The Northeast Biomanufacturing Center and Collaborative (NBC2) provides resources on microbiological control, such as textbook chapters, interactive lessons, and learning modules. These resources, included in the attached zip file, "describe various sources of microbial contamination within a biomanufacturing facility/process and explain the different microbiological cleanliness standards required for the manufacture of biopharmaceutical drug substances and drug products." Resource titles include API 20 E Instructions, API 20E Microbial Identification SOP, Autoclave Operation, Chapter 8: Microbiological Control, Environmental Monitoring, Four Step Gram Stain, Quality Control Microbiology Skill Standards, Mycoplasma Testing, Gowning for Entry into Biomanufacturing Suite, and more.
Below is a list of the files contained within the .zip attachment. The size of each file is included in parenthesis.
Microbiological Control (12 files 3.9 MB)
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