Aami Tir28 2016

Technical
Information
Report
AAMI TIR28:
2016
Product adoption and
process equivalence for
ethylene oxide sterilization
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AAMI Technical Information Report AAMI TIR28:201 6
(Revi si on of AAMI TI R28: 2009/(R)201 3)
Product adoption and process equivalence for

Approved 1 8 N ovem ber 201 6 by

AAMI
Abstract: Th i s techn i cal i n form ati on report provi d es g u i d an ce for th e ad opti on of new or m od i fi ed prod u cts
i n to an exi sti n g val id ated steri l i zation process an d for th e d eterm i n ati on of eq u i val en ce of a
steril i zation process as con d u cted wi th d i fferen t eq u i pm en t. Gu i d an ce i s i n tend ed to au g m en t the
AN SI /AAM I /I SO 1 1 1 35 seri es i n th e areas of prod u ct ad opti on an d process eq u i val en ce.
Keywords: steril i zation , eth yl ene oxi d e, prod u ct ad option , process eq u i val ence, prod u ct fam i l y
AAMI Technical Information Report
A tech n i cal i n form ation report (TI R) is a pu bl icati on of th e Associati on for the Ad van cem en t of Med i cal
I n stru m en tation (AAM I ) Stan d ard s Board th at ad d resses a parti cu l ar aspect of m ed i cal tech n ol og y.
Al th ou g h th e m ateri al presen ted in a TI R m ay n eed fu rth er eval u ati on by experts, rel easin g th e i nform ati on is
val u abl e becau se th e i n d u stry an d th e professi on s h ave an im m ed i ate n eed for i t.
A TI R d i ffers marked l y from a stan d ard or recom m end ed practi ce, and read ers sh ou l d u n d erstan d th e d i fferen ces
between th ese d ocu m en ts.
Stan d ard s an d recom m en d ed practices are su bj ect to a form al process of com m i ttee approval , pu bl i c revi ew, an d
resol u ti on of al l com m en ts. Th i s process of con sensu s i s su pervi sed by th e AAMI Stan d ard s Board an d , i n th e case
of Am eri can N ati on al Stan d ard s, by th e Am eri can N ati on al Stan d ard s I n sti tu te.
A TI R i s n ot su bj ect to th e sam e form al approval process as a stan d ard . H owever, a TI R i s approved for d i stri bu ti on
by a tech n i cal com m i ttee an d th e AAMI Stan d ard s Board .
An oth er d i fference i s th at, al th ou g h both stan d ard s an d TI Rs are peri od ical l y reviewed , a stan d ard m u st be acted
on —reaffi rm ed , revi sed , or wi th d rawn —an d th e acti on form al l y approved u su al l y every fi ve years bu t at l east every
1 0 years. For a TI R, AAMI con su l ts wi th a tech ni cal com m i ttee abou t fi ve years after th e pu bl i cati on d ate (and
peri od i cal l y th ereafter) for g u id an ce on wh eth er th e d ocu m en t i s stil l u sefu l —th at i s, to ch eck th at th e i n form ati on i s
rel evan t or of h istorical val u e. I f th e i n form ati on i s n ot u sefu l , th e TI R i s rem oved from ci rcu l ati on .
A TI R m ay be d evel oped becau se i t i s m ore responsi ve to u n d erl yin g safety or perform an ce i ssu es th an a stan d ard
or recom m en d ed practi ce or becau se ach i evin g con sen su s is extrem el y d i ffi cu l t or u n l i kel y. U n l i ke a stan d ard , a TI R
perm i ts th e in cl u si on of d i fferi n g vi ewpoi n ts on techn i cal i ssu es.
CAUTION NOTICE: Th i s AAM I TI R m ay be revi sed or wi th d rawn at an y tim e. Becau se i t ad d resses a rapi d l y
evol vi n g fi el d or tech n ol og y, read ers are cau ti on ed to en su re th at they h ave al so con si d ered i n form ation th at m ay be
m ore recen t than th i s d ocu m en t.
Al l stan d ard s, recom m en d ed

practices, tech n ical i n form ati on reports, an d oth er types of techn ical d ocu m en ts
d evel oped by AAMI are
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, and th eir appl i cati on i s sol el y wi th i n th e d i screti on an d professi on al ju d gm en t of the
u ser of th e d ocu m en t. Occasi on al l y, vol u n tary tech n ical d ocu m ents are ad opted by govern m ent regu l atory ag en cies
or procu rem ent au th oriti es, in wh i ch case th e ad opti n g ag ency i s responsi bl e for enforcem ent of i ts ru l es and
reg u l ati on s.
Com m en ts on th is tech ni cal i nform ati on report are i n vi ted and sh ou l d be sent to AAMI , Attn : Stan d ard s Departm en t,
AAMI , 4301 N . Fai rfax Dri ve, Su i te 301 , Arl i ng ton , VA 22203-1 633.
Published by
AAMI
4301 N . Fai rfax Dr. , Su i te 301
Arl i n g ton , VA 22203-1 633
www. aam i . org
© 201 7 by th e Associ ati on for th e Ad van cem en t of M ed i cal I n stru m en tati on
Al l Ri gh ts Reserved
Pu bl ication , reprod u cti on , ph otocopyi ng , storag e, or tran sm i ssi on, el ectron i cal l y or oth erwi se, of al l or an y part of th is
d ocu m ent wi th ou t th e pri or wri tten perm i ssi on of th e Associ ati on for th e Ad vancem en t of Med i cal I nstru m en tati on i s
strictl y prohi bited by l aw. I t i s i l l eg al u n d er fed eral l aw (1 7 U . S. C. § 1 01 , et seq. ) to m ake copi es of al l or an y part of
th i s d ocu m en t (wh eth er i n tern al l y or extern al l y) wi th ou t th e pri or wri tten perm i ssi on of th e Associ ati on for th e
Ad van cem en t of Med i cal I n stru m en tati on . Vi ol ators ri sk l eg al acti on , i ncl u d i n g ci vil an d cri m i n al pen al ties, an d
d am ag es of $1 00, 000 per offen se. For perm i ssi on reg ard i n g th e u se of al l or an y part of th i s d ocu m en t, com pl ete th e
repri n t req u est form at www. aam i . org or con tact AAMI at 4301 N . Fai rfax Dri ve, Su i te 31 0, Arl i n g ton , VA 22203-1 633.
Ph on e: (703) 525-4890; Fax: (703) 276-0793.
Pri n ted i n th e U ni ted States of Am erica
ISBN 978-1 -57020-654-2

