A focused introduction to the principles and practices of cleaning validation within the (bio)pharmaceutical industry, examining the design and validation of clean-in-place (CIP) and clean-out-of-place (COP) cleaning cycles for manufacturing equipment.
Aims and Objectives
The aim of this training is to provide participants with a foundational understanding of cleaning-validation principles, methods, and regulatory requirements in the (bio)pharmaceutical industry. Participants will learn why effective, thorough cleaning processes are validated, particularly in relation to the control and qualification of equipment used in the manufacture of highly regulated medicinal products.
Course Content
Contamination & potential sources of contamination
Manual Cleaning, Clean in place (CIP), Clean out of place (COP)
Cleaning Validation Approach “worst case product”
Dirty and Clean hold times
Visual Inspection & Coverage Testing
Direct sampling (swabs) vs Indirect Sampling (rinse samples)
Deviations during cleaning validation.
Introduction to P&IDs
Learning Outcomes
On completion of this programme the learner should be able to:
- Demonstrate an understanding the fundamental principles of cleaning validation and the industry’s regulatory requirements for compliance and documentation
- Describe the different cleaning methods, such as manual cleaning, automated cleaning, and cleaningin / out of- place (CIP/COP).
- Understand the product risk associated with non-compliance of cleaning validation standards and regulations, and the criticality of developing correct protocols, acceptance criteria, and processes.
- Identify critical cleaning parameters, including as cleaning agents, water usage, equipment, surfaces, and sampling methods.
- Understand the concept of deviations and change management in the context of cleaning validation.
