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

Analytical methods

Validated analytical methods - able to detect residuals or contaminants:

- specific for the substance(s) being assayed

- at an appropriate level of cleanliness (sensitivity)
Sensitive and specific - may include:
- chromatographic methods (e.g. high pressure liquid chromotography (HPLC), gas chromotography (GC), and high pressure thin-layer chromatography (HPTLC)). Others include (alone or in combination), e.g. total organic carbon (TOC), pH, conductivity, ultraviolet (UV) spectroscopy, and ELISA

10. Analytical methods

10.1 The analytical methods should be validated before the cleaning validation is performed.

10.2 The methods chosen should detect residuals or contaminants specific for the substance(s) being assayed at an appropriate level of cleanliness (sensitivity).

10.5 Suitable methods that are sensitive and specific should be used where possible and may include chromatographic methods (e.g. high pressure liquid chromotography (HPLC), gas chromotography (GC), and high pressure thin-layer chromatography (HPTLC)). Other methods may include (alone or in combination) measurement of total organic carbon (TOC), pH, or conductivity; ultraviolet (UV) spectroscopy; and enzyme-linked immunosorbent assay (ELISA).