Search results for " aseptic"
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Achieving Process Balance with Perfusion Bioreactors
The system must also be operational under aseptic conditions for the duration of the perfusion culture.
Perfusion design needs
For perfusion processes, the bioreactor must be designed to withs…
Article
What's in Your SOP?
The use of video recording could be most helpful for people who need to gown appropriately to enter into an aseptic manufacturing area.
Remember there is no set rule dictating the format…
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Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
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Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
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The New World of Biopharmaceutical Manufacturing
Steam-in-place (SIP) and clean-in-place (CIP) systems, with sophisticated automation, were technological advances in stainless-steel systems to ensure aseptic operation (where needed) and minimization…
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Being Thorough When Transferring Technology
This infrastructure must provide a working environment that isolates the manufacturing and lab personnel from cytotoxic chemicals while providing the aseptic environment required for manufacturing a b…
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Drug Quality Key to Innovation and Access
These challenges apply to biosimilars and cutting-edge therapies, as well as to the need for modern aseptic processing methods able to reliably produce both new and generic sterile injectables. The in…
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Real Time Continuous Microbiological Monitoring
Conclusion
The pharmaceutical industry is moving toward continuous manufacturing and control to ensure full understanding of the aseptic manufacturing process and product quality. Envi…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Such procedures may include aseptic training, purchasing of suitable raw materials, raw material supply-chain management, and cleaning and sanitization, for example.
Biosafety should b…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Knowing where to place biosafety cabinets, if aseptic connections are required, and knowing any special design modifications to the single-use system (e.g., extra clamps, material selection, handling …