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?
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Article
A risk based approach to sterile filtration
Drug quality cannot be assured only by finished-product testing. Process validation is required to establish scientific evidence that a process is capable of delivering an effective and safe …
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
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…
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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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Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Some other surgical products are not manufactured to be sterile at all, also posing risk. Each of these situations is the result of risk assessments that are based on the nature of the product and its…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…