An Overview of theValidation Approach for

Moist Heat Sterilization,Part II

B.M.Boca,E.Pretorius,* R.Gochin,R.Chapoullie,and Z.Apostolides

P

This article illustrates a

qualification–validation strategyfor moist heat sterilizationandbriefly discusses the sterility

concept and common sterilizationprinciples.In Part II,the authorsdiscuss the qualification–

validation procedure,includingthe installation,operational,andperformance qualification phases,when requalification–revalidationis required,and a system forchange control.

art I ofthis article was published in the September issueofPharmaceutical Technologyand provided an updateofthe validation ofmoist heat sterilization,reviewing thethe sterility concept,sterilization principles,developmentofsterilization cycles,and the measurement ofsterilization effi-ciency.Part II discusses the qualification–validation procedureand the probability ofnonsterility ofa load during the valida-tion ofthe steam sterilization process.

The qualification–validation procedure

As recommended by the American National Standards Insti-tute (1),the qualification–validation ofa moist heat steriliza-tion process involves

●qualification ofthe autoclave by checking its performanceagainst the design specifications

●validation ofthe process by establishing the actual effective-ness and reproducibility ofthe cycle in relation to the prod-uct and the loading configurations

●assessment ofpossible changes in the product that could haveoccurred during sterilization.

A typical qualification program is outlined in the United StatesPharmacopeia(USP) (2).However,choosing a particular quali-fication approach depends on the type ofautoclave,its actualcondition (whether it is new or refurbished),the critical para-meters controlling the process,the geometry ofthe chamber,the type ofgoods that are going to be sterilized,and the steril-ity assurance level (SAL) required.Therefore,before the quali-fication process is started,the user must become acquainted withthe autoclave type and its characteristics.It is important to as-semble a validation team consisting ofat least a user represen-tative and a member ofthe quality assurance division.

After the decision has been made to qualify an autoclave,theprocess ofcollecting information must be performed in a logi-cal manner.Because extensive literature about this topic is avail-able,one should be selective when consulting informationsources and retrieve only the type ofinformation applicable tothe appropriate sterilizing principle and the operating para-meters ofthe sterilizer being validated.

The first step in collecting information is to consult nationalstandards.Ifthese are not available,then one should consultinternational standards.Because validation cannot be per-B.M. Bocais a doctoral student at theUniversity of Pretoria in South Africa; E.Pretorius, PhD,is a senior lecturer in theDepartment of Anatomy, Faculty of Medicine,University of Pretoria 0002, Pretoria, SouthAfrica, tel. 27 12 319 2533, fax 27 12 3192240, rpretori@medic.up.ac.za; R. Gochinis the quality assurance manager of the

Pharma Division at Roche Products Pty Ltd.;R. Chapoullieis the quality manager atSteren Support Systems CC; and Z.

Apostolides, DSc,is senior lecturer inthe Department of Biochemistry, University ofPretoria.

*To whom all correspondence should be addressed.