Search results for "cleaning" in Articles / App Notes
Article
Ensuring Sterility in Small-Scale Production
There needs to be a cleaning program defining the proper use of disinfectants/sporocides before, during, and after processing. It means there should be a gowning qualification/requalification program …
Article
Evaluating E&L Studies for Single-Use Systems
Traces of residual compounds from previous manufacturing runs and from cleaning processes (e.g., ethanol) were also detected.
Single-parts extraction study
The single-parts option …
Article
Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …
Article
Technology solutions simplifying chromatography unit operations
Chromatography operations typically involve steps such as resin slurry preparation, column packing, cleaning, unpacking, and resin storage. While each of the aforementioned steps can potentially be …
Article
Perfusion in the 21st Century
Similarly, changes in market demand can be met more rapidly, while use of disposable equipment reduces capital investment, cleaning and validation costs, as well as equipment footprint. Perfusion is a…
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 …
Article
Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…
Article
Platform Approach Speeds Process Development
In stainless-steel facilities, cost-intensive installations for cleaning and steaming in place are required to enable changeover activities. In a disposable process chain, changeover activities are re…
Article
Continuous Processing for the Production of Biopharmaceuticals
The CFIR was found to offer productivity 15 times higher than that produced through a batch process; this higher productivity was primarily due to the elimination of shutdown, cleaning, and filling st…
Article
Developing Cleaning-in-Place Protocols
Cleaning conditions for chromatography media can be screened in a couple of working days using 96-well microtitre plate formats. A study with a Protein A resin illustrates the approach in this appli…