Lecture 4 Flashcards
What samples need to be analyzed microbiologically?
Samples include raw materials, samples, end-products, water, air, surfaces, and personnel.
What guides the choice of microbiological tests to be carried out?
The choice should be based on specifications, standards, guidelines, microbial ecology, and risk assessment.
What dictates the frequency of testing?
The product’s history, associated hazards, its role in disease and infection, and its likelihood of causing spoilage.
How are test methods and their validation determined?
Only recognized standard methods should be used, and each test must be validated and controlled using positive and negative controls.
What specifications should be applied in microbiological testing?
Specifications include limits for the number of organisms per unit and serve as the basis for acceptance or rejection of samples.
What are typical sample size and number of samples required in each test?
The sample size must follow requirements set by USP Directives, or other standards. It should be related to the sensitivity of the method used
What considerations are made for the type of sample?
Samples must be representative of the whole batch, collected using statistically applied random sampling plans.
What are the cost considerations in microbiological testing?
The cost-benefit ratio of microbiological monitoring should be assessed, and testing should be limited accordingly to balance costs.
What are the different indicator organisms, and why are they significant?
Total Coliforms: Indicate general sanitation levels.
E. coli: Indicates direct fecal pollution and has public health significance.
Enterococci: Indicate fecal contamination in various samples.
Staphylococci: Indicate handling issues and poor personal hygiene.
Why are pathogens or objectionable microorganisms not routinely analyzed for in many products?
Pathogen testing are time-consuming and require enrichment. Using positive controls containing pathogens also poses a danger to the analyst.
Identify 10 objectionable microorganisms in the pharma/biopharma/medical device industry and explain why
Staphylococcus aureus: Can cause food poisoning and skin infections.
Salmonella spp.: Can cause food poisoning.
Campylobacter spp.: Can cause gastroenteritis.
E. coli: Can cause gastroenteritis.
Vibrio parahaemolyticus: Can cause mild gastroenteritis.
Listeria monocytogenes: Can cause listeriosis, especially in at-risk groups.
Bacillus cereus: Can cause food poisoning.
Clostridium botulinum: Can cause botulism, leading to paralysis.
Yersinia enterocolitica: Can cause yersiniosis, a form of gastroenteritis.
Group A streptococci: Can cause scarlet fever and skin infections.