Contents Page
Glossary of equivalent standards ......................................... ................................................... ...................................... iv

Committee representation .................................... ................................................... ................................................... .... v
Foreword .......................................... ................................................... ................................................... ...................... vii
1 Scope ............................................. ................................................... ................................................... ................... 1
2 Terms and definitions ....................................... ................................................... ................................................... . 1
3 Product adoption .......................................... ................................................... ................................................... ..... 2
3.1 Establishment of an EO product family ................................................... ................................................... .. 2
3.2 Establishment of EO processing category ................................................... ................................................ 3
3.3 Evaluation for product adoption ................................................... ................................................... ............. 3
3.3.1 Determination of adverse effects ................................................... ................................................ 3
3.3.2 Determination of product design effects............................................ ............................................. 3
3.3.3 Determination of product material and characteristics effects........................................... ............. 3
3.3.4 Determination of sterile barrier system effects ........................................... .................................... 4
3.3.5 Determination of load configuration effects ........................................... ......................................... 4
3.4 Conclusions of product adoption evaluation ........................................ ................................................... ...... 4
3.4.1 Comparative resistance study............................................. ................................................... ........ 4
3.4.2 Temperature and humidity distribution study ................................................... .............................. 5
3.4.3 Residual study ................................................... ................................................... ......................... 5
3.5 Maintenance of EO product adoption .......................................... ................................................... .............. 5
3.6 Documentation ..................................... ................................................... ................................................... .. 5
4 Process equivalence ....................................... ................................................... ................................................... .. 6
4.1 General ................................................... ................................................... .................................................. 6
4.2 Requirements of process equivalence ................................................... ................................................... ... 6
4.3 Determination of process equivalence ................................................... ................................................... ... 6
4.3.1 Process analysis and evaluation ........................................ ................................................... ......... 6
4.3.2 Microbiological evaluation ........................................ ................................................... ................... 8
4.3.3 Results evaluation ................................................... ................................................... ................... 8
4.4 Process requalification and maintenance of equivalence....................................... ...................................... 8
4.5 Documentation ..................................... ................................................... ................................................... .. 8
Annex A Guide for evaluation of a product for adoption into an EO product family or
EO processing category .......................................... ................................................... ................................ 1 0
Bibliography ................................................... ................................................... ................................................... ........ 1 2
Glossary of equivalent standards
I n tern ati on al Stan d ard s ad opted in th e U n i ted States m ay i n cl u d e n orm ati ve referen ces to oth er I n ternati on al
Stan d ard s. AAMI m ai n tain s a cu rren t l ist of each I n ternati onal Stand ard th at h as been ad opted by AAMI (an d AN SI ).
Avai l abl e on th e AAM I websi te at th e ad d ress bel ow, th i s l ist g i ves th e correspon d in g U . S. d esi g n ati on an d l evel of
eq u i val en cy to th e I n tern ati on al Stan d ard .
www.aami.org/standards/glossary.pdf
iv © 201 7 Associ ati on for th e Ad van cem en t of Med i cal I nstru m en tati on  AAMI TI R28: 201 6
Committee representation
Association for the Advancement of Medical Instrumentation
Industrial Ethylene Oxide Sterilization Working Group
Th i s techn i cal i nform ati on report (TI R) was d evel oped by th e AAMI I n d u stri al Eth yl en e Oxi d e Steri l i zati on Worki n g
Grou p u n d er the au spices of th e AAMI Steri l i zati on Stan d ard s Com m ittee. Worki n g Grou p approval of th e TI R d oes
n ot n ecessari l y i m pl y that al l com m i ttee m em bers voted for i ts approval .
At th e ti m e th i s d ocu m en t was publ ish ed , th e AAMI Industrial Ethylene Oxide Sterilization Working Group h ad
th e fol l owi n g m em bers:
Cochairs: J on ath an Bu l l , J oh nson & J oh n son

J effrey Marti n , Steri l i zati on and Qu al ity System Con su l ti n g
Members: Erin Armstron g, B Braun Medical

