Source of Contamination in sterile Products
The possibility of contamination in sterile products in pharmaceutical companies is an issue of concern. Contamination in pharmaceutical companies can occur in two different forms. These may either be cross contamination or micro contamination. Micro contamination refers to a form of contamination that involves microorganisms such as bacteria while cross contamination involves a form of contamination that is caused by other products such as two products mixing up unknowingly.
The critical elements of sterile products that are most affected include product purity, quality and strength. Possibility of contamination in sterile products occur through various sources and in different ways. It is important to note that the main contamination sources of sterile products include production machinery and equipment, poor design of the facility, pharmaceutical personnel, materials used for production and HVAC system among others.
Consequently, the different ways of contamination often depend on the source, for instance, poor air supply in the HVAC system results in sterile product contamination through reducing the ratio of recirculated air to that of fresh air. In addition to that, lack of proper labeling of manufacturing materials also serve as a way of sterile product contamination in pharmaceutical companies among other ways.
It is therefore, the responsibility of pharmaceutical companies to ensure adoption of practices that reduce the possibility of contamination in sterile products as they can cause serious impacts on the end users/ patients. This can be achieved through adoption of activities such as formulation of contamination prevention methods, procedures for detection of contaminants, identification of contaminants nature and finally, suggesting approaches towards contamination issue/problem.
It is also important to for these companies to put in mind the possibility of contamination in sterile products as most contamination also occur due to the failure of this consideration. According to Parag Kolhe, Mrinal Shah and Nitin Rathore, most sterile product contamination fail to be detected due to the ignorance of contamination possibility by the investigation personnel in Pharmaceutical companies. The failure to consider the contamination possibility is the greatest contributor of contamination in sterile products.
There are various possibilities of contamination in sterile products in Pharmaceutical companies today. These include the failure to conduct a thorough review of sterile products data in all the areas classified. Another possibility is the lack of consideration of the filling line contamination and focus on a tight time frame in which the the filling of sterile products occurred rather than analyzing the data on the products year’s worth.
The result/impact of contamination possibility in sterile products depend on various factors. These include the administration form, sterile product nature and the nature of the contaminants. Adoption of an effective management of contamination possibility by Pharmaceutical companies therefore, aids in the reduction of the contamination possibility risks in sterile products.
Sterile products purity, quality and strength can be improved or maintained throughout its manufacturing/ processing period all through its shelf life till its administration or use by the patient. This can be done through taking into consideration the possibility of contamination in sterile products by pharmaceutical companies.
