Course Detail

Cleaning validation is a process to ensure that equipment cleaning procedures are removing residues to predetermined levels of acceptability. This 2-day course will examine each aspect of building and maintaining a complaint cleaning validation programme. Course Contents: Module 1 - Regulatory Background – FDA,IMB approach Module 2 - Designing a cleaning Procedure Module 3 - Basic Chemistry of Cleaning Module 4 - Best Industry Approach to Cleaning Studies Cleaning Strategies Sampling Methods Acceptance Criteria Module 5 - Cleaning g Methods Manual Clean in Place (CIP) Steam in Place (SIP) Clean out of Place (COP) Module 6 - Calculation of carry over limits Module 7 - Development of Bracketing procedures Module 8 - Hold Times (DEHT),(CEHT) Module 9 - Identification of Hard to Clean Places Module 10 - Documentation Module 11 - Designing a Cleaning Validation Test Protocol Module 12 - Cleaning of Dedicated equipment Note: The above syllabus may change during the training course to provide more detail in aspects, which have been ascertained to be of greater value to the trainee.