Ed ward Arscott, N AMSA
David Ball ard, Dynatec Scientific Labs
Stacy Bohl , Boston Scien ti fic Corporati on
An n e F. Booth , M S, Booth Scien ti fi c
Carol yn Brai th wai te-N el son , Spectran eti cs
J on ath an Bu l l , J oh nson & J oh n son
Ti m Carl son , B D Med i cal
Sarah Ch am berl ai n , Accu ratu s Labs Sol u ti on s
Den n is Ch ristensen , BS, Steri l i zati on Val i d ation & Con su l tin g
Gary N . Cran ston, Con su l ti n g & Tech n ical Servi ces/PCS
El ai n e Dan iel l , Bard Med i cal Di vi si on
Dou g l as D. Davi e, Steri l i zati on Val i d ati on Servi ces
Darci Diag e, Di rect Fl ow M ed i cal
Davi d Di on , Card i n al H eal th
Mary An n Drosn ock, MS, H eal th m ark I n d u stri es
Pau l Fi ori ti , PF Qu al i ty Con su l ti n g
Wil l i am F. Fi tzGeral d , PE, Fi tzG eral d & Associ ates Ltd .
Dan B. Fl oyd , RM , Du pon t Protecti on Sol u tion s
Li sa Foster, Ad i u vo QS & SA Con su l ti n g
Matth ew Freem an , Teru m o BCT
Zory R. Gl aser, Ph D M PH CS PD M, J oh n s H opki ns U n i versi ty
Mi ch ael Groen d yk, Arth rex
Dou g l as H arbrech t, Steri l ity Assu rance
Arth u r C. H arri s, Cook
Deborah A. H avl ik, H ospi ra, a Pfi zer Com pan y
J ason H ed ri ck, Med tron ic
Cl ark W. H ou g h tl in g , Cosm ed G rou p
Kri sta H oward , WL Gore & Associ ates
N ai pu r J ai n , I ntu i ti ve Su rgi cal
Carol yn L. Ki n sl ey, LexaMed
Karen A. Kowal czyk, Cen tu ri on Steril i zati on Services
Ch ri sti n e Losh bau g h , Ed ward s Li feSci en ces
Mol l i e Love, Sm i th s M ed i cal
J effrey Marti n , Steri l i zati on and Qu al ity System Con su l ti n g
Al bert May, An d ersen Prod u cts I n c.
Patri ck McCorm i ck, Ph D, Bau sch & Lom b
Davi d Ford M cGol d ri ck, BS, Abbott Vascu l ar Devi ces
Ru ssel l D. Mi l l s, GE H eal th care
Gerry A. O’ Del l , M S, Gerry O’ Del l Consu l ti ng
Dave Paren te, ECOLAB H eal th care
Mi ch el l e Peterson , Stryker I nstru m en ts
An d rew Porteou s, Baxter H eal th care
N an cy Raki ewi cz, I U VO B i oSci en ce
Kei th Rei n er, Teru m o Card i ovascu l ar System s
Beth Ri d g eway, Mesa Laboratori es
Man u el Saaved ra J r. , H al yard H eal th
H arry Sh affer, Steri l i zati on Con su l ti n g Servi ces
© 201 7 Associ ati on for th e Ad van cem en t of Med i cal I nstru m en tati on  AAMI TI R28: 201 6 v
Arn ol d Sh ech tman , BS, Val id ati on Chal l en g es Con su l ti ng
Davi d Si l or, Zi m m er
B i l l Sou th , I som ed i x Servi ces
Mi ch ael G. Sprag u e, Eth i d e Laboratori es
Soph eak Sru n , M PH S M(N RCM), Qu al i ty Tech Servi ces
Fen i l Su tari a, Med l i n e I n d u stries
Mara Tafoya, Wu Xi AppTec
Rad h akri sh n a S. Ti ru m al ai , U S Ph armacopei al Con ven ti on
Steven E. Tu rti l , FDA/CDRH
Crai g A. Wal l ace, 3M H eal th care
P. Ri ch ard Warbu rton , Ch em DAQ
Ri ch ard L. Wei sm an , Fresen i u s Med i cal Care
B everl y Whi taker, CQA RAB M B A, I n d i g o Con su l ti n g Grou p
Den n is L . Wi l d es, St. J u d e M ed i cal
Wil l i am T. You n g , Sterig en i cs I n tern ati on al
Roberto Zu m bad o, Sr. , Ph i l i ps
Alternates: Au g u st Bau r, Cen tu ri on Steri l i zati on Servi ces

M arJ ean Boyter, Fresen i u s M ed i cal Care
Robert Brad l ey, CB E T, M esa Laboratori es
Trabu e D. Bryan s, B ryCor
G reg B u sh , Al con Research
Li za Ch en ette, Accu ratu s Labs Sol u ti on s
Sean N . Col wel l , Wu Xi Apptec
Al l i son Di em ert, Arth rex
D avi d D om i n g u ez, B ecton D i cki n son
Bri an Dru m h el l er, B rookh aven M ed i cal
Ven i ce E l d red , M ed l i n e I n d u stri es
Steven El l i ott, FDA/CDRH
D i an e Fai vre-Swi at, Card i n al H eal th
M ark Fi n l ey, Boston Sci en ti fi c
N aom i G am m , St. J u d e M ed i cal
Scott G i rau d , M ed tron i c Card i ac Su rg i cal Prod u cts Wi l l i am
K. G ord on , Steri s I som ed i x Servi ces
D avi d M . H i l l i ker, Ch em Daq
B ren t H u berty, Boston Sci en ti fi c
N i col e J ackson , Ecol ab
Satu Ki n g , Spectran eti cs
Ch ri s Kobu s, G E H eal th care
Ezra Koski , Teru m o BCT
J am es P. Ku l l a, BS M S, LexaM ed
Wesl ey Lan tz, Zi m m er
J oh n Li n d l ey, An d ersen Prod u cts I n c.
Pau l L. Li ttl ey, BSE , N el son Laboratori es
M au ri ci o M arti n ez, Sm i th s M ed i cal
N i col e M . M cLees, 3M Cri ti cal & Ch ron i c Care Sol u ti on s
J oseph M el l o, Eth i d e Laboratori es
Lau ri e N awrocki , N AM SA
Koyej o Obad i n a, Abbott Vascu l ar
Ken Pad d ock, Baxter H eal th care
M i ch ael A. Pad i l l a, Steri Pro Labs
Tyron e S. Rou se, H al yard H eal th
M i ch ael Sh oen e, Bau sch & Lom b
Kri sten Spi g i el , Stryker I n stru m en ts
E l i zabeth Stei n er, I U VO Bi oSci en ce
B ri an Wal l ace, I n tu i ti ve Su rg i cal
Scott Wei ss, Eth i con
D aryl Wood m an , An d ersen Prod u cts
Casi m i r J oh n Wos, Ph D , Fi tzG eral d & Associ ates
N OTE—Parti ci pation by federal ag en cy representatives i n th e d evel opm en t of thi s techn ical in form ati on report d oes n ot
constitu te en d orsemen t by the fed eral govern ment or an y of its agencies.
vi © 201 7 Associ ati on for th e Ad van cem en t of Med i cal I nstru m en tati on  AAMI TI R28: 201 6
Foreword
Th i s d ocu m en t is part of a seri es of tech ni cal i n form ati on reports (TI Rs) i n ten d ed for u se in con j u n cti on wi th
AN SI /AAMI /I SO 1 1 1 35: 201 4. Th e oth er reports i n th e seri es are
− AAMI TI R1 4: 2009, Con tract steri l i zati on u sin g eth yl ene oxi d e;
− AAMI TI R1 5: 2009, Eth yl en e oxi d e steri l i zati on eq u i pm en t, process con si d erati on s, and perti n en t cal cu l ati on s
(cu rren tl y u n d er revisi on );
− AAMI TI R1 6: 2009, Process d evel opm en t an d perform an ce q u al i fi cati on for eth yl en e oxi d e steril i zation —
Mi crobi ol ogi cal aspects (cu rren tl y u n d er revi si on ); and
− AAMI TI R56: 201 3, Gu id ance for th e d evel opm en t, val i d ati on an d rou ti n e con trol of an eth yl en e oxi d e
steril i zation process u til i zi n g fl exi bl e bag system s for the steri l i zation of m ed ical d evi ces
Th e ori g in al TI R28, al on g wi th oth er AAMI TI Rs, provi d ed ad d i ti on al g u id ance to th e 1 994 ed i tion of the i n d u stri al EO
steril i zation stan d ard 1 1 1 35, wh i ch was revi sed i n 2007 u n d er a n ew d esig n ati on , AN SI /AAM I /I SO 1 1 1 35-1 : 2007,
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and
routine control of a sterilization process for medical devices. I n 2008, I SO pu bl i sh ed i ts own g u i d an ce d ocu m ent for
th e 1 1 1 35 stan d ard , I SO/TR 1 1 1 35-2: 2008, Sterilization of health care products - Ethylene oxide - Part 2: Guidance
on the application of ISO 11135-1 , wh i ch was based to a g reat exten t on th e earl i er AAMI tech n i cal i nform ati on
reports. Correspon d i n gl y, th e AAMI I n d u stri al EO steri l i zati on worki n g g rou p is u pd ati n g i ts TI Rs to take i n to accou n t
ch ang es to th e 1 1 1 35 stan d ard .
Th i s TI R provi d es g u i d an ce for th e ad opti on of n ew or m od i fied prod u cts i n to an exi sti n g val i d ated steril i zati on
process an d for th e d eterm i nati on of eq u i val en ce of a steri l i zati on process as con d u cted wi th d i fferen t eq u i pm en t.
Th ese areas are n ot ad d ressed i n d epth by AN SI /AAMI /I S O 1 1 1 35: 201 4, bu t th ey are im portan t i n d u stry practices
th at are u sed to red u ce th e expen se an d tim e associated wi th th e val i d ati on or req u al i fication of an eth yl en e oxi d e
steril i zation process an d are based on accu m u l ated process kn owl ed g e.
Th e ad opti on of a n ew or m od i fi ed prod u ct i n to an exi sti n g val i d ated steri l i zati on process i n vol ves th e d eterm i n ati on
th at th e prod u ct is n o m ore of a chal l en g e th an th e prod u ct (i. e. , m aster prod u ct or represen tati ve prod u ct) or process
ch al l en g e d evi ce th at was u sed i n th e perform an ce q u al i fication for th e eth yl en e oxi d e steri l izati on process.
Th e process eq u i val ence secti on of th i s TI R wi l l provi d e g u i d an ce on h ow to establ i sh eq u i val en ce between

