Title 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
PHARMD GURU Page 2  DOP testing: It is used for air filtration in laminar air flow. DOP testing is a process in which the integrity of HEPA (High efficiency particulate air) filter is tested through the introduction of particulates. DOP when burnt forms smoke particles. When air is passed through the HEPA filters, smoke is added to the passage and blockage of pores is checked. If there is 99.9% of blockade, then it indicates the HEPA filters are capable to retain any particles which are above 0.3μ.  Bubble pressure test: The pressure at which the first bubble appears is the bubble point pressure. It mainly indicates the pore size of the membrane filter and helps in the identification of the sterilization procedure. D = 30γ/P D = pore size, γ = surface tension and P = pressure CHEMICAL INDICATORS: These are the substances which gives the visibility by change in color.  Browne's tube: It is a chemical indicator with a heat sensitive solution within the glass tube which changes from red to green when tube is subjected to high temperature. It is used for monitoring dry heat & sterilization of fluid's process.  Bowie dick tape is an adhesive tape used in autoclaving (heating under high pressure with steam) to indicate the specific temperature.  Witness tube in an autoclave contains some crystals, which melts when the final temperature point is achieved. Compounds like sulphur, acetanilide and benzoic acid are used. BIOLOGICAL INDICATORS: These are used in all types of sterilization process. It is also known as the spore test. Resistance spores with suitable organisms are taken in tubes and are taped. These tubes along with the sterilizing substances are finally sterilized. After sterilization, spores are checked for viability. These are done by taking spores in a medium, and incubating them. If there is no growth of organism, it indicates spores are killed and sterilization is done.
PHARMD GURU Page 3  Geobacillus stearothermophilus is used for heat sterilization. After sterilization, it is kept in a special broth and usually grows at higher temperature of 55 for five days.  Bacillus subtilis is used for dry heat sterilization.  For ethylene oxide sterilization or gaseous sterilization. bacillus subtilis bacteria is used. In filtration type of sterilization, biological indicators are used. Organisms like serratia marcescens and brevundimonas diminuta are very small in size. If the organisms are retained on the membrane, it indicates filtration is done properly. Hi, In our syllabus copy, they asked about only brief introduction to validation. So, we prepared notes according to it. However if you want to add more notes, we are adding some pages from textbook. Do your material search and prepare notes according to it.
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