Abstract

John M. Hyde, Chairman and Founder, Hyde Engineering + Consulting, Inc.

The cleaning of processing equipment and interconnecting piping systems is an essential process in pharmaceutical and biopharmaceutical manufacturing facilities. Cleaning is used to remove post-production and cleaning agent residues to acceptable levels prior to the production of the next batch or product to ensure that products are produced without risk of adulteration. Process equipment systems and their interconnecting piping are often cleaned through the utilization of automated Clean-In-Place (CIP) technologies. As with many technologies used in the manufacture of pharmaceutical products, current best practices for process equipment cleaning evolve over time, leading to opportunities for continuous improvement. This seminar will focus on concepts that support the upgrading and optimization CIP systems and processes for continuous improvement of cGMP operations with respect to cleaning.

The seminar will specifically address:

• Regulatory bases for current best cleaning practices.
• Value of the generation of lab and pilot scale cleaning design space data to support cleaning cycle development and cleaning process scale-up.
• Review of Cleaning Critical Control Parameters (CCCPs) and Critical Cleaning Quality Attributes (CCQAs) and their relevance to cleaning best practices.
• CIP system design strategies for highly efficient cleaning operations.
• Common sources of cleaning inefficiencies and Out-Of-Specification (OOS) results, and effective solutions for typical failure modes.
• Successful approaches to reducing cleaning cycle time and water usage.
• Development of an ongoing monitoring strategy and the application of statistical process control (SPC) tools in the real time assessment of cleaning process efficacy and stability.

Seminar materials will be presented in accordance with the agenda above to stimulate the Q&A that will follow and to provide common background and understanding to the attendees.