Custom Equipment
IMPACT often develops custom equipment and test platforms
that are used to aid various process development and scale-up
activities. The following products, which are available
for purchase, are working examples of this capability.
Please contact us for any specific custom equipment needs.
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PD-ScaleTM Mixing Test Platform
The PD-Scale unit is a proprietary equipment and test platform with two or more mixing vessels that are designed to be proportionally equivalent in mixing power (P/V), L/D, etc., yet at different scales (e.g., 100ml and 1 liter). The platform can be used verify the mass transfer-limited nature of processes at different scales and allows the user to model, identify and map out regions of both acceptable and unacceptable mixing performance for various parameters such as mixing rate, L/D, feed rates, impeller types, etc. Once these operating limits are identified, and the governing parameters for mixing are established, results from the PD-ScaleTM testing can be used to safely and efficiently scale-up to pilot or production scale. To see a recent publication in Pharmaceutical Formulation & Quality about the use of a PD-ScaleTM test platform, click the more info link to the right.
Click here to view details.
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ST100-XP Syringeability Test System
The ST100-XP is a proprietary test platform that provides a qualification step to precisely measure the parameters needed for validation of parenteral drugs by determining a “syringeability” quotient. The translated data can display units of flow per unit force or flow per unit pressure. The system is controlled with a PLC, requiring minimal operator input, and data is recorded with a high speed datalogger which can be downloaded to a spreadsheet application for data reduction and presentation formatting.
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Small Volume Dissolution Tester
The Small Volume Dissolution Tester is used for real time monitoring of the dissolution rate of protein therapeutics. The unit consists of two syringes loaded onto the sample cell assembly, one syringe is filled with the test fluid, and the other is empty. An electro-pneumatic control box provides the gas pressure and timing sequence to the cylinders, which drive the syringes back and forth. As the test fluid passes from one syringe to another it imparts mixing to the fluid to insure a homogeneous composition. A laser diffraction probe head is located in the fluid path and is available for measuring the size distribution of particles in the test fluid.
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White Papers
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Centrifugation Report
Two leading experts in the field of bio-separations review solid-liquid separation technology and applications in the biopharmaceutical industry. For more details including abstract, table of contents, and list of tables and figures, click the more details link.
Click here to view details.
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