Ensuring the Biological Integrity of Raw Materials
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Pharmaceutical TechnologyPharmaceutical Technology-05-15-2017
Volume 2017 eBook
Issue 1
Pages: s31-s34
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
Contamination with microbes, mycoplasma, viruses, and adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can occur from many sources, raw materials are the most significant source of contamination.
Strategies for preventing contamination including upfront testing of materials, barrier disinfection methods, and adhering to best practices in processing and sanitation are explored.
Avoidance of animal-based raw materials, as well as careful sourcing of any materials used, are discussed.
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Pharmaceutical Technology’s 2017 Biologics and Sterile Drug Manufacturing eBook.
Articles in this issue
Clean, Disinfect, and Validate
Kill the Bioburden, Not the Biological Indicator
Cold Chain Logistics for Personalized Medicine: Dealing With Complexity
Ensuring the Biological Integrity of Raw Materials
Getting Biopharmaceutical Tech Transfer Right the First Time
Developing an Injectable Compound for a Dual- Chamber Delivery System
Case Study: Retrofitting Two New High-Purity Water Systems
Single-Use Bioreactors Have Reached the Big Time
Parallel Processing
Cost Considerations Drive Lean Technology in Biomanufacturing
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