Search results for " sterile"

Article Ensuring Sterility in Small-Scale Production
Finally, there needs to be consideration to final product testing and the appropriate number of samples needed to ensure the product is sterile and safe for patients. The samples needed for testing sh…

Article Implementing QbD in Sterile Manufacturing
Critical quality attributes  BioPharm: In implementing a QbD approach, what would you identify as the critical quality attributes (CQAs) in sterile manufacturing and aseptic processing? …

Article Virus purification using superheated buffer in place (SBIP) for packed bed chromatography
Regardless of origin from egg, bacteria, or cells, any purification process must deliver a sterile final product, defined by the absence of bacteria and fungi or their spores. The US Food and Drug Adm…

Article Guidelines for selecting normal flow filters
The variety of filter materials available to process development scientists is large—from depth media containing nominally-rated micron-sized filtration-matrices to validated sterile filtration membra…

Article Aseptic Processing: Keeping it Safe
…ues or manufacturing errors such as incomplete sterilization or nonsterile components being added to sterile products (1). The large-scale meningitis outbreak in 2012 has been attributed to poor …

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
(See working cell bank)  media Plural form of medium, a (usually sterile) preparation made for the growth, storage, maintenance, or transport of microorganisms or other cells.  meiosis Specia…

Article Fluid Handling in Biopharma Facilities
Facility layout can help determine how companies handle fluid transfer and storage, and increased use of modular facilities and single-use systems (SUS) in the production and transfer of sterile fluid…

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
These controls were developed through interpretation of regulatory requirements for both nonsterile and sterile biologics manufacturing decades ago and have been replicated based on successful regulat…

Article Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth. Jan 01, 2015 By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…

Article Defining Risk Assessment of Aseptic Processes
It is important to remember aseptic does not mean sterile and the objective in aseptic processing is to keep the product, components, and environment as close to sterile as possible. This is accomplis…

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