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.
Highlights
In the pharmaceutical industry, the presence of microbial contamination on raw materials during pharmaceutical preparation causes spoilage of drugs and effects on human health[1]
Microbial limit tests were important for pharmaceutical non -sterile terms to ensure that pharmaceutical terms were free from any microbial contamination that was similar to and dissimilar with that found around 50% of all tested products were heavily contaminated by Klebsiella, Bacillus, and Candida species
While the percentage recovery was 81%, 85%, 85%, 85%,85%, and 88%, at microorganisms Escherichia coli, Salmonella enterica, Staphylococcus aureus, Candida albicans, Bacillus subtitles, Pseudomonas aeruginosa in the following, all of the percentage above are greater than 70%, indicating that tryptone soya broth with 0.1% Tween is effective in neutralization of croscarmellose
Summary
The presence of microbial contamination on raw materials during pharmaceutical preparation causes spoilage of drugs and effects on human health[1]. Validation of a method is the process of deciding whether a method is sufficient for its intended use 7 Pharmaceuticals raw materials such as lactose monohydrate are used as a filler and diluents in tablets and capsules, and to a more limited extent in lyophilized products and infants, while talc powder is used in oral solid dosage formulations as a lubricant and diluents, Croscarmellose is used as a disintegrate for capsules, tablets, and granules in oral pharmaceutical formulations, Mannitol is used as a diluent in tablet formulations, moisture-sensitive active ingredients, direct compression tablet applications, Magnesium stearate is used as a lubricant in capsule and tablet manufacture at concentrations ranging from 0.25% to 5.0% w/w. Pharmacopeias offer standards, specifications, and test methods that are required to be used in the pharmaceutical industry to ensure that pharmaceuticals achieve perfect qualitycontrol tests 9 This current work is aimed at studying the microbial quality of the selected pharmaceutical raw materials that are commonly used in the pharmaceutical industry, as well as determining the microbial quality of the air in production areas
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