Clean in Place Fundamentals

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Training

Level: Fundamental
Type: Classroom Training Course
ISPE CEUs: 1.3

Description

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 an 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.

Course Modules

• Cabinet Washers, COP & CIP Technologies
• CIP Design Considerations
• Spray Devices
• Integrating CIP into the Process
• Cleaning Agents
• Reference Materials

Take Back to Your Job

• Describe the cleaning mechanisms utilized in the pharmaceutical environment with emphasis on CIP and COP technologies
• Explain how to design or modify the process for proper cleaning
• Identify and select the correct cleaning chemistries for specific soils and residues
• Participate in a design workshop that will test your skills and knowledge in implementing cleaning technologies in a pharmaceutical process

Attendance Suggested For

• Quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, engineers, and all levels of management

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency elements Facilities and Equipment: Design and Construction / Installation and Production Systems: Production Control. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.