Search results for "cleaning validation"
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
Best Practices in Qualification of Single-Use Systems
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
nobeastsofierce/Shutterstock.com
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Article
Reducing Cross-Contamination Risks in Process Chromatography
“With typical bioprocessing tools, a lot of effort and care goes into cleaning and cleaning validation of contact surfaces since any contamination in the purification process can be detrimental to the…
Article
Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
While sometimes perceived as costly, these ready-to-use products minimize the need for hardware qualification and cleaning validation, which can be rather costly and timeconsuming for biomanufacturers…
Article
Process Chromatography Selection for Downstream Processing Applications
are used for one campaign only, omitting the cleaning steps and the need for cleaning validation. There is a continuous development of new chromatography resins combining separation modes. One example…
Article
Single-use technologies in downstream process intensification
When using conventional chromatography solutions, cleaning and cleaning validation consumes a considerable amount of time and facility resources. Cleaning-in-place protocols are performed before, duri…
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …