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%, 85%, 94%, 92%, 91%, and 91%, while Croscarmellose recorded 81%, 85%, 85%, 85%, and 88%, Mannitol recorded 86%, 85%, 91%, 83%, 86%, and 88%, Magnesium stearate recorded 91%, 85%, 94%, 89%, and 91%, and finally, Talc Powder recorded 94%, 85%, 94%, 91%, 87% and 85% for Pseudomonas aeruginosa, Salmonella enterica, Staphylococcus aureus, Candida albicans, Bacillus subtilis and Escherichia coli respectively for each pharmaceutical raw material. Methods of analysis recorded under acceptance criteria in the selected pharmaceutical factory according to pharmacopeia. On the other hand, the microbial quality of air for the production area selected by an Egyptian pharmaceutical company was under acceptance limits. Conclusion: All quality control methods and assessments of pharmaceutical raw materials, laboratories, and production areas must be performed to measure and control microbial contamination in the pharmaceutical industry and then produce high-quality pharmaceutical products free of microbial contamination, and methods of analysis must be recorded under acceptance criteria in the selected pharmaceutical factory according to pharmacopeia. On the other hand, the microbial quality of the air for the production area and microbiology laboratory that was selected by an Egyptian pharmaceutical company was under accepted limits. All quality control methods and assessments of pharmaceutical raw materials, laboratories, and production areas must be performed to measure and control microbial contamination in the pharmaceutical industry and then produce high-quality pharmaceutical products free of microbial contamination.