Microbial contamination of Ointments

Introduction The worldwide interest in reports of the microbial contamination of pharmaceutical preparations was triggered by the finding of plaque vaccine contaminated with spores of Clostridium tetani in 1907 . The presence of microbial contaminants was not only found to cause physicochemical changes that led to the spoilage of numerous products, but was also proved to be a potential health hazard to the consumer, as documented by the large number of incidents of drug-related infections.

Introduction Among the pharmaceutical drugs, including the oral and topical dosage forms, the presence of contaminating total viable bacteria exceeding the acceptable limit of <10² cfu/g especially in the eye and ear ointments , brings a major threat in public health measures. The contaminating microorganisms including Clostridium tetani, Pseudomonas aeruginosa, fungi, viruses, etc. may trigger the sustainable spoilage of the finished products with the loss of its therapeutic properties and hence serious infections are likely to arise during medication

Evaluation of Ointments & Creams The main characteristics need to be checked are: Cracking of creams (separation of oil and water) Development of granular and lumpy appearance Marked change in viscosity Crystal growth Microbial contamination

Microbial contamination evaluation Microorganisms can grow, if no preservative is added, or even if added, its efficiency is reduced due to interaction with other ingredients Microorganisms may get into the preparation during handling and storage Therefore, aseptic techniques of handling are needed Antimicrobial assay should be performed according to official monograph, usually: Direct inoculation method Membrane filtration method

Microbial contamination evaluation Using pour plate technique the number of micro-organisms initially present in the preparation are determined. Solutions of different samples of the preparation are made and mixed with Tryptone Azolectin (TAT) broth separately. All cultures of the micro-organisms are added into each mixture, under aseptic conditions. All mixtures are incubated. The number of micro-organisms in each sample are counted on 7th, 14th ,21st , and 28th days of inoculation. Microbial limits: On 14th day, the number of vegetative cells should not be more than 0.1% of initial concentration. On 28th day, the number of organisms should be below or equal to initial concentration.

Microbial contamination and preservative efficacy of topical creams T Microbial contamination and preservative efficacy of topical creams T. Na'was and A. Alkofahi' Faculty of Medicine and Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan

Conclusion From previous review and data of researchers we conclude that the microbiological contamination is common among the pharmaceutical drugs including ointments. The pharmaceutical companies need to pay attention for methods of investigating microbial contamination during the manufacturing and filling of tubes with ointment and to use suitable preservatives in addition to applying good manufacturing practice. We also conclude the possibilities of contamination sources are: Presence of microorganisms in the raw materials or in the manufacturing water. Lack of microbiological monitoring of the equipments and manufacturing environment. Packaging defect. Personal unhygienic casualty. Improper storage temperature and humidity

References Microbial contamination and preservative efficacy of topical creams T. Na'was and A. Alkofahi' Faculty of Medicine and Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan L. Lachman, H.A, Lieberman and J.L. Kanig, Theory & Practice of industrial pharmacy, Lea & Febieger, Philadelphia Latest Edn Microbiological Quality Investigation of Eye and Ear Ointments Available in Bangladesh,Md. Asif Hossain, Kohinoor Akter Raton, Rashed Noor