Tiêu đề 14. BRIEF INFORMATION ON VALIDATION.pdf ✅

PHARMD GURU Page 1 INTRODUCTION TO VALIDATION IN STERILIZATION: Validation is defined as:  Action of checking or proving the validity or accuracy of something.  Establishing documented evidence which provides high degree of assurance that specific process will be consistently produce a product meeting its predetermined specifications and quality attributes. PRINCIPLES: Basic principles of validation are: 1) Installation qualification: To ensure that equipment used for sterilization is installed properly. 2) Operational qualification: Calibration and testing of instrument is done to ensure the proper working of the instrument. 3) Performance qualification: To ensure the completion of actual sterilization methods and to check whether the actual conditions are achieved or not. It is normally done by the biological, chemical or physical indicators. INDICATOR: An indicator is a substance or device used to monitor and verify that the sterilization process has effectively achieved the desired level of microbial destruction. These indicators serve as a means of assessing the performance of the sterilization process. TYPES OF INDICATORS: PHYSICAL INDICATORS: Physical indicators involve observing the display on the sterilizer and to record the time, temperature and pressure.  Dosimeter is physical indicator used in the radiation type of sterilization. When a dosimeter is kept in a container, a change of color is observed if the proper close of radiation is present. BRIEF INFORMATION ON VALIDATION