• A Review of the Impact of Microbial Contamination in Non-Sterile Oral Drugs
  • Zahra Ghadimi,1,*
    1. Young Researchers & Elite Club, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran


  • Introduction: Microbial contamination in non-sterile oral drugs poses a significant risk to public health. This comprehensive review aims to assess the impact of microbial pathogens in non-sterile oral drugs and provide an overview of the associated risks and challenges.
  • Methods: This review assesses the impacts of microbial contamination on non-sterile oral drugs and the potential consequences for patients. It examines references related to microbial specification, types of pathogens, and their sources. It also investigates the infections caused by these pathogens and the prevalence of microbial contamination. Furthermore, the review explores current methods for detecting, identifying, and establishing the standard range of dangerous microbial pathogens in non-sterile oral drugs.
  • Results: Microbial contamination in drugs poses an infectious risk and can alter the chemical, physical, and organoleptic properties of the drugs and the contents of active ingredients. Additionally, microorganisms can convert drugs into toxic products. Regardless of the dosage form and route of administration, non-sterile oral drugs must adhere to microbiological purity criteria outlined in the appropriate editions of the EP and USP. This includes checking for specific pathogens and monitoring the Total Aerobic Microbial Count (TAMC) and Total Mold and Yeast Count (TMYC). Microbial contamination can occur through various means, such as the environment, high humidity levels, and uncontrolled air quality. It can also arise from natural raw materials, contaminated water, poor personal hygiene practices, open wounds, coughing and sneezing, dirty hands, feces, and soiled clothing.
  • Conclusion: This review emphasizes the need to continuously assess microbial pathogens in non-sterile oral drugs to protect public health and improve patient outcomes. Collaboration between regulatory authorities, pharmaceutical companies, and healthcare providers is essential in addressing this issue. Adhering to Good Manufacturing Practice (GMP) guidelines and implementing effective quality control measures throughout production are crucial for reducing the risk of microbial contamination in pharmaceutical products.
  • Keywords: microbial contamination, non-sterile oral drugs, pathogens, prevalence, public health.