Distribution of bacterial contamination in non-sterile pharmaceutical materials and assessment of its risk to the health of the final consumers quantitatively

• Main Author: Mostafa Essam Eissa
• Format: Article
• Language: English
• Published: SpringerOpen 2016-09-01
• Series: Beni-Suef University Journal of Basic and Applied Sciences
• Subjects: Bacterial contamination; Pharmaceutical product; Biochemical identification; Quantitative risk assessment; Enterobacteriaceae; Burkholderiaceae
• Online Access: http://www.sciencedirect.com/science/article/pii/S2314853516300658

Bacterial contamination control in pharmaceutical products is a critical aspect in the field of drug manufacturing industry due to the encountered risk to the patients' health and possibly their life. The application of commercial bacterial identification system is crucial to identify the type of contamination and its source to anticipate the impact of bioburden on the products and setting corrective and preventive actions. During the period of one year, random samples from raw materials and final products were tested according to United States Pharmacopeia, and those that showed suspect results for specified microorganisms and/or out-of-specification limits or showed out-of-trend results were subjected to further identification by using miniaturized biochemical identification system after performing Gram stain. From the total bacterial isolates of the investigated products, more than 60% were primarily belonging to Micrococcaceae 16.98% (empty hard gelatin capsules), Enterobacteriaceae 18.86% (vaginal cream applicator, plastic caps for bottles, Sorbitol solution, finished hard gelatin capsule product, topical cream and oral suspension) and Bacillaceae 24.53% (Talc powder, liquid oral preparation and finished hard gelatin capsule product). Gram Positive and Negative samples were 56.60% and 41.51% respectively from the total investigated sample products and materials. Finished pharmaceutical products constituted 53.33% and 68.18% from Gram-positive and Gram-negative microorganisms respectively. An approach to quantitative risk assessment for pharmaceutical products was conducted on selected medicinal items and showed that Enterobacteriaceae followed by Burkholderiaceae contributed by more than 80% to the major hazard that could be delivered to patients through drugs. The applied risk can be used as a milestone for setting goals by pharmaceutical companies to improve the safety of medicinal products microbiologically and to identify the major sources of the risk to work on it in order to deliver safe drugs to the customers.