TITLE

Cleaning Validation: Factors Affecting Recovery Data and Material of Construction Grouping

AUTHOR(S)
Forsyth, Richard J.
PUB. DATE
November 2009
SOURCE
Journal of Validation Technology;Autumn2009, Vol. 15 Issue 4, p91
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Material of construction is a factor in recovery of residue for cleaning validation. Analysis of existing recovery data demonstrated that recovery factors for drug products on different materials of construction could be categorized into several groupings. The groupings based on the recovery data were not aligned with the material composition (e.g., metal, plastic, glass, etc.). An examination of additional factors clarified the grouping of materials versus recovery data. Materials of construction used in laboratory studies to represent commercial manufacturing equipment must be representative of equipment. Materials of construction that exhibit low recovery should be replaced wherever practical for an alternative material with a higher recovery to avoid any potential cross-contamination due to slow release of residue from the material of construction. If problematic materials cannot be released, equipment should be dedicated or restricted for use to the active pharmaceutical ingredient with low recovery.
ACCESSION #
47337029

 

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