Equipment and Processing Report-12-21-2011
Increasing Dwell Time without Decreasing Output
December 21st 2011We have several tablet formulations that are dwell-sensitive-they require more time under compression than other formulations. Given increasing demand, we do not have the luxury of slowing the tablet presses down in an effort to increase that dwell time. How can we maximize dwell time and maintain or increase output in our tablet presses?
Equipment Design and Appropriate Procedures Improve Cleaning
December 21st 2011Sterilization or sanitization is usually applied to kill bacteria in a system. Equipment is cleaned to remove residues from the previous batch of product, and subsequently flushed to remove the cleaning liquids. To ensure that sterilization and cleaning are efficient and safe, it is not enough to develop the appropriate procedures. Selecting the right manufacturing equipment further improves cost efficiency, as well as patient safety.
Moving from a Reactive to a Systemic Approach to Manage Risk
December 21st 2011Risk assessment is not a new concept to the pharmaceutical industry, but lately the phrase has become a mantra. A systemic, science-based way to manage risk is becoming essential to meeting the spirit and letter of FDA requirements.
