Sterilization - validation, qualification requirements

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1ISPE Boston ChapterFramingham MA 19Sep20131Sterilization - validation, qualification requirementsDawn Tavalsky2Sterilization - OverviewObjectives Discuss definition of Sterile Briefly describe Sterilization methods Describe approaches to be used for the validation of a Sterilization process using Moist Heat as an example Describe requirements for routine monitoring and control of Sterilization Review issues that are specific to other Sterilization processes23Sterile Products - Overview Certain pharmaceutical products must be sterile injections, ophthalmic preparations, irrigations solutions, haemodialysis solutions Two categories of sterile products those that can be sterilised in final container (terminally sterilised) those that cannot be terminally sterilised and must be aseptically prepared 4Sterilization - OverviewWhat is the definition of sterile ? Free from microorganismsIn practice no such absolute statement regarding absence of microorganisms can be proven Defined as the probability of 1 in a million of a container being contaminated (10-6) This referred to as the Sterility Assurance Level (SAL) Organisms are killed in an exponential fashion35Definition of Sterile MICROBIAL INACTIVATIONNt= Noe-kt020040060080010001200TimeNo of surviving remainingLog No remainingNo remaining10003681355018721000Log No of Sterile D.

Sep 19, 2013 · 3 5 Definition of “Sterile” MICROBIAL INACTIVATION Nt = Noe-kt 0 200 400 600 800 1000 1200 Time No of surviving organisms-2.00-1.50-1.00-0.50 0.00 0.50 1.00 1.50

  Inactivation