Systematic development and validation of sanitization protocols for a chromatographic system designed for biotherapeutics purification.
Production of protein therapeutics through the application of genetic engineering and biotechnology techniques requires comprehensive attention to good manufacturing practice and good laboratory practice (GMP/GLP) guidelines for product recovery and purification. Validated clean-in-place procedures are part of the master method and require analysis of microbial bioburden to assess the efficacy of cleaning protocols. This article describes the extensive microbial challenge of a chromatography system, the use of membrane filtration methods for high sensitivity microbial contamination measurement, and the effectiveness of sodium hydroxide and ethanol solutions in achieving multilog reduction of microbial contamination.
Burgoyne
R F
RF
Millipore Corporation, Waters Chromatography Division, Milford, MA 01757.
Priest
M C
MC
Roche
K L
KL
Vella
G
G
D000128:Acholeplasma laidlawii; D000818:Animals; D001688:Biological Products / Q000302:isolation & purification*; D001709:Biotechnology / Q000379:methods*; D002845:Chromatography / Q000295:instrumentation*; D006224:Cricetinae; D004203:Disinfection; D004866:Equipment Contamination; D000431:Ethanol; D006801:Humans; D051379:Mice; D011550:Pseudomonas aeruginosa; D012972:Sodium Hydroxide; D015003:Yeasts
D001688:Biological Products; D000431:Ethanol; D012972:Sodium Hydroxide