Sterilization of Implants

Biomaterials Science: An Introduction to Materials in Medicine; Ratner, B.D.; Hoffman, A.S.; Schoen, F.J.; Lemmons, J.E.; Eds.; 1996, Academic Press: USA ISBN: 0-12-582460-2
pp. 415420

C H A P T E R

Implants and Devices

JAMBS

~~CHAEL KLEIN, JOHN

M.ANDERSON, BRYAN BEVACQUA, A. NORMAN CIUNIN,LINDAM. GW, ALM S. H o ~ , B. KOWALSKI, ROBERT MORRISSEY, F. STEPHENA. OBSTBAUM, BUDDY D R ~ T N W .
FREDERICK SCHQEN, J.
SJRAWN,
A m

DIANA WHIITLESEY

9.1 ~ T R O D U C I ~ O N Rdmick 1. Schaan

rhup,em dnrribD bionutoials td medical dcviccs. Tbe areas & o m illustrate and medical considtrations and

bacteria, yeasts, molds, and viru9cs. T h e p of even m e bacterium on an implant rtnders it n o n d e . S& sbotdd t v not be confused with dtanlintos. A shiny stainless ~ e sd h c t u m y a s d y b. nonstdlc ( m n h e t d with n u microorganisms),while a rusty nail will be s t d e ahtrexpsore tv an appropriate sterilization m d d . E m fscal m a t e d a n
measured or p m d ? For relatiwly small numbers of implants lassuming the implant is not l a r p to t a r in its entirev), d r y can b bp immersing the item into liquid mimbiologid dnuc media. Lf it is sterile, no rnigobial growth will be h e w e d ; if it is nonsteriie, the culture mcdium will k m c turbid M a d t of microbid (Fig. I). T & g small numbers o f samples, however, d not giw very meaningful information m about the sterility of a large batch of implane that have subjecled to an industrial-scnle sterilization , n S~teriktion validation smdia are used to determine what is d e d the sterility assurance lwel (SAL). The SAL i s the probability that a given implant rffill d nonsttrile following exposure t a given sterilization p. o n , accepd SAL, tor im&nts is 10-6 or a probnbil,F of no than one in don

be ~~~~d

How then is sterility

sterile,

area hasirs own unique probIems

9.2 STERUINTION O IMPLANTS F

fohn 8. Kowalski m ~ d Robert F. Morrissey
e body of a human or an animal umt i~~feaion can lead ta that

with the enumeration rhe bioburdm, of viable microo* on he implant just prior ro sterilization (Morrisscy, 1981). Bioburdtn is usuaUy dcternlinad on 10-30 samples and involveswashing, shaking, or sonicating the microorganisms off tbe implant into a sterile m r y fluid such as a saline solurion. By using an-

implant --Ie. The determination of a SAL

STEMUTY AS A CONCEPf
*'Sterile" i s defined as the absence of all living organisms. n i s cspeaally includes the realm o m i m ~ s o r s m s such as f ,

ventional microbialogical technique, the number of mimoorganisms in the recovery fluid can bc determined. Once the bioburden is known, fmional-run smilizsrion stud~es n be perfomad to dttyrnine the micmbisl rare o a f kii1or process Icthaliry. In a fractional sterilization run, implant samples (in packaga) are exposed ta a hadion of the desirad

415

CnpywrnYW6bMhc*.bK.
M n g b a o l r e p ~ ly n
h d

**

IWIANT AND PACKAGING C O M P A ~ U T Y

The first mnccrn when choosing a srcrilization

ture rangt of 52" to 5 X , the tests must sarnpIcs exposed to a 570C p m . Also, the ~teril~zat~on exposures rpwt be considered in

sterilizaa'mcycle or dose. For example, if the propp~d process exposure t i m ~ 2 hr, the fractional nrns may have exposure is timuof 3440, md 50 min. Sampla frotn these runs are tested for sterility and the results plotted to determine the ~xposure time required to achieve a 10m6 SAL. The resulrs froom ouch a study are shown in F 2 In thh example, the average biobure . den pet sample was 240.After h e 30-, and SO-min frac44-, tional cycks, there were, rcspectiveiy, 28150. 7/50, aad 1/50 samples tbat were still rlofistwilt. ThecalcuIatcdtime to achieve a 10-' SAL for r h s hypothdcal bioburdm and sterilization pmecssisapproximately 100 min, which is within the proposed 120-min -sun time. Note that when there i s less than one surviving o r m s m per unit, therr h obviously not 0.01 ofan organism on each unit, for cxampk but a probability of 1 in 100 thin rhc unit is nonsterilc.

OVMVEW O STEltlUZATlON MmfODS F

The first sttrriizarion method to be used for implants was autoclaving, which tnvolvss exposure to saturated steam under pressure. Owing to the relatively high teniperature of the praccss (121C), nonmetallgc inlplants and packaging materimast alscatlnot bc sterilized by thism~thod.Th~s limitation Ird to t h e development and use ofethylene oxide (Fa) and lorltzing gas

n6. Z .
rlon

runs. Time w achaue a

Mimblr[ kltl c u r v t ~ J o n d l t a f m n dfncrirrn*lsdb I O d a S A t is apprammatdy 1W m h