Clean-in-place design integration and cleaning chemical selection are vital components of every pharmaceutical manufacturing process; indeed, all pharmaceutical companies employ some type of cleaning application every day. As a result, FDA inspections of cleaning processes have been occurring with greater frequency in today's highly regulated manufacturing environment. To achieve effective and easily validated cleaning methods is to gain a thorough understanding of cleaning methods.
This course will provide a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residues.
Additional topics covered include a CIP technology review including examples of various pharmaceutical processes that illustrate how CIP technologies and hygienic design can improve cleanability. Other topics for discussion include CIP spray device selection criteria and dynamics of integrating CIP process piping into a pharmaceutical process.
A dynamic hands-on workshop will allow participants to work in groups to design, build, and implement a cleaning process for a pharmaceutical application. Participants will apply knowledge gained from the course to identify cleaning solutions to complex cleaning processes.
Quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, engineers, and all levels of management