• 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, condition, and nutrients that are available. Some can grow with oxygen (aerobic) and some can grow without oxygen (anaerobic).
• They favor habitat that is warm and moist
• Some of them multiply within 20 minutes, but most of them need 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 degrade organic matter from dead plants and animals.
• In human they help to balance bacteria level 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 operation.

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 cleanroom and control environments for contamination and introduce contamination strategy on pharmaceutical/medical device products

Contamination control

• Employees are required to follow Quality Control Procedure/GMP at all time.
  • Gowning.
  • Hand washing.
  • Personal hygiene.
  • Sterilization/Cleaning process.
• Environmental monitoring
  • Viable air and surface monitor testing
  • High efficiency particulate air (HEPA) filter/air lock
  • High energy UV-light units to kill microbial that trapped by the filter media.
  • Flooring system are in good condition

Biocontamination Hazard Analysis and Control Plan.
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The biocontamination hazard assessment identifies any gaps to current manufacturing practices that individually or combined may lead to unacceptable biocontamination of the diagnostic device and thus affecting the required performance.

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