Development of surface swabbing procedures for a cleaning validation program in a biopharmaceutical manufacturing facility

Autor:	Somesh Nigam, Anthony Scotton, Gary Ruezinsky, Silvia Lombardo, Randall G. Rupp, Prasad Inampudi
Rok vydání:	1995
Předmět:	business.industry Environmental science Bioengineering Process engineering business Cleaning validation Applied Microbiology and Biotechnology Biotechnology Biopharmaceutical manufacturing
Zdroj:	Biotechnology and Bioengineering. 48:513-519
ISSN:	1097-0290 0006-3592
DOI:	10.1002/bit.260480514
Popis:	Validation of direct surface swabbing procedure in conjuction with total organic carbon (TOC) analysis is described for a biopharmaceutical product manufacturing operation. The swabbing technique was found to be very effective in reliably detecting very low levels of residuals for diverse process streams (limit of detection of approximately 0.5microg/cm(2)). However, contaminant recovery was significantly dependent on both the type of contaminant and the processing surface. This study serves as a guide for designing effective cleaning validation protocols based on direct surface swabbing techniques. (c) 1995 John Wiley & Sons, Inc.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fcb5672c654adabcae2b7bc5736ec445 https://doi.org/10.1002/bit.260480514 Zobrazit plný text záznamu Plný text