Cleaning Validation

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Course Details

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Course Description

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 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.

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