SYSTEMATIC DEVELOPMENT AND VALIDATION OF SANITIZATION PROTOCOLS FOR A CHROMATOGRAPHIC SYSTEM DESIGNED FOR BIOTHERAPEUTICS PURIFICATION

被引：24

作者：

BURGOYNE, RF

PRIEST, MC

ROCHE, KL

VELLA, G

机构：

[1] MILLIPORE CORP,DIV PROC,BEDFORD,MA 01730

[2] MILLIPORE CORP,DIV ANALYT,MILFORD,MA 01757

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 1993年 / 11卷 / 11-12期

关键词：

CLEAN-IN-PLACE; SANITIZATION; FPLC; BIOBURDEN ANALYSIS; MICROBIAL CHALLENGE;

D O I：

10.1016/0731-7085(93)80118-K

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

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 parr 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.

引用

页码：1317 / 1325

页数：9