processes perfom ed in separate eq u i pm en t or sets of eq u i pm en t an d g u i d an ce on the l evel of m i crobi ol ogi cal
perform an ce q u al i fi cati on testi n g req u i red . It al so i ncl u d es g u i d an ce on th e m ain tenan ce of eq u i val en ce an d
req u al i ficati on wh en eq u i val ence has been establ i shed .
Th i s TI R con tai n s g u i d el i nes th at are n ot i n ten d ed to be absol u te or to appl y i n al l ci rcu m stan ces. On e shou l d u se
j u d gm en t i n appl yi n g th e in form ation i n th i s TI R.
As u sed wi th i n th e con text of th i s d ocu m en t, “sh ou l d ” in d i cates th at am on g several possibi l i ti es, on e i s recom m end ed
as parti cu l arl y su itabl e, wi th ou t m enti on i n g or excl u d in g oth ers, or th at a certai n cou rse of action is preferred bu t n ot
n ecessari l y req u i red , or th at (i n th e n egati ve form ) a certai n possi bi l i ty or cou rse of acti on sh ou l d be avoi d ed bu t is
n ot proh i bited . “May” i s u sed to i n d icate th at a cou rse of acti on i s perm i ssibl e wi th i n th e l im i ts of th e recomm en d ed
practi ce. “Can ” is u sed as a statem en t of possibi l i ty and capabi l i ty. Fi n al l y, “m u st” is u sed on l y to d escri be
“u n avoi d abl e” situ ati ons, i n cl u d i n g th ose m an d ated by g overn m en t reg u l ati on . See al so the N OTE on Pag e 1 .
Su g g esti on s for im provi n g th i s tech n ical in form ation report are i n vi ted . Com m ents an d su g g ested revi si on s sh ou l d be
sen t to AAM I , 4301 N . Fai rfax Dri ve, Su i te 301 , Arl in g ton , VA 22203-1 633.
N OTE—Thi s foreword d oes n ot contain provisi ons of the AAMI TI R28: 201 6 titl ed Product adoption and process
equivalence for ethylene oxide sterilization , bu t i t d oes provi d e im portant in form ati on abou t th e d evel opment an d
intend ed u se of the d ocum en t.
© 201 7 Associ ati on for th e Ad van cem en t of Med i cal I nstru m en tati on  AAMI TI R28: 201 6 vi i
viii © 201 7 Association for the Advancement of Medical Instrumentation  AAMI TIR28:201 6
AAMI Technical Information Report AAMI TIR28:201 6
Product adoption and process equivalence for

N OTE —Thi s tech n ical i nform ati on report i s n ot a stan d ard an d th e m ateri al contai n ed h erei n i s n ot n orm ati ve i n n atu re. The
com m i ttee h as i n a few pl aces used th e term "sh al l " based on thei r kn owl ed g e of req u i rem en ts con tai n ed i n rel evan t stan d ards
an d /or reg u l atory req u i rem ents.
1 Scope
Th i s TI R ad d resses m ed i cal d evi ces th at are processed by eth yl en e oxi d e (EO) steri l i zati on u si ng con ven ti onal or
param etric prod u ct rel ease. The d ocu men t appl i es to th e fol l owi n g si tu ati on s for the steri l i zati on of m ed ical d evi ces:
a) a n ew prod u ct is bei n g ad d ed to th e previ ou sl y val id ated process,
b) ch ang es to val i d ated prod u cts are bei n g eval u ated ,
c) a previ ou sl y val id ated process i s bei ng moved to a d i fferen t faci l i ty or to d i fferen t eq u i pm ent, an d
d) eq u i val en cy of a steri l i zati on process i s bei ng eval u ated .
Al th ou g h th e i n form ati on presen ted was d evel oped for appl i cati on to m ed i cal d evi ces, th e con ten t of thi s g u i d el i ne
m ay al so be appl ied to other rel evan t prod u cts or m ateri al s.
2 Terms and definitions

