September 13, 2021: Pharmaceutical Interview Questions and Answers
#Microscope #PharmacopoeialChaptersForMicrobiology
1. Explain the parts of compound light microscopes used in the pharmaceutical microbiology laboratory?
● Illuminator: Light source at the base of the microscope enable better view of object;
● Condensor: This is a two lens system that collects and concentrates light from the illuminator and directs it to the iris diaphragm;
● Iris diaphragm: regulates the amount of light entering the lens system;
● Stage: This is a platform for the slide with hole in the center to let light from the illuminator pass through. It consists of clips to hold the slide lace;
● Eye pieces: To view object;
● Objectives: To magnify the object as per rating on it
2. What are the pharmacopoeial chapter and sections applicable for microbiology?
| Pharmacopoeial chapter(s) | Use |
| Microbiological examination of nonsterile products: total viable aerobic count (Ph. Eur. 2.6.12, USP <61>) USP <2021> Microbial enumeration tests-nutritional and dietary supplements USP <2023> Microbiological attributes of nonsterile nutritional and dietary supplements | Organism count in raw materials, water, finished products |
| Microbiological examination of nonsterile products: tests for specified organisms (Ph. Eur. 2.6.13, USP <62>) USP <2022> Microbiological procedures for absence of specified microorganismsnutritional and dietary supplements | Type of organisms present in raw materials, water, finished products |
| Ph. Eur. 5.1.4 Microbiological quality of pharmaceutical preparations/USP <1111> Microbiological attributes of nonsterile pharmaceutical products | Determining limits and control factors |
| Sterility (Ph. Eur. 2.6.1, USP <71>) Pyrogens/endotoxin Rabbit Pyrogen Test (Ph. Eur. 2.6.8, USP<151>) Limulus amoebocyte lysate (LAL) bacterial endotoxin test (Ph. Eur. 2.6.14, USP<85>) | Sterility test for finished products endotoxin test for raw materials, pharmaceuticals waters, finished products |
| Antimicrobial preservative efficacy testing (Ph. Eur. 5.1.3, USP <51>) | Antimicrobial preservative efficacy |
| Microbiological assay of antibiotics (E.P 2.7.2., USP<81>) | Assays of antibiotic |
| USP <1112> Application of water activity determination to nonsterile pharmaceutical products | Water activity can be used to predict microbial proliferation in the product |
| USP <1211> Sterilization and sterility assurance of compendial articles. There are a series of subchapters that describe specific sterilization methods | Sterilization and microbial reduction |
| USP <55> Biological indicators | Biological indicators for assessing microbial reduction |
| USP <1113> Microbial characterization, identification, and strain typing | Microbial identification |
| USP <1117> Microbiological best laboratory practice | Management of microbiological good laboratory practice |
| USP <1116> Microbiological control and monitoring of aseptic processing environments | Environmental monitoring for aseptic environments |
| Ph. Eur. 5.1.6 Alternative methods for control of microbiological quality/ USP <1223> Validation of alternative microbiological methods | Alternative methods/ Rapid microbiological methods |
| USP <1115> Bioburden control of nonsterile drug products | Bioburden control |
| USP <1227> Validation of microbial recovery from pharmacopeial articles | Microbial method validation |
