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Microbiological Control


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)

  • Appendix A: Master Glossary (22886923819658983-masterglossary-restricted.pdf 499 KB)
  • Overview: Quality (84895790614231225-quality-unit-overview.pdf 404 KB)
  • Quality Control Technician (Microbiology) (141773160675081282-competencies-quality-control-microbiology.pdf 68 KB)
  • Chapter 8: Microbiological Control (537288293383421006-chapter-8.pdf 1.2 MB)
  • SOPs
    • SOP: LAL ASSAY - Gel Clot Method (82132238393810885-qcm-6-lal-gel-clot-assay-sop-mc3.pdf 25 KB)
    • SOP: Gowning for Entry into Biomanufacturing Suite (90481328133641468-minibiomanqcm-4-gowning-sop-mc3.pdf 27 KB)
    • SOP: Mycoplasma Testing (212407304482583792-qcm-8-mycoplasma-testing-sop-mc3.pdf 43 KB)
    • Four Step Gram Stain SOP (400695485656182867-four-step-gram-stain-sop.pdf 732 KB)
    • SOP: M Air T Millipore Air Tester (402359872852555758-qcm-3-air-tester-millipore-sop-mc3.pdf 102 KB)
    • SOP: Operation of MetOne Model 229 B Laser Particle Counter (889964778368971245-qcm-1-laser-particle-counter-model-229b-sop.pdf 87 KB)
    • SOP: Gram Stain (949622441610949652-qcm-5-gram-stain-sop-mc3.pdf 219 KB)
    • API 20E Microbial Identification SOP (952588815608370598-api-20e-microbial-identification-sop.pdf 515 KB)
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