October 03, 2021: Pharmaceutical Interview Questions and Answers
#SpecifiedOrganismsAndSource #InterpretSpecificationLimitForMicrobiologyTest
1. When test for specified organisms found positive, what it indicates for each organism?
| Name of specified organism | Source | Risk |
| Escherichia coli | Gut flora | The organism indicates fecal contamination |
| Salmonellae | Gut flora | Fecal contamination with high pathogenicity |
| S. aureus | Human skin human skin and nose, detectable in feces. | High pathogenicity potential. risk to product quality due to resistance to preservatives |
| P. aeruginosa | Water inhabitant mainly stored water | High pathogenicity potential |
| Clostridia | Found where anaerobic conditions are prevalent | pathogenicity potential |
| C. albicans | Candida albicans is an opportunistic pathogenic yeast that is a common member of the human gut flora. | Potential pathogens for specific situations E.g. vaginal preparations. |
2. How to interpret specification limit for microbiology test results for bio burden testing?
Pharmacopeia allows variability in test results equal to a factor of two. E.g. if the specified microbial limit is 10, the maximum accepted microbial count is 20 CFU and still meets the product specification.
● 10 microorganisms: maximum acceptable count = 20
● 100 microorganisms: maximum acceptable count = 200
● 1000 microorganisms: maximum acceptable count = 2000