Microorganisms、too embarrassed to ask others about!(Part 9)

2023/07/21 Others

Microbiological Control

Microbial Control
This part will focus on "controlling microorganisms" in pharmaceutical and medical device companies.
As explained in the previous Parts, microorganisms are extremely diverse. Therefore, to completely control all microorganisms, we must use very strong methods. On the other hand, however, there are restrictions on the measures that can be taken, such as not being able to use highly toxic agents in the manufacturing of pharmaceuticals and other products. Therefore, even if we speak of control , it is necessary to devise a combination of several relatively mild measures rather than a single strong method.
In this section, we will provide explanations from the standpoint of general measures. Therefore, depending on the situation at your plant, these measures may not necessarily be appropriate or insufficient. For individual cases, it is necessary to obtain the cooperation of internal and external experts.

1. Explanation of terms
We often see terms related to "microbial control" in our daily lives. Especially since COVID-19 has become a social issue, it seems to have become more and more frequent.

  • Sterilization: the process of killing or eliminating all microorganisms on an object. Sterilization results in a sterile product.
  • Sterile: the absence of living (i.e., capable of multiplying) microorganisms.: the absence of living (i.e., capable of multiplying) microorganisms.
  • Sterility: a state in which no viable microorganisms are present.
  • Inactivation: to kill microorganisms.
  • Disinfection: to kill only harmful or target organisms in order to prevent infection.
  • Preservation: inhibition of microbial growth.
  • Antibacterial: to inhibit the growth of bacteria.
  • Removing bacteria: to reduce the effective number of bacteria that can grow from an object by physical, chemical, biological, or other action.
  • Bacteriostatic: to inhibit the growth of bacteria.
  • Bioburden: surviving microorganisms on the product prior to sterilization

 

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About Author

Tatsuo Furuya

Career

Senior Consultant, GMP Platform, CM Plus Corporation
After working in sterilization management, microbiology, and quality assurance at Johnson & Johnson, Creative Medic, and Boston Scientific, he joined CM Plus, Inc. in 2013.
While working for the medical device manufacturer avobe, he participated in the Health and Welfare Science Research Group and various sterilization-related committees as a specialist in ethylene oxide sterilization.

The profile is the information as of the time of writing.

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