Lecture 5 Flashcards
What are the types of microbial standards for pharmaceuticals?
Absolute exclusion of all microorganisms: For sterile products
Numerical limit on all organisms: Sets a maximum allowable number of microorganisms
What are absolute exclusion standards, and can you provide examples?
Requires that certain microorganisms, (E. coli and Salmonella), be completely absent from products. Sterile products must pass sterility tests with no organisms present, oral and topical medicines don’t need to be sterile but must be free from harmful bacteria.
What are numerical limit standards, and can you provide examples?
Numerical limit standards specify the maximum number of microorganisms allowed. For example, for oral dosage forms and topicals, there can be no more than 100 cells of non-specified aerobic organisms per ml or gram of the preparation.
What are the difficulties in including absolute microbial counts in official standards?
Microbial counts are unreliable because they vary with factors such as sample age, the media used, incubation temperature, and the analyst. Official standards often require the absence of specific organisms or pathogens and use total viable counts for internal process control.
What are the European Pharmacopeia microbiological quality categories for pharmaceutical preparations?
The European Pharmacopeia categorizes pharmaceutical preparations into 4 categories based on microbiological quality:
Category 1: Preparations required to be sterile.
Category 2: Preparations for topical use and the respiratory tract.
Category 3:
A: Oral and rectal preparations with a total viable aerobic count of ≤10³ bacteria, and no E. coli.(b)no Salmonella or Staph. aureus.
Category 4: Herbal medicinal products:
A: Herbal products where boiling water is added before use,
B: ≤10⁵ bacteria, with no E. coli or Salmonella.
What do the acronyms TAMC and TYMC stand for, and what are these tests based on?
TAMC: Total Aerobic Microbial Count, based on counting aerobic bacteria.
TYMC: Total Yeasts and Molds Count, based on counting fungi, including yeasts and molds.