For th e pu rposes of thi s AAMI TI R, th e fol l owi n g term s an d d efi n iti on s appl y:
2.1
candidate equipment
n ew or m od ifi ed piece of eq u ipm en t i n ten d ed to d el i ver an exi sti ng val i d ated process.
2.2
candidate product
n ew or m od i fi ed prod u ct, i n cl u d i n g th e packag i n g system , proposed for in cl u sion i n th e exi sti ng val i d ated steri l i zati on
process.
2.3
EO processing category
col l ecti on of d i fferen t prod u ct or prod u ct fam il i es th at can be steri l i zed togeth er (i n th e sam e EO steri l i zati on process).
N OTE —Al l prod u cts wi th i n th e processi n g categ ory h ave been d eterm i n ed to presen t an eq ual or l esser ch al l en g e to th e
steri l i zati on process th an th e ch al len g e d evi ce for th at categ ory.
2.4
EO product family
g rou p of prod u cts possessin g ch aracteri sti cs that al l ow th em to be steri l i zed u si n g th e same d efi ned process
con d i ti on s an d d eterm i n ed to be si m il ar or eq u i val en t for val i d ati on pu rposes.
2.5
load configuration
total i ty of attri bu tes d efi n i n g the presen tati on of th e prod u ct to th e steri l i zati on process. Th is con fi gu ration in cl u d es (a)
th e orien tati on of th e prod u ct wi th i n th e steri l e barri er system (prim ary packag e); (b) th e q u an ti ty an d ori en tati on of
th e prim ary packag e wi th i n th e protecti ve packag i ng (second ary or terti ary packag e); (c) the q u an ti ty, ori en tati on , an d
pl acem en t of th e prod u ct i n th e protecti ve packag i n g on th e steri l i zer pal l ets (or wi th i n th e carri ers); and (d ) th e
q u an ti ty an d pl acem en t of th e pal l ets (or carri ers) wi th i n th e vessel or area.
© 201 7 Associ ati on for th e Ad van cem en t of Med i cal I nstru m en tati on  AAMI TI R28: 201 6 1
2.6
packaging system
combi n ati on of th e steri l e barrier system an d protecti ve packag i n g.
2.7
process equivalence
d ocu m ented eval u ati on th at th e sam e steri l i zati on process can be d el i vered by two or m ore pi eces of steri l i zati on
process eq u i pm en t wi th i n d efin ed param eters.
2.8
product adoption
process of form al l y i ncl u d i n g a can d i d ate prod u ct i n to an exi sti n g val id ated EO processi n g categ ory or EO prod u ct
fam i l y.
2.9
sterilization process equipment
precon d i ti on i n g area (i f u sed ), ch am ber or steri l i zer, aerati on area (if u sed ), an d th ei r respecti ve anci l l ary eq u i pm en t.
3 Product adoption
Th e term u su al l y associ ated wi th th e i n trod u ction of a n ew or m od i fi ed prod u ct (cand i d ate prod u ct) i n to a val i d ated
steril i zation process is “prod u ct ad opti on. ” Prod u ct ad option h as trad i ti on al l y been u sed to red u ce th e l evel of
perform ance q u al ifi cati on (PQ) req u i red by g rou pi n g prod u cts i n to ei th er EO prod u ct fam il i es or EO processi n g
categ ori es. Th i s TI R d escri bes th e i m portan t aspects to th e approach for prod u ct ad opti on , wh i ch al so i ncl u d es the
establ i sh m en t of EO prod u ct fam i l i es an d EO processi n g categ ori es an d th e recom m end ed m ai n ten ance of th ose
fam il i es an d categ ori es.
3.1 Establishment of an EO product family
Prod u cts m ay be g rou ped in to EO prod u ct fam i l i es on th e basi s of si m i l ari ties i n con fig u rati on , m ateri al s, d en si ty,
packag in g , or d i ffi cu l ty of steri l izati on .
Th e fol l owi n g l i st provi d es g u id an ce on th e el em en ts th at m ay be con si d ered wh en pl acin g prod u cts i nto EO prod u ct
fam il i es:
a) prod u ct d esig n an d fu n cti on ,
b) m an u factu ri n g m eth od ,
c) m an u factu ri n g en vi ron m en t or area,
d) m ateri al of con stru cti on ,
e) packag in g m ateri al s,
f) steri l e barri er or protecti ve packag in g con fi g u rati on ,
g) d en si ty,
h) si ze and /or su rface area, and
i) bi obu rd en .
An EO prod u ct fam il y m ay con sist of vari ou s com bi n ati ons of sim i l ar prod u cts. For exam pl e, an E O prod u ct fam i l y
m ay con tai n a seri es of cath eters that d i ffer onl y i n th ei r si zes; a vari ety of prod u cts th at are m ad e i n th e sam e
en vi ron m en t wi th th e sam e m ateri al ; or kits th at con tai n variou s com bi n ation s of spong es, bowl s, i nstru m en ts, towel s,
d rapes, an d oth er i tems, an d wh i ch d i ffer wi th i n a fam i l y on l y i n th e types, q u an ti ti es, an d si zes of i tem s i ncl u d ed
wi th i n th e ki ts. Th e EO prod u ct fam i l y m ay be represented by a worst-case prod u ct (often cal l ed th e “m aster
prod u ct”), or th e en ti re fam i l y is con si d ered an eq u i val en t chal l en g e to th e steril i zati on process and an y prod u ct wi th i n
th e fam i l y can represen t the fam i l y, or th e prod u ct fam i l y can be represen ted by a process ch al l en g e d evi ce (PCD).
Th e represen tati ve prod u ct or PCD wou l d th en be u sed as th e basi s for com parison of an y can d i d ate prod u ct (see
AN SI /AAMI /I SO 1 1 1 35: 201 4 (D. 1 2. 5. 1 1 . 1 ).
2 © 201 7 Associati on for th e Ad van cemen t of Med i cal I n stru m en tati on  AAM I TI R28: 201 6
3.2 Establishment of an EO processing category
An EO processin g categ ory i s a col l ecti on of EO prod u ct fam il i es th at can be d i ssi m i l ar i n th e d etail s u sed to establ i sh
th e EO prod u ct fam i l y, su ch as m ateri al of con stru cti on or packag i ng , bu t each of th e EO prod u ct fam i l i es wi th i n an
EO processin g categ ory can be q u al i fi ed i n a com m on steri l i zati on processs. . For exam pl e, a col l ecti on of prod u cts
(i n traven ou s sets) can consti tu te an EO prod u ct fam il y an d can be pl aced i n an EO processi n g categ ory that i n cl u d es
a separate col l ecti on of prod u cts (e. g . , a fam i l y of syri n ges). Th e com m on al i ty wi th i n th e EO processi ng categ ory m ay
be the i n ternal process ch al l en g e d evi ce (I PCD) th at represen ts th e m i crobi al chal l en g e for th ose prod u cts i n that
categ ory. Al l prod u cts wi th i n th i s EO processi n g categ ory sh ou l d presen t an eq u i val en t or l esser chal l en g e to the
steril i zation process wh en com pared wi th th e worst-case prod u ct, represen tati ve m em ber, or I PCD.
Grou pi n g of prod u cts can al so be benefici al wh en based on attri bu tes su ch as EO resid u al s, bi obu rd en , or
bi ocom pati bi l i ty.
3.3 Evaluation for product adoption
A tech n i cal revi ew sh ou l d be performed com pari n g th e can d i d ate prod u ct wi th the cu rren tl y val i d ated prod u ct or PCD
th at was u sed to val i d ate th e exi sti n g EO process. Th i s review m ay be con d u cted for each EO prod u ct fam i l y or EO
processi n g categ ory. Al tern ati vel y, a worst-case prod u ct or represen tati ve m em ber m ay be sel ected for th e
q u al i fication stu d y. Eval u ation typi cal l y consists of th e fol l owi n g steps:
1 ) I d en ti fy d i fferen ces between th e can d i d ate prod u ct and th e cu rren tl y val i d ated prod u ct. An n ex A i s a g u i d e th at can
be u sed in th i s revi ew. An n ex A i s n ot al l -in cl u si ve; th ere can be oth er factors th at sh ou l d be con si d ered . Con versel y,
som e of th e i tem s m i gh t not appl y, d epen d i n g on th e can d i d ate prod u ct.
2) Determ i n e th e poten tial effects of the i d en ti fi ed d ifferen ces. Gu i d ance i s provi d ed i n section s 3. 3. 1 th rou g h 3. 3. 5.
3) I f th e effects of ch ang es are u n kn own , perform testin g to d eterm in e th e effects. Gu id an ce i s provi d ed i n Secti on s
3. 4. 1 th rou g h 3. 4. 3. N ote th at i t i s possi bl e for a can d i d ate prod u ct to be m ore d i fficu l t to steril i ze, h ave red u ced
pen etrati on of EO, h eat and h u m id i ty, an d /or retai n h i g h er l evel s of resi d u al s an d sti l l be i ncl u d ed i n th e prod u ct
fam i l y or processi n g categ ory as a n ew worst case (m aster or represen tati ve) prod u ct. I n th i s case i t m i gh t be
n ecessary to con d u ct fu rth er stu d i es as d escri bed i n 3. 4.
3.3.1 Determination of adverse effects
Before d eterm i ni n g wh ether a cand i d ate prod u ct or packag in g system can be ad opted i n to an EO prod u ct fam il y or
EO processi n g categ ory, on e sh ou l d d eterm in e wh eth er th e can d id ate prod u ct or packag in g system wi l l rem ai n
fu n cti onal an d effecti ve. A system to eval u ate these aspects sh ou l d be ad d ressed by th e d esi g n or ch an g e con trol
process. Con sid erati on sh ou l d be g i ven to fu nction al i ty, i n tegri ty, stabil i ty, biocom pati bi l i ty, an d resi d u al s, wi th speci al
consi d eration g i ven to d eterm in i n g th e effect th at th e steril i zati on process m i g h t have on d ru g s th at cou l d be i ncl u d ed
i n d evi ces or com pon en ts. For prod u cts th at con tai n certai n types of fi n ish ed com pon en ts (e. g . , ki ts wi th d ru g s), th e
m an u factu rer sh ou l d consi d er reg u l atory req u i rem en ts wi th reg ard to the safety an d effi cacy of th ese com pon en ts i n
ad d i ti on to the im pact th e steril i zati on process can h ave on the expi ry d ate of th e prod u cts in vol ved .
Th e EO process for wh i ch th e prod u ct wi l l be tested sh ou l d con sti tu te a represen tati ve ch al l en g e (u si n g the m ost
ch al l eng i ng process param eters) to th e prod u ct an d i ts packag i n g system . Th i s req u i rem en t i s d etai l ed wi th i n 7. 2. 1 of
AN SI /AAM I /I SO 1 1 1 35: 201 4. Docu men tati on sh ou l d ad d ress h ow th e chal l en g e process d i ffers from th e n om i nal
process, an d th e prod u ct q u al i ficati on sh ou l d d em on strate th at th e prod u cti on param eters resu l t in acceptabl e
prod u ct. .
3.3.2 Determination of product design effects
Th e d esi g n of th e can d i d ate prod u ct sh ou l d be carefu l l y reviewed for an y ch an g es or d i fferen ces that cou l d presen t
g reater obstacl es to EO, h eat, or h u m id i ty pen etrati on th an th e exi sti n g prod u ct or PCD. E xam pl es of possi bl e
ch an g es i n cl u d e l on g er l u m en s, th e ad d i tion of cl osu res, or a l arg er n u m ber of m ated su rfaces.
Revi ew th e prod u ct d esi g n ag ai nst th e orig i nal prod u ct fu n ction al i ty testi n g to ensu re th at th e ch an g es d o n ot
ad versel y affect the fu nction of th e prod u ct.
N OTE —Thi s eval u ati on typi cal l y d oes n ot i n cl u d e areas of th e d evi ce th at are h erm etical l y seal ed an d can n ot be exposed d u ri n g
i n ten d ed u se. E xam pl es are item s su ch as seal ed, h ol l ow, m ol d ed parts or seal ed l um ens.
3.3.3 Determination of product material and characteristics effects

