Fluorescence-assay on traces of protein on re-usable medical devices: cleaning efficiency

Citation
D. Verjat et al., Fluorescence-assay on traces of protein on re-usable medical devices: cleaning efficiency, INT J PHARM, 179(2), 1999, pp. 267-271
Citations number
15
Categorie Soggetti
Pharmacology & Toxicology
Journal title
INTERNATIONAL JOURNAL OF PHARMACEUTICS
ISSN journal
03785173 → ACNP
Volume
179
Issue
2
Year of publication
1999
Pages
267 - 271
Database
ISI
SICI code
0378-5173(19990315)179:2<267:FOTOPO>2.0.ZU;2-E
Abstract
The cleaning of re-usable medical devices before disinfection or sterilizat ion is recognized as being an essential phase. Detection of residual protei ns can be used to validate the process, provided a sufficiently sensitive m ethod is employed. A fluorescent method is presented, using orthophtalaldeh yde (OPA) bound to N,N dimethyl-2-mercaptoethylammonium, to demonstrate the presence of amino acids on a medical device following cleaning. The sensit ivity of this method (10(-5) g/l) was assessed and the applicability of thi s detection technique is verified, using three types of carriers (steel bla des, glass tubes or ceramic penicylinders), three types of contaminants (ye ast extract, bovine albumin with native sheep's blood and formaldehyde fixe d fibrin). In this context, studies involving formaldehyde-fixed fibrin are more sensitive and are to be recommended. (C) 1999 Elsevier Science B.V. A ll rights reserved.