How to proceed to validate the instrument used for strilization?
Answers
Answer:
Explanation:
1. VALIDATION OF STERILIZATION PROCESS
2. LARAIB JAMIL M.Phill Registered scholar Department of Pharmaceutics University Of Balochistan
3. Validation • Validation may be defined as : Establishing documented evidence which provides high degree of assurance that specific process will be consistently produce a product meeting its predetermined specifications & quality attributes.
4. FDA published guidelines • 3 principal should involve in validation process: 1. To build sterility into a product. 2. To demonstrate maximum level of probability that sterilization methods has established sterility to all batches of unit. 3. To provide greater assurance of result of end product sterility test.
5. Sterilization • “The act or process, physical or chemical, that destroys or eliminates all viable microbes including resistant bacterial spores from a fluid or a solid.” • Sterility: “The reduction of anticipated levels of contamination in a load to the point where the probability of survival is less than 10⁻⁶.” • This referred to as STERILITY ASSURANCE LEVEL (SAL)
6. Commonly used sterilization methods are • Dry heat • Moist heat • Gas (Ethylene oxide, Hydrogen peroxide) • Radiation (Gamma or electron) • Others (UV, Steam & Formaldehyde, Filteration )
7. Process of microbial destruction D-value : The time in minutes required for a one-log or 90% reduction of a specific microbial population under specified lethal conditions. For steam sterilization it is determined at a constant temperature Importance of D-value : 1. It is specific kinetic expression of each microorganism. D-value will be effected by • Type of microorganism used as biological indicator • The formulation component & characteristics (e.g- Ph) • The surface on which microorganism is exposed (e.g- glass, plastic, in sol, in dry powder etc)
8. 2. Knowledge of D-value Is necessary for calculation of Z-value 3. The D-value is also used in calculations of F-value
9. • Z-value: is a term used in microbial thermal death time calculations. It is the number of degrees the temperature has to be increased to achieve a ten fold (i.e. 1 log10) reduction in the D-value. • F-value: The F value is a measurement of sterilization effectiveness. It is defined as number of minutes to kill number of microorganism with specified Z-value at a specific temperature
10. • Fₒ-value: It is saturated steam sterilization process in which the equivalent amount of time, in minutes at 121°C or 250 F, which has been delivered to a product’s final container for sterilization process with reference to microorganism possessing a Z-value of 10 (BP-2009) In general to aqueous preparation in steam deliver cycle the Fₒ value for not less than 8 to every container in autoclave is considered satisfactory