Validation of cleaning procedures for highly potent drugs. II. Bisnafide.
The objective of this work was the development and validation of procedures designed to clean glass and stainless steel surfaces after exposure to the experimental anticancer drug, bisnafide. The cleaning procedures, using 5% acetic acid water, Alconox, and water, were validated using a wipe test and an HPLC method developed to quantitate low levels of bisnafide. The procedure developed for cleaning stainless steel is more stringent than that for glass because of the apparent greater affinity of bisnafide for stainless steel. The HPLC method is shown to be linear and reproducible (RSD 4.4% or less), with a detection limit of 4 ng/ml. Recoveries of 95.1, 83.5, and 70.0% were obtained from the wipe pads, glass plates, and stainless steel plates, respectively, at levels of approximately 0.7-1.7 ng/cm2. The cleaning procedures are shown to clean glass and stainless steel plates to less than 0.19 and 0.33 ng bisnafide/cm2, respectively. These results further demonstrate the need to fully characterize the recovery of drugs from surfaces and swabs in order to properly validate cleaning procedures. In addition, they demonstrate the potential need to develop surface-specific cleaning procedures.
Segretario
J
J
DuPont Merck Pharmaceutical Company, Pharmaceutical R & D, Wilmington, Delaware, USA. James.Segretario@DuPontMerck.com
Cook
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SC
Umbles
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Walker
J T
JT
Woodeshick
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Rubino
J T
JT
Shea
J A
JA
D000970:Antineoplastic Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D007546:Isoquinolines / Q000032:analysis*; D008698:Mesylates / Q000032:analysis*; D013678:Technology, Pharmaceutical
D000970:Antineoplastic Agents; D007546:Isoquinolines; D008698:Mesylates; C084899:bisnafide