Pharma Focus Asia

Distribution Of Bacterial Contamination In Non-sterile Pharmaceutical Materials And Assessment Of Its Risk To The Health Of The Final Consumers Quantitatively

Authors: Mostafa Essam Eissa


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.


Bacterial contamination; Pharmaceutical product; Biochemical identification; Quantitative risk assessment; Enterobacteriaceae; Burkholderiaceae

Citation: Mostafa Essam Eissa Distribution Of Bacterial Contamination In Non-sterile Pharmaceutical Materials And Assessment Of Its Risk To The Health Of The Final Consumers Quantitatively

Received: 25 September 2015, Revised: 18 July 2016, Accepted: 6 August 2016, Available online: 20 September 2016

Copyright: © 2016 Beni-Suef University. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (


The new methodology – applied in the evaluation of the microbiological risk assessment for the pharmaceutical products – has provided advantages as follows: (1) It can replace the conventional qualitative method of microbiological risk analysis that is based on subjective ranking. (2) It takes into account the different manufacturing variables that affect the finished delivered product to the consumer. (3) It provides objective method for numerical evaluation of the current product quality and can measure the degree of change of this quality when any of the parameters has been changed. (4) It combines both microbiological quality and quantity effect in the pharmaceutical firm into one risk assessment value. On the other hand, it highlights the gap between the continuously increasing list of objectionable bugs and available information and literatures about their infective doses per specific route of administration. Furthermore, little research work was done on infectious doses for patients with specific disease conditions or on chronic use of specific medications that modify immunity and health states. The relative microbial distribution used in risk value determination is required to be updated annually – to reflect the recent bioburden distribution profile – by each pharmaceutical plant in an attempt to achieve better assurance of delivering microbiologically safe drugs to patients in the community by monitoring the variation in the value of the risk index.


This work was supported partially financially by HIKMA Pharma pharmaceutical company – 2nd Industrial zone - 6th of October City. The practical part of all experiments was performed in the microbiology laboratory in the quality control department. Data gathering and issuing was performed by HIKMA microbiology laboratory team. Reference and writing style review was performed by Dr. Engy Refaat Rashed.

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