Search results for "sanitization" in Articles / App Notes
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
In this study, the predefined sanitization method developed for ÄKTA pilot 600 was assessed. In a microbial challenge test, parts were exposed to a bacterial strain recommended by the United Stat…
Article
Sanitization Opportunities for Protein A Resins
Several protein-based chromatography resins are also sensitive to such harsh sanitization conditions. As an alternative, the oxidizing agent peracetic acid (PAA) could be used in the control of such c…
Article
Sanitization of AxiChrom™ Columns Packed with Chromatography Resin
This study evaluates sanitization methods based on 1 M sodium hydroxide (NaOH) as sanitization agent using methodology previously developed for peracetic acid (PAA).
Access study data here…
Article
Efficient Sodium Hydroxide Sanitization with a Novel Procedure of AxiChrom™ Columns Packed with Chromatography Resin
Here, we describe a microbial challenge test with a concentration of 1-M NaOH to mimic typical sanitization practices employed by the biopharma industry for a broad range of resins. The final version …
Article
Re-use of Protein A Resin: Fouling and Economics
…fer to remove non-binding impurities; elution at low pH and conductivity; and finally, cleaning and sanitization of the column for next use. The widespread applicability and similarity of operating c…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
“There remains some perceived sensitivity to vaporized hydrogen peroxide (VHP) sanitization of contact surfaces and secondary surfaces as automated systems are generally contained within isolators/RAB…
Article
Cleaning Protein A Resins with 1 M NaOH
Historically, protein A resins have been less chemical resistant to high concentrations of sodium hydroxide (NaOH), the commonly used cleaning and sanitization agent in bioprocessing. In this applicat…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Such procedures may include aseptic training, purchasing of suitable raw materials, raw material supply-chain management, and cleaning and sanitization, for example.
Biosafety should b…
Article
Selecting a Comprehensive Bioburden Reduction Plan
The identified risks and severity levels inform planning of raw material selection, facility design, process elements and conditions, cleaning and sanitization requirements, establishment of alert/act…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
…ies, its sensitivity to alkaline conditions prevents the use of rigorous and cost-effective CIP and sanitization protocols based on NaOH.
Compared to conventional Protein A resins, one of the aff…