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Aug 06, 2026
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BIOT 117 - Quality Control Techniques
PREREQUISITES: BIOT 101 - Introduction to Biotechnology
PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 2
LAB HOURS MIN: 2
DATE OF LAST REVISION: Summer, 2011
Students will be introduced to those principles associated with quality control from a life sciences perspective. Students will learn about common microbial contaminants and how to prevent them. Students will also gain experience with common monitoring techniques used in the biotech industry.
MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course the student will be expected to:
- Understand a brief history of the regulatory and quality compliance requirements in the United States.
- Understand basic microbiology and the impact of bioburden and microbial contamination in the food and drug industries.
- Understand the importance of sterilization and perform practices related to the process.
- Demonstrate ability to correctly identify basic microorganisms.
- Understand the general requirements for personal hygiene and housekeeping in cGMP manufacturing.
- Demonstrate ability to pass clean room gowning requirements.
- Understand and demonstrate the ability to properly clean using industry standards and techniques.
- Understand the importance of product testing.
- Demonstrate a few common techniques and compendial assays recommended by the Code of Federal Regulations for the food and drug industry.
- Understand the importance of good documentation requirements for the food and drug industry.
- Demonstrate good documentation skills.
- Demonstrate the ability to keep an industry standard notebook.
COURSE CONTENT: Topical areas of study include -
- Common microbial contaminants in life sciences
- Principles related to bioburden
- Minimizing contamination
- Sterilization
- Product testing
- Autoclaves
- Facility design
- Air monitoring
- Water monitoring
- Personnel practices
- Media preparation
Course Addendum - Syllabus (Click to expand)
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