Determination of microbial recovery for some pharmaceutical raw materials and passive monitoring at production area and microbiology laboratory at Egyptian pharmaceutical company

Abstract

Objective: This study aims to evaluate the validity of pharmaceutical raw materials obtained from an Egyptian pharmaceutical factory to ensure the accuracy of the examination findings before they are used in the manufacturing process. On the other hand, it also aims to determine the environmental microbial count at the microbiology laboratory and production areas to prevent microbial contamination during production and during microbiological analysis. Methods: Assessment of microbiological quality control according to pharmacopeia as plate method by using TSB media with a concentration of 0.1% tween 80, for passive monitoring using settled plate (TSA) media. Results: the percentage of microbial recovery for lactose monohydrate was 89%,

μMET: A Novel Reusable Microfluidic Chip for Precision Microbial Enumeration Tests

“…The microbial enumeration test (MET) is crucial for determining if a product meets microbiological safety standards by evaluating its bioburdenthe count of viable microorganisms present . As a cornerstone of quality control, MET finds extensive application in industries such as pharmaceutical, cosmetics, and food, safeguarding the production, transportation, and storage processes . Furthermore, cutting-edge MET techniques significantly bolster medical diagnostics and microbiological research. , For instance, when working with droplet-based single-cell cultivation, sorting, or sequencing, accurately quantifying and diluting a bacterial suspension are essential to ensure a high probability and efficiency of isolating individual cells, as guided by the Poisson distribution …”