Development of surface swabbing procedures for a cleaning validation program in a biopharmaceutical manufacturing facility.
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.
Lombardo
S
S
Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New York 10591.
Inampudi
P
P
Scotton
A
A
Ruezinsky
G
G
Rupp
R
R
Nigam
S
S