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The cleaning of processing equipment and interconnecting piping systems is an essential process in pharmaceutical and biopharmaceutical manufacturing facilities. 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.

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.

Event Location

Zoom. A meeting invite with the link will be sent to all registrants prior to the event. Please ensure you have the app downloaded prior to the event.

Attendee Registration

If registration is cost prohibitive, please reach out to diego.legrand@ispecanada.org and entela.brahimi@ispecanada.org for possible alternatives to support with the registration cost.

Register before April 30th, 2021 to enter our giveaway!

Registration Category

ISPE Member
$10 + TAX

Non-Member
$20 + TAX

Speakers

John Hyde is Chairman and Founder of Hyde Engineering + Consulting, Inc., a firm of over 250 engineers and scientists, founded in 1993 and specializing in process engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical manufacturers. Hyde Engineering + Consulting, Inc. have operations in the United States, Europe, India and Singapore.

Event Poster


Event Sponsor

Hyde Engineering + Consulting
Website

Out of stock

Upgrading and Optimization of Clean-In-Place (CIP) Systems and Processes – May 11th, 2021

ATTENDEE REGISTRATION – Upgrading and Optimization of Clean-In-Place (CIP) Systems and Processes

$20.00