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

Batch placebo method

A placebo batch is manufactured and checks are done for carry-over of the previous product

- Expensive and laborious process

- Little assurance that the contaminants are dislodged

- Particles not necessarily uniformly dispersed

- Method used in conjunction with rinse and/or surface sampling method(s)

- Samples taken throughout the process of manufacture

- Sensitivity of the assay may be greatly reduced by dilution of the contaminant

9.4 Batch placebo method

Note: This method relies on the manufacture of a placebo batch which is then checked for carry-over of the previous product. It is an expensive and laborious process. It is difficult to provide assurance that the contaminants will be dislodged from the equipment surface uniformly. Additionally, if the particles of the contaminant or residue are large enough, they may not be uniformly dispersed in the placebo batch.

9.4.1 The batch placebo method should be used in conjunction with rinse and/or surface sampling method(s).

9.4.2 Samples should be taken throughout the process of manufacture.

Traces of the preceding products should be sought in these samples. (Note that the sensitivity of the assay may be greatly reduced by dilution of the contaminant.)