What is Microbiology?

Microbiology is the scientific study of microorganisms, including bacteria, viruses, fungi, and protozoa. It explores their structure, function, behavior, and their interactions with the environment and other living organisms. Microbiology plays a crucial role in various fields such as medicine, agriculture, biotechnology, environmental science, and food safety, helping us understand and harness the power of these tiny organisms for the betterment of humanity.

• The scientific study of microorganisms:
  • Bacteria
  • Fungi
  • viruses

• Microorganisms can grow from a single cell (the origin)and live in the air and on surfaces.
• They survive based on the environment, conditions, and nutrients that are available. Some can grow with oxygen (aerobic) and some can grow without oxygen (anaerobic). 
• They favor a habitat that is warm and moist.  
• Some of them multiply within 20 minutes, but most of them need a few hours. This is called the incubation time.
• Their sizes are too small to see with the naked eye, they can be seen only by using scientific methods, such as Culturing, Microscopes, and Genetic/Molecular Biology. These methods take a few days to get results.
• They keep nature clean by removing toxins from water and soil and degrading organic matter from dead plants and animals. 
• In humans, they help to balance bacteria levels in the digestive system.
• They play a critical role in the environment we are living in. 

However, some of them are harmful

• Some microorganisms are pathogenic and due to their size, they have a massive impact on our life and the products we make. Therefore, Sterilization Process is very important in production operations.
  
• Example of Pathogenic Microorganism:
  • E. coli –  diarrhea
  • S. aureus – skin/solft tissue infection
  • Salmonella enterica/typhi – typhy fever, nausea, and vomiting.
  • P. aruginosa – skin/soft  tissue infection
  • B. subtilis – lung infection
  • C. albican – yeast infection

Potential Sources of Contamination in Manufacturing:

• Operator
• Process
• Environment/Housekeeping
• Incoming raw material

This table classifies some typical contaminants by size.

Regulatory and Standards 

Per government regulation and standards: FDA, European, ISO-13485, and ISO 14698  Standards, Microbiologists are required to assess cleanrooms and control environments for contamination and introduce contamination strategies on pharmaceutical/medical device products

Contamination Control 

• Employees are required to follow Quality Control Procedure/GMP at all times.
  • Gowning.
  • Hand washing.
  • Personal hygiene.
  • Sterilization/Cleaning process.

• Environmental monitoring
  • Viable air and surface monitor testing
  • High efficiency particulate air (HEPA) filter/airlock
  • High energy UV-light units to kill microbial that are trapped by the filter media.
  • The flooring system is in good condition

Biocontamination Hazard Analysis and Control Plan. 

Do you need any help?

The biocontamination hazard assessment identifies any gaps in current manufacturing practices that individually or combined may lead to unacceptable biocontamination of the diagnostic device and thus affect the required performance.

At Q6consulting, our mission is simple: We are here to share our expertise to help your business succeed. We have a hands-on and straightforward approach to tackling your business needs.

Author: 

Alzira Martins, PhD, Executive Advisor @ Q6consulting LLC

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