PH- JR
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DATA MMTECHNOLOGIES < i)V;- >■!,. *,^ Solving the challenge of particle coating In the past two decades, functional coating of small particles such as granules, pellets and mini-tablets has become an integral part of pharmaceutical development and production. However, the coating process introduced challenges concerning IPC and weight gain. Researchers typically work with theoretically calculated weight gain as well as “trial and error” experiments, supported by PSD measurements. The traditional solution to this challenge derived from the tablet coating process, where tablets are usually counted in batches of 100 tablets, with repeated weighing during the process. The calculated average weight of one tablet shows when the target weight gain is reached. But when particles had to be counted, the same procedure was impossible to follow due to the need to count thousands of particles. The innovative solution to this problem came from DATA’s Pellet Counter, which allows users to count large amounts of particles. DATA COUNT PH-JR FEATURES • Accuracy: 99.5% - 99.9% (depending on size and shape) • Size range: 0.2mm - 3mm • Can count an unlimited number of objects • Can count pellets, granules and mini tablets • Machine weight: 5Kg • Bowl feeder maximum weight: 50 gr • Electricity: 110v or 220v • Environmental conditions: Indoor use only • CE certification PELLETS/BEADS COATING PROCESS IPC in-process control test Counting Back to line what clients say: ‘leva has purchased the PH-JR counting machine for R&D purpose, we are using it for the last 4 years for counting beads (pellets) which are relatively small objects used in pharmaceutical industry. It is highly recommended for counting small particles in the same weight & size, which are undergoing the coating process” Gabriel Welber, Senior Project Manager, Global Generic R&D, Teva Checking the metrical growth Calculating the single pellet/bead weight Counting - release test Defining the efficiency of the spraying proc

THE CHALLENGE Production of pellet layers Drug coat layer Enteric coat layer Small scale Pass in analytical examination Large scale Fail in analytical examination (e.g. reduction in drug release rates) Effecting factors - Product temp - Flow rate - Curing time Divergence in coalescence of polymer particles. - Pellets are ground during process - Lower solids from dispersion are attached to pellet Variance in surface area. Pellets are enlarged during the coating process. Consistent pharmaceutical processes and manufacturing units are needed to ensure homogenous pellet sizes. IN-PROCESS...

Homogeneity in Small vs. Large Scale During scale-up, spraying conditions and temperature regime can be adjusted to correspond to the increasing production volume. By using the pellet counter it is now possible to: a. Identify variations between small scales and scaled-up batches b. Ensure homogeneity in pellet size production at the end of every stage Weight gain of pellet (%) Actual quantity of solution sprayed (%) Theoretical weight gain of pellet (%) Actual weight gain of pellet (%) Ensure Homogeneity in PARTICLE size production at the end of every stage In multilayer coating, DATA’s...

When Speed & Accuracy Count DATA Detection Technologies Ltd. 14 Hartom st. (RAD bld), PO Box 45200, Har Hotzvim, Jerusalem 9777514, ISRAEL Tel: +972-732204444 | info@data-technologies.com | www.data-technologies.com