Effect of Sterilization on Elastomeric components Used in Pharmaceutical Industry

Sterilization (or sterilisation) is a term referring to any process that eliminates (removes) or kills all forms of microbial life, including transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) present on a surface, contained in a fluid, in medication, or in a compound such as biological culture media. Sterilization can be achieved by applying the proper combinations of heat, chemicals, irradiation, high pressure, and filtration. Several methods are available for sterilization and among all steam & gamma sterilization are most suitable methods for elastomeric components. In this study the effect of steam & gamma sterilization has been compared with non-sterile components. For this comparison EP & USP methodology has been used. Steam and gamma which has been used as a source for sterilization that may affect the molecular chain & crosslink density of elastomeric components. The study on effect of sterilization serves to help understand the potential deterioration of physical and chemical properties, the possible impact to functionality and the potential changes to the extractable/leachable profile as a result of sterilization.