AUS-based pharma multinational company improved tablet coating efficiency by reducing the long process time and optimizing the coating process with the help of ACG without affecting product quality. Headquartered in Mumbai, ACG offers integrated manufacturing solutions for the pharmaceutical industry. The company has presence in over 100 countries.
ACG provides manufacturing solutions like empty hard pharmaceutical capsules, encapsulation machinery, tablet-coating systems, tablet-compression systems, fluid bed equipment, tablet tooling and performance enhancers and inspection systems.
Tablet film coating is an important unit operation in tablet manufacturing. A poorly developed film coating process not only ruins the aesthetics of the final tablet but may also cause various tablet defects, such as chipping, erosion, twining, color variation and poor solubility and stability. ACG, through its process improvement program, has helped its customers to optimize the coating process of their product and significantly improve their output by increasing process efficiency.
Challenge
The US-based pharma company faced the challenge with the film coating process of one of its products, valacyclovir tablets. The coating process requires approximately 120-130 minutes, which was longer than the expected coating time. Moreover, the pharma company was aiming for a robust and optimized coating process that can achieve the target by 2% increase in coated tablet weight.
ACG solution
Optimization of a tablet coating operation requires consideration of several process parameters. Further, the optimized process needs to be validated through multiple trial batches to ensure that the selected process affords the same output under the same set of operating conditions. ACG’s team of process experts studied the coating process, which was conducted in an ACG’s SmartCoater 700 at the pharma company’s site, and identified an opportunity to improve productivity by optimizing the process parameters. Two of the most influential parameters, namely airflow and spray rate, were identified for optimization within the BMR specifications. The main objective of the project was to improve productivity along with the product quality enhancement during the process optimization.
Results
The optimization resulted in significant improvements in the tablet coating process. The change in air-flow and other parameters, including nozzle-to-bed distance, angle and position as well as pan RPM resulted in 45% increase in spray rate, thereby reducing spray time and overall coating cycle time by 40 minutes. In addition to increased productivity, enhanced process efficiency and improved surface finish were achieved to eliminate coating rejections.
Furthermore, these parameters were validated in three batches to freeze the parameters and create process recipe, enabling the process to run in automode without manual intervention. In conclusion, by partnering with ACG, the pharma company has not only developed a robust manufactured process for its product but also increased productivity.
ACG’s SmartCoater series of tablet coating systems constitutes a major part of comprehensive range of pharma manufacturing solutions that are being used in more than 100 countries. SmartCoater features a fully perforated design, smart airflow patteren and patented ACG X-One nozzle, to ensure over 95% process efficiency. It offers maximum flexibility in terms of batch sizes (ranging from 125 L to 1400 L) and an option for sugar coating.
