Path finder process validation of dry heat sterilizer in Parentral manufacturing unit

Abstract

Sterile products have several unique dosage form properties, such as freedom from microorganisms, freedom from pyrogens, freedom from particulates, and extremely high standards of purity and quality; however, the ultimate goal in the manufacture of a sterile product is absolute absence of microbial contamination. Dry Heat Sterilization method is use for Depyrogenation of Glassware (Ampoule, Vial), Metal Equipment, Heat stable Oils, Ointment, and Powders etc. on based on oxidation of microorganism, Conduction & Convection Method. Equipment utilized to provide the dry heat medium must be validated every half year to ensure the system is able to consistently provide Dehydrogenated or sterile product and meets the quality. Validation should be done by proper planning. The efficiency of any heat treatment is determined by the design and source of the heat. To study must done on Heat distribution, Heat penetration, Bioburden and pyroburden determination and microbial/Endotoxin challenges, Minimize the utility cost and Man hours during sterilization cycle. An attempt have been done in this project work to consider all the suitable Critical and Variable parameters in regards to Heat Penetration and Least Temperature required for Sterilization and cost saving.