Microbial Evaluation of Some Non-sterile Pharmaceutical Preparations Commonly Used in the Egyptian Market
Abstract
Purpose: To determine the type and incidence of predominant microorganisms in certain non-sterile pharmaceuticals immediately after collection and one year later.
Methods: All pharmaceutical samples were subjected to the following examinations: total bacterial count and presence of microbial pathogens, using conventional techniques. Attempts were also made to identify the isolates. The bioburden rate of some of the syrups and oral drops after storage for 0, 6 and 12 months were evaluated in order to assess the effect of storage on microbial contamination level. Results: Microbial load varied among the pharmaceutical preparations with the highest microbial load in suspensions and the lowest in tablets. Bacterial counts ranged from 10 to more than 103 CFU per ml or g. The bacterial count at 6 and 12 months were significantly different from that at 0 month (p < 0.05). The isolated organisms were either of human flora types, essentially Gram-positive bacteria, or airborne fungi.
Conclusion: The isolated organisms were either of human flora types, principally, Gram-positive bacteria, or air-borne fungi and the stored preparations lack an effective preservation. Several measures, including equipment automation, monitoring programs and post-marketing surveillanceare required to reduce the level of microbial contamination of non-sterile pharmaceutical products.
Keywords: Microbial contamination, Bacteria, Fungi, Non-sterile pharmaceuticals
Submission of a manuscript to this journal is a representation that the manuscript has not been published previously and is not under consideration for publication elsewhere.
All authors named in each manuscript would be required to sign a form (to be supplied by the Editor) so that they may retain their copyright in the article but to assign to us (the Publishers) and its licensees in perpetuity, in all forms, formats and media (whether known or created in the future) to (i) publish, reproduce, distribute, display and store the contribution, (ii) translate the contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or abstracts of the contribution, (iii) create any other derivative works(s) based on the contribution, (iv) to exploit all subsidiary rights in the contribution, (v) the inclusion of electronic links from the contribution to third party material where-ever it may be located, and (vi) license any thrid party to do any or all of the above.