Th e ch aracteristics of th e can d i d ate prod u ct sh ou l d be carefu l l y exam i n ed for an y d i fferen ces th at cou l d poten ti al l y
affect th e prod u ct bi obu rd en , su ch as m an u factu ri n g prod u cti on m eth od s, faci l i ti es, l ocati on , an d raw m ateri al types
an d sou rces. Th e m ateri al s of con stru cti on sh ou l d be revi ewed to ensu re th at th e prod u ct wi l l n ot retai n h i gh er
resi d u al l evel s or l evel s that wi l l exceed th e reg u l ated l im i ts. I n form ati on on EO m ateri al com pati bil i ty can be fou n d i n
AAMI TI R1 7 as wel l as th rou gh ou t l i teratu re. Based u pon the i n form ati on gath ered , th e d ata wi l l d efi n e th e poten ti al
for prod u ct ad option or i d en ti fy th e need for fu rth er stu d y.
3.3.4 Determination of sterile barrier system effects
Th e steri l e barri er system of th e can d i d ate prod u ct sh ou l d be carefu l l y exam i n ed for an y factors th at cou l d presen t
obstacl es to EO, h eat, or h u m id i ty penetration . Th ese factors can be a d ecrease i n porosi ty of th e ven ti ng m aterial , a
sm al l er ven tin g su rface area, th e occl u si on of the ven ti n g area, or an y other featu re th at wou l d m ake th e can d i d ate
prod u ct a greater ch al l en g e to th e steri l i zati on process than th e exi sti n g prod u ct or i PCD. I n ad d i ti on , the steri l e
barri er system ch an g es sh ou l d be eval u ated for th e poten tial i m pact to prod u ct bi obu rd en an d th e poten ti al i m pact to
EO resi d u al s.
3.3.5 Determination of load configuration effects
Th e l oad con fi g u rati on of th e can d i d ate prod u ct sh ou l d be carefu l l y exam i n ed for an y chan g es th at cou l d affect th e
th ermod yn am i c respon se to th e steri l i zati on process. Th ese ch an g es cou l d i n cl u d e ad d i ti onal l ayers, a
recon fi g u ration of th e pal l et, a chan g e i n th e l oad si ze, a ch ang e to th e overal l d en si ty of th e l oad , or an y oth er
ch ang e th at wou l d m ake th e can d i d ate prod u ct a g reater ch al l en g e to th e steri l i zati on process. Th e effects of th e l oad
con fi g u rati on sh ou l d be eval u ated agai nst th e val i d ated l oad . I f th e n ew or m od i fi ed prod u ct l oad i s si g n ifi can tl y
d i fferen t th an th e cu rren tl y val id ated on e, i t m i gh t be n ecessary to con d u ct fu rth er stu d i es as d escri bed i n 3. 4.
3.4 Conclusions of product adoption evaluation
I f th e resu l ts of th e wri tten tech n i cal revi ew sh ow th at the can d i d ate prod u ct an d exi sti n g prod u cts or i PCD are si m il ar
an d th at th e d i fferen ces between th em are d eterm i n ed to be i nsi gn i fi can t or to present a l esser ch al l en ge th an th e
cu rrentl y val i d ated prod u ct or i PCD, th en th e can d i d ate prod u ct m ay be ad opted i n to th e EO prod u ct fam i l y or EO
processi n g categ ory wi th ou t fu rth er stu d y. I f An n ex A was u sed for th e revi ew, th i s d eci si on wou l d be su pported by
vi rtu al l y al l “N o” answers to the q u estions. Th e rati onal e for th i s d ecisi on sh ou l d be m ad e by a steri l i zati on speci al i st
an d sh al l be d ocu m en ted .
I f th e techn i cal revi ew i n d i cates that the can d i d ate prod u ct h as the poten tial to be a g reater chal l en g e to th e
steril i zation process th an th e cu rren tl y val i d ated prod u ct or iPCD, th en fu rth er stu d i es are i n d icated (see 3. 4. 1 , 3. 4. 2,
an d 3. 4. 3). I f th e cand i d ate prod u ct i s d eterm in ed to represen t a g reater ch al l en g e to th e steril i zation process, th en it
d oes n ot m eet th e req u i rem ents for ad opti on i nto an exi sti ng EO prod u ct fam i l y or EO processi n g categ ory, an d a PQ
sh al l be perform ed i n accord an ce wi th AN SI /AAMI /I SO 1 1 1 35: 201 4. Th i s PQ m ay:
a) establ ish a new EO prod u ct fam i l y or EO processi n g categ ory, wi th th e can d id ate prod u ct as th e represen tati ve
prod u ct;
b) establ ish a n ew i PCD for the exi sti n g steri l i zati on process;
c) establ ish th at th e can d i d ate prod u ct is represen ted by th e cu rren tl y val id ated m aster prod u ct;
d) establ ish a n ew steril i zation process for the can d id ate prod u ct; an d
e) establ ish wh eth er or n ot th e exi sti n g EO prod u ct fam il y or processi n g categ ory m em bers m ay be in cl u d ed i n th e
n ew E O prod u ct fam i l y or EO processi n g categ ory.
3.4.1 Comparative resistance study
A com parati ve resistan ce stu d y can be perform ed to eval u ate th e can d id ate prod u ct if the tech n i cal revi ew i n d icated
th at i t m i g h t presen t a g reater l eth al i ty ch al l en g e to th e steri l izati on process. Th i s stu d y i s con d u cted by perform in g at
l east on e fracti on al cycl e wi th repl i cates of th e can d i d ate prod u ct an d exi sti n g prod u ct or i PCD an d ePCD as
appl i cabl e to the stu d y d esi gn . I f th e resi stance of th e can d i d ate prod u ct d em onstrates an eq u al or l esser resi stan ce
th an d oes th e q u al i fi ed prod u ct or PCD, th en th e can d i d ate prod u ct can be ad opted i n to th e exi sti n g EO prod u ct
fam il y or EO processi n g category. Wh en th e can d i d ate prod u ct fail s to d em on strate an eq u al or l esser resi stan ce to
th e q u al ifi ed prod u ct, th en :
a) th e prod u ct can be pre-treated before steri l i zation to red u ce th e bi obu rd en n u m bers, or th e prod u ct, the process or
both can be eval u ated to d eterm i ne h ow to red u ce th e bi obu rd en n u m ber or resi stan ce (e. g . by ch an gi n g th e raw
m ateri al s or m an u factu rin g process u sed , by i m provi n g th e m an u factu ri ng en vi ron m ent, or by m od i fyi n g th e prod u ct
d esi g n ) (see AN SI /AAMI /I SO 1 1 1 35: 201 4 D. 8. 6) an d a comparati ve resistan ce stu d y repeated , or
b) at l east a m i crobi ol og ical PQ wou l d be req u i red .
N OTE —Com parati ve resi stan ce stu d i es associ ated wi th th e can d i d ate prod u ct an d PCD m ay be perform ed i n a pi l ot ch am ber.
Can d i d ate prod u cts th at affect th e presen tati on of th e l oad to th e steri l i zati on process sh ou l d be eval u ated to d eterm i n e th e effect in
a prod u cti on ch am ber versu s a pi l ot ch am ber.
3.4.2 Temperature and humidity distribution study

