Search results for " sterile" in Articles / App Notes
Article
Sterilization Trends for Single-Use Consumables
…roducts, making sterility assurance imperative, states Christy Eatmon, global subject matter expert, sterile drug products in the Pharma Services business of Thermo Fisher Scientific. Processes used …
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
For most biologics, therefore, sterility must be assured by using aseptic processing techniques, which involve use of sterile raw materials, equipment, and processes under conditions that prevent micr…
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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…
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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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In-person seminar: Manufacture of sterile medicinal products
Are you developing a Contamination Control Strategy? Join us for a free in-person seminar focused on applications at the end of the bulk drug substance workflow including drug product applicat…
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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 …
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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 …
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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…