Tablets & Capsules

TC0414

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15 dissolution tests in a row without a need for operator interaction. The photos in Figure 2 compare manual to automatic dissolution testing. Media preparation and delivery One system allows as many as five different media (including concentrates and media with surfactants) per Figure 2 Operator involvement required for manual and automatic dissolution testing Tablets & Capsules April 2014 27 It is in fact this "walk-away" time that operators seek in order to improve the productivity of their labs; it also frees them to perform more mission-critical activities, such as method development, process validation, data checks, and verification. Using automation to shorten the testing cycle in the lab has helped keep many companies competitive. With automation in both the R&D and qual- ity departments, companies can create seamless processes for method transfer and thereby reduce a product's time- to-market. Automation also reduces the potential for human error and simplifies the investigation process. That is an impor- tant benefit because deficient laboratory investigations are a major source of FDA warning letters. Automation in the lab also increases the quality of data significantly because each dissolution test is performed the same way, every time, making the data sets more precise. Furthermore, because every step is recorded in a secure database, there are fewer data entry errors, and test results are no longer operator-dependent. By reducing operator exposure to hazardous com- pounds, automation also improves safety. In addition, automation reduces ergonomic stress because it elimi- nates repetitive tasks, such as sampling and filtering. The alternatives are manual and semi-automatic testing. Figure 1 compares the level of operator involvement each of the three approaches requires. With manual testing the operators must execute every single process step before, during, and after testing. Obviously, this is the most technician-dependent approach. With semi-automatic testing, all the sequential steps of dissolution testing are executed reproducibly without user interaction until the post-run activities (i.e., auto-sampling or using online ultraviolet-visible (UV-Vis) spectroscopy for real-time analysis). Fully automated test- ing is just that, complete automation of the testing process, from media preparation through to the test, including end-cleaning, as well as preparation and execu- tion of a subsequent test of the same or different product. Some equipment enables lab personnel to run as many as Manual testing De-gas media. Fill vessels with media. Add tablets to media to start test. Take samples at defined time points. Filter samples. Clean apparatus. Automatic testing De-gas media. Fill vessels with media. Add tablets to media to start test. Take samples at defined time points. Filter samples. Clean apparatus. Figure 1 Operator involvement required for manual, semi-automatic, and fully automatic dissolution testing Assembly set-up Media preparation Dosage form introduction Sample withdrawal Filtering Sample analysis and reporting Cleaning Pre test Dissolution test Requires user presence and interaction (technician-dependent) Does not require user presence and interaction (technician-indendent) Post test Manual Semi automated Fully automated e-Whitkanackart_26-29_Masters 4/3/14 2:38 PM Page 27

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