PATH FINDER PROCESS VALIDATION OF MOIST HEAT STERILIZER IN PARENTRAL MANUFACTURING UNIT
Objective:- Moist heat sterilization is the most important in pharmaceutical Parentral manufacturing unit. 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. An attempt has been made in this research work to validate the Moist Heat Steriliser with technicalÂ parameters Â classified as Critical and Variable Parameters.
Method:- Moist Heat Sterilization method is used for Sterilization ofÂ Accessories,Garments ,Silicon tubes, filtration assembly etc. on basis of coagulation of cell proteins. Moist Heat Steriliser Â is validated every half year to ensure the system is liable to consistently, provide dehydrogenated or sterile product and meets the quality standards. Validation is done by proper planning by taking regular load and experimental load of regular batches of the product. The study is done on Heat distribution, Heat penetration, and Bio burden determination, Minimize the utility cost, and Man hours during sterilization cycle.
Result:- The result found in this research workÂ leads to setting up New approach to Validate Moist Heat Steriliser in Parentral manufacturing unit with cost effective way.
Conclusion:- The Path finder validation process setup through this project is Cost saving through Energy as well as Man Hour Saving and Breakage of Units also maintain Sterility in product. It is helpful to find out Hot and Cold Spots in Moist Heat sterilizer and Designing and Â Â Placement of RTDs. The findings were submitted to the Parentral Department of Vital HealthCare Pvt. Ltd., Satpur. MIDC, Nashik.
KEYWORDS:-Moist heat Sterilization , Process Validation , Critical and Variable parameters.
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