A tem peratu re an d h u m i d i ty d i stri bu tion stu d y m ay be perform ed to eval u ate th e can d i d ate prod u ct i f th e tech n i cal
revi ew i n d i cated that i t can affect the th erm od yn am i c respon se of th e l oad i n th e steri l i zati on process. Th i s stu d y i s
con d u cted by perform in g at l east one cycl e wi th tem peratu re an d h u m id i ty sen sors d i stri bu ted th rou g h ou t th e l oad in
a m an n er th at repl i cates th e ori g i n al PQ. I f th e tem peratu re an d hu m i d i ty respon se of th e can d i d ate prod u ct i s
com parabl e or d em on strates n o n egati ve i m pact to th e exi sti n g l oad , th en the can d id ate prod u ct can be ad opted i n to
th e exi sti ng EO prod u ct fami l y or EO processi ng categ ory. Wh en these resu l ts are n ot ach ieved i n th e l oad , th en :
a) th e prod u ct or packag in g or l oad con fig u rati on can be re-d esi g ned an d a tem peratu re an d h u m i d ity d i stri bu ti on
stu d y repeated , in cl u d in g consi d erati on of the effects on ad j acen t prod u cts i n th e l oad ; or
b) at l east a m i crobi ol og ical PQ wou l d be req u i red .
For prod u cts th at h ave tem peratu re or m oistu re restri cti on s, th e resu l ts of th e d i stri bu ti on stu d y m ay i n d i cate th at,
al th ou g h steri l i ty is n ot affected , fu rth er prod u ct q u al i fi cati on or chan g es to th e steri l i zati on process m ay be req u i red
to m eet th e restriction s. I n th ese cases, a PQ m ay be req u i red .
3.4.3 Residual study

