(1999; 168 pages) [Spanish]
4.2.3 Analytical methods/cleaning limits
The toxicity of the residual materials should be considered when deciding on the appropriate analytical method and the residual cleaning limits. The residue limits established for each piece of apparatus should be practical, achievable and verifiable. The manufacturer should be able to show, with supporting data, that the residual level permitted is scientifically based. Another factor to consider is the possible non-uniformity of the residue. The level of residue found by random sampling, such as taking a swab from a limited area on a piece of equipment, does not necessarily represent the highest level of contamination.