(465c) Continuous Manufacturing Traceability for Pharmaceutical Products

Continuous manufacturing has been receiving lots of attention in the pharmaceutical industry with the often repeated obstacle being batch traceability. By definition and inherent nature of a continuous system there is no batch to validate, so redefining traceability and validation techniques in an industry that is dominated by batch manufacturing diction is a necessity.

This work focuses on this solving this problem through the development of method for traceability that is applied to a direct compaction pharmaceutical line. The generalized method that is used can also be easily adapted to the various other continuous manufacturing configurations that may be used in pharmaceutical formulation processing.

Through the use of measured residence time distribution (RTD) of the various continuous processing equipment it is possible to trace any process upsets or disturbances through the entire manufacturing system. Furthermore, the development of proper sampling and analytical techniques are presented and demonstrated with experimental support which can serve to detect and correct any significant deviations and thus mitigating risks.