according to the procedure described in standard DIN EN ISO 75201 method B. High surface and interior temperatures cause the polymers, textiles and natural materials used in automotive interiors to outgas volatile and semi-volatile organic compounds (VOC and SVOC) at accelerated rate. The SVOCs can condense onto the cooler surface of the windshield potentially creating a visibility and safety problem for the driver. The purpose of the fogging test is to assist manufacturers of materials used in the interior of vehicles and the companies that use the products in identifying and developing products that outgas SVOCs at a reduced rate. The fogging test procedure as described in DIN EN ISO 75201 helps to recreate automotive interior outgassing in a timely, measurable and repeatable way. During the gravimetric test procedure the initial and back weight are measured. The amount of fogging condensate is determined by subtracting the initial weight from the back weight (Gj = G1 – G0) and the degree of divergence v% is calculated.

Material No. QAPP007

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

Last update: 30/09/2020

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Final Pharma Filling

This application is used to fill liquid products using peristaltic pumps. By means of the pump, the liquid is transferred from a reservoir into vessels or bags and the transferred weight is checked gravimetrically. The application can control and regulate Rotarus pumps from Hirschmann and the pump models 323Du, 530Du and 630Du from Watson-Marlow via a serial communication.

When filling products, product data and pump settings are stored in a product database. The start, fill and end speeds of the pump can be set product-specifically. In addition, a reverse run can optionally be defined to pump liquid back in the feeding hose so that this portion is not counted as fill weight. The filling process is repeated according to the set number of samples and the results are calculated automatically. The filling weight in each vessel or bag, the minimum, maximum and average filling weight, as well as the standard deviation are determined in the statistical evaluation and are stored batch-specific in the product database. In addition, for filled vessels or bags labels can be printed, including information such as sample number, filling weight and expiry date.

 Material No. QAPP008

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

Last update: 30/09/2020

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MYCAP CCX Cell Passaging

This application is for the aseptic transfer of media or inoculum between MYCAP CCX flasks using peristaltic pumps. By means of the pump, media or inoculum is transferred from a donor flask into a recipient flask and the amount transferred is checked gravimetrically. The application can control and regulate the pump models 323Du, 530Du and 630Du from Watson-Marlow via a serial communication.

To define an experiment, there is an administrator and a user menu in which various parameters are recorded. The most important parameters are information on the cell density in the donor flask and the desired cell density in the target flask, as well as information on the available and desired volume of the medium in the target flask. In addition, the pump speed for different process steps can be defined in rpm. All settings are stored in an experiment database. From the concentration and volume data, the application automatically calculates the target weight of the inoculum or medium to be transferred and controls the peristaltic pump accordingly. The pumping procedure includes an optional priming step of the tube, the rapid transfer of medium or inoculum to a defined percentage of the target weight and finally the running of the pump at slow speed until reaching the target weight. The process is repeated according to the number of flasks to be filled until all samples have been processed.

The results including the final volume and the effective final cell density are automatically calculated for each sample and can be documented by means of a printer connected to the balance. You can also optionally print labels with cell line information, lot number, passage number, cell density, and the volume to label the filled flasks.

Material No. QAPP009

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

Last update: 30/09/2020

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