Control strategy and methods for continuous direct compression processes

• Published in: Asian journal of pharmceutical sciences 2021-03, Vol.16 (2), p.253-262
• Main Authors: Suzuki, Yasuhiro, Sugiyama, Hirokazu, Kano, Manabu, Shimono, Ryutaro, Shimada, Gosuke, Furukawa, Ryoichi, Mano, Eichi, Motoyama, Keiichi, Koide, Tatsuo, Matsui, Yasuhiro, Kurasaki, Kazuki, Takayama, Issei, Hikage, Shunin, Katori, Noriko, Kikuchi, Masahiko, Sakai, Hiroshi, Matsuda, Yoshihiro
• Format: Article
• Language: English
• Subjects: Continuous manufacturing; Loss in weight feeder; Original Research Paper; Process control; Regulatory science; Residence time distribution; Solid drug products
• ISSN: 1818-0876; 2221-285X
• DOI: 10.1016/j.ajps.2020.11.005

We presented a control strategy for tablet manufacturing processes based on continuous direct compression. The work was conducted by the experts of pharmaceutical companies, machine suppliers, academia, and regulatory authority in Japan. Among different items in the process, the component ratio and blended powder content were selected as the items requiring the control method specific to continuous manufacturing different from the conventional batch manufacturing. The control and management of the Loss in Weight (LIW) feeder were deemed the most important, and the Residence Time Distribution (RTD) model were regarded effective for setting the control range and for controlling of the LIW feeder. Based on these ideas, the concept of process control using RTD was summarized. The presented contents can serve as a solid fundament for adopting a new control method of continuous direct compression processes in and beyond the Japanese market. [Display omitted] Using the RTD model, the magnitude and length of acceptable variation of LIW feeder can be established from its impact on the CQA of Assay.