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