World Journal of
Pharmaceutical and Life Sciences

MICROBIAL CONTAMINATION OF PHARMACEUTICALS

Mayank K. Dhawan*, Smridhi Khurana, Sanyam Nasa and Dr. P. K. Sahoo

ABSTRACT

Contamination of Pharmaceutical Preparations by microorganisms has gained significance as it poses a health hazard in patients whose immunity is already weak and compromised by illness. Besides pharmaceutical products contaminated Ith microbes, irrespective of their nature i.e. pathogenic or harmless; can bring about the physicochemical changes in the product. Study of the same is being considered in this article, along with the attempt to understand the various sources of contamination. Microorganisms like gram-negative pathogens – namely Acinetobacter species, multidrug resistant (MDR) Pseudomonas aeruginosa and Carbapenem resistant Klebsiella species and Escherichia coli are emerging as significant contaminants. Organisms normally found on the human skin like Propionibacterium spp., Propionibacterium acnes, Micrococcus spp., Staphylococcus spp., Staphylococcus epidermis, Streptococcus salivarius and Streptococcus mutans are all potential hazards. Sources of the contamination may be due to manufacturing or application. Contamination due to manufacturing may further be due to - Materials, which constitutes Raw material and Packaging material; Process Environment, which constitutes, improper cleaning, lack of air clearance, absence of cleaning status labeling or use of open manufacturing environment; Personnel, which may be due to direct contact, access of unauthorized personnel, malpractices like eating food etc. or Not following GMPs (Good Manufacturing Practices), SOPs (Standard operating procedures), STPs (Standard Testing Procedures) and MFCs (Manufacturing Formula Cards); Equipments , which includes, inadequate cleaning and sanitation, defective equipment or inappropriate design; Facilities, which constitutes improper filtration, inappropriate magnitude of pressure drop, improper ratio of fresh air to recirculated air; Utilities like low water activity or addition of preservatives. Contamination due to application may also be due to personnel, equipment or environmental conditions.

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