WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 3): Cleaning Validation: Validation

WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 3): Cleaning Validation
(2006; 43 pages)

Table of Contents

Validation

Cleaning validation protocols (6)

Bracketing:

Representative product - most difficult to clean.
Equipment - only when it is similar or the same equipment in different sizes (e.g. 300 l, 500 l and 1000 l tanks).

- Alternative approach may be to validate the smallest and the largest sizes separately.

4.1.7 When a representative product is chosen, this should be the one that is most difficult to clean.

4.1.8 Bracketing by equipment should be done only when it is similar equipment, or the same equipment in different sizes (e.g. 300-l, 500-l and 1000-l tanks). An alternative approach may be to validate the smallest and the largest sizes separately.