Related Experiment Videos
Systematic development and validation of sanitization protocols for a chromatographic system designed for
R F Burgoyne1, M C Priest, K L Roche
1Millipore Corporation, Waters Chromatography Division, Milford, MA 01757.
Journal of Pharmaceutical and Biomedical Analysis
|November 1, 1993
Summary
This study details microbial contamination challenges in protein purification systems. It validates membrane filtration for sensitive bioburden testing and confirms sodium hydroxide and ethanol effectively reduce microbial load.
Area of Science:
- Biotechnology
- Pharmaceutical Manufacturing
- Microbiology
Background:
- Protein therapeutic production relies on genetic engineering and biotechnology.
- Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) are crucial for product recovery and purification.
- Validated clean-in-place (CIP) procedures require microbial bioburden analysis to ensure cleaning efficacy.
Purpose of the Study:
- To describe microbial challenges in chromatography systems.
- To evaluate membrane filtration for high-sensitivity microbial contamination measurement.
- To assess the effectiveness of cleaning solutions in reducing microbial contamination.
Main Methods:
- Performing an extensive microbial challenge on a chromatography system.
- Utilizing membrane filtration methods for precise microbial bioburden quantification.
- Applying sodium hydroxide and ethanol solutions for cleaning validation.
Main Results:
- Membrane filtration proved effective for high-sensitivity microbial contamination detection.
- Sodium hydroxide and ethanol solutions demonstrated significant multilog reduction of microbial contamination.
- The study successfully assessed the efficacy of cleaning protocols in a GMP/GLP context.
Conclusions:
- Validated CIP procedures are essential for safe protein therapeutic manufacturing.
- Membrane filtration is a reliable method for monitoring microbial contamination.
- Chemical cleaning agents like sodium hydroxide and ethanol are effective for microbial control in bioprocessing equipment.