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56 April 2016 Tablets & Capsules Automated tablet testing can improve quality control while simul- taneously increasing productivity, boosting customer satisfaction, and easing regulatory compliance. It's a small but important piece of the wave of automation affecting the economics of pharmaceutical opera- tions worldwide. Correlation between tablet parameters Measuring the com- pression force at each tablet punch has become a standard feature of mod- ern tablet presses because it enables the press or its operator to take immedi- ate corrective action if there is a fault. Compression force readings also allow you to draw conclusions about the tablets—primarily weight, thickness, and hardness—yet they must still be tested to determine whether they really are within speci- fied limits. Only a combination of these three test results provides a basis for reliable quality control. Tablet hardness relates not only to disintegration time, but serves as an indicator of whether weight and thick- ness are correct. In other words, if tablet hardness is outside the tolerance (T) limit, then the weight or thickness (or both) could also be off. Whatever the case, one test result cannot inform the operator about how to adjust the process. Should compression force be increased? Die filling decreased? Only by testing all three parameters of sam- ple tablets is it possible to get the complete picture and plan appropriate corrective measures. Improving productivity at a contract manufacturer Contract manufacturing is a com- petitive business and to get a com- petitive edge, companies must offer high-quality products, minimize direct manufacturing costs, and pro- vide clients with concise and easy-to- understand test reports. In one case, a contract manufac- turer was operating 17 tablet press bays and making as many as 15 dif- ferent products daily, including dietary supplements and OTC prod- ucts. For a long time, the tablet press operators shared several manual tablet testers, and the quality control lab used the same model. Because of the large variety of formulations the company made, tablet specifications were not programmed or recorded on the compression floor. Rather, the tablets were sent off to the QC lab, which verified compliance using printed reports from the production department. Batches were then authorized for release or held. It was an inefficient process rife with oppor- tunities for transcription errors. As result, the contract manufac- turer replaced the manual testers with automated units, three dedi- cated to the production department and one to the QC lab. Each used a 12-tablet magazine feeder so that multiple samples from a wide variety of products and batches could be tested quickly and efficiently. No modification was made to the tablet presses, but the stack lights on the testers were programmed to signal when the instrument detected that a T limit had been exceeded. Thus alerted, the press operator could decide what corrective action, if any, was needed and prevent the press from making substandard products. This simple change improved both productivity and quality. It also reduced waste and the need to remake products. Additionally, all the test data was captured electronically, stored, and secured. The other benefits of automated testing included batch test reports that showed real-time results related to plausibility, T1, and T2 limits. Because the data was no longer con- fusing, batch-release authorizations kept pace with production. Customers received test data by email just hours after their products were made. Delivery times became shorter and direct labor costs decreased. Future of automated testing As the pharma market continues to consolidate and cost pressures increase, manufacturers are adopting automation to improve quality and cost efficiency. Another trend is holis- tic product development in which companies think beyond formulation and marketing to plan better methods of production and quality control. This means using alternative tech- nologies like automated NIR spec- troscopy, something that almost all international pharma companies are pursuing. In fact, there are several suc- cessful PAT projects that incorporate real-time release using automated technology. This opens up new possi- bilities for automated tablet testing and will offer manufacturers signifi- cant cost savings. T&C Kevin Whitkanack is director of sales and marketing at Sotax, 2400 Computer Drive, We s t b o r o u g h , M A 01581. Tel. 508 417 1112. Website: www.sotax.com. b a c k p a g e Automated tablet testing With automatic testing, batch-release authorizations keep pace with production.