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DATA Count Pharma JR (PH-JR)

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DATA Count PH-JR, pellets counter, quickly and accurately counts pharmaceutical pellets and mini tablets as small as 0.2mm providing for the first time a much needed tool to drug developers and manufacturers that produces capsules containing pellets.

Capable of counting small pellets, pharmaceutical developers and manufacturers can now better control pellet production processes through both counting and weighing, thus measuring pellets homogeneity in terms of active and non-active material content.

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DATA Count Pharma JR (PH-JR)

  1. 1. 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. Solving the challenge of particle coating 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 Sampling Drying Back to line Re-Sampling Weighing Checking the metrical growth Calculating the single pellet/bead weight Defining the efficiency of the spraying process Counting Counting - release test What clients say: “Teva 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 DATA COUNT PH-JR
  2. 2. IN-PROCESS Control DATA’s Pellet Counter provides an excellent means of controlling the coating process and determining the weight gain, i.e. the weight at the end of the coating stage, by a simple weighing and counting of a few thousand particles. Changes in operation parameters (e.g. atomizing pressure, inlet temp and flow rate) can be adjusted by theoretical vs. actual weight gain of particles during the coating process. THE CHALLENGE 0 -2 3 8 12 18 23 28 33 20 40 60 80 100 Atomize pressure was increased from 2.5 to 3 bar Actual quantity of solution sprayed (%) Theoretical weight gain of pellet (%) Actual weight gain of pellet (%) Weightgainofpellet(%) Small scale Production of pellet layers Pass in analytical examination Drug coat layer - Product temp - Flow rate - Curing time - Pellets are ground during process - Lower solids from dispersion are attached to pellet Pellets are enlarged during the coating process. Consistent pharmaceutical processes and manufacturing units are needed to ensure homogenous pellet sizes. Divergence in coalescence of polymer particles. Variance in surface area. Effecting factors Outcome Sub coat layer Enteric coat layer Top coat layer Fail in analytical examination (e.g. reduction in drug release rates) Large scale
  3. 3. 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 0 0 10 20 30 40 50 60 20 40 60 80 100 Actual quantity of solution sprayed (%) Weightgainofpellet(%) 0 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 Pellet Counter measures each coating stage, enabling step-by-step weight gain control. As depicted in the graph below, the initial suglet weight, as well as the weight gain after each subsequent coating stage, can be measured. Individual pellet weight gain Sugar Drug layer 0.000 0.2000 0.4000 0.6000 0.800 1.000 1.200 Theoretical K-47726 (pilot bio II) K-47887 (glatt 30 sublot 1) K-47887 (glatt 1)
  4. 4. 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

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