A resid u al stu d y can be perform ed to eval u ate th e can d id ate prod u ct i f th e tech n ical review i n d i cated th at i t m i gh t
represen t a g reater ch al l en ge to rem oval of steri l an t resi d u al s. Th i s stu d y i s perform ed u sin g a fu l l steril i zation
process an d sh ou l d al so ad d ress m u l ti pl e steril i zati on s as appl i cabl e. I f the resu l ts of th e stu d y i n d i cate that th e
resi d u al s of th e can d id ate prod u ct are com parabl e to the exi sti n g prod u ct, th en n o fu rth er stu d y i s n ecessary. I f these
resu l ts are n ot ach i eved , th en a d eterm i nati on sh ou l d be m ad e as to h ow to q u al i fy th e can d i d ate prod u ct i n
com pl i an ce wi th AN SI /AAM I /I SO 1 0993-7. For pu rposes of establ ish i n g prod u ct fam i l i es an d processin g categ ori es,
aeration tim e m ay be consid ered separatel y from th e steri l izati on ph ase of th e process, th at i s, prod u cts m ay be i n
th e sam e steri l i zati on processin g category bu t d i fferen t aerati on categ ori es.
3.5 Maintenance of EO product adoption

Th e basis for th e creati on of an EO prod u ct fam i l y, EO processi n g categ ory, or prod u ct ad option sh ou l d con ti n u e to
rem ain val id . Th e con fi rm ati on of th e val id i ty sh ou l d occu r wh en a can d i d ate prod u ct assessm en t i s con d u cted , wh i ch
cau ses a revi ew of th e EO prod u ct fam i l y, EO processin g categ ory, or prod u ct ad opti on . Th e EO prod u ct fam i l y an d
EO processi n g categ ory sh ou l d be peri od i cal l y revi ewed . Th e peri od i c revi ew sh ou l d be d ocu m en ted at a speci fi ed
freq u en cy to en su re th at th e EO prod u ct fam i l i es an d EO processi n g category rem ai n val i d .
3.6 Documentation
Al l d eci si on s rel ated to th e ou tcom e of th e anal ysis to d eterm i ne i f a can d i d ate prod u ct m ay be ad opted i n to th e
q u al i fi ed E O prod u ct fam il y an d EO processi n g categ ory sh al l be d ocu m en ted . At a m i ni m u m , thi s d ocu m en tati on
sh ou l d i n cl u d e th e fol l owi n g :
a) Th e com pl ete speci ficati on for th e can d i d ate prod u ct, wh i ch fu l l y d escri bes th e prod u ct con fi g u rati on an d h ow i t
i s to be presen ted to th e EO process (packag i ng an d l oad con fi g u rati on ). Th e speci fi cati on sh ou l d al so i ncl u d e or
reference th e req u i red Steri l i ty Assu ran ce Level (SAL).
b) Th e resu l t of th e com pari son between th e can d i d ate prod u ct an d th e exi sti n g val i d ated prod u cts. Th i s resu l t
sh ou l d cl earl y d em on strate that prod u ct com pl exi ty, m ateri al s, packag i n g , an d l oad con fi g u rati on were assessed .
Th e d ocu m entation sh ou l d al so i ncl u d e an assessm en t th at the d ata revi ew provi d es assu ran ce that th e
can d i d ate prod u ct fu n cti on al i ty i s not comprom i sed by ad opti n g i t i n to th e process.
c) Evi d en ce or assessm en t of the bi obu rd en of th e can d i d ate prod u ct, th e rel ati ve resi stan ce of th e bi obu rd en to th e
i PCD, or both .
d) An assessm en t of EO resi d u al l evel s i n th e can d i d ate prod u ct.
e) Th e con cl u si on th at th e can d i d ate prod u ct i s su i tabl e for ad opti on i n to th e EO prod u ct fam i l y or EO processi ng
categ ory speci fi cal l y referenced in th e cu rren t val i d ati on stu d y to ach i eve th e speci fi ed SAL. Th i s con cl u si on
sh ou l d i ncl u d e or referen ce any ad d i ti on al test resu l ts perform ed to su ppl em en t th e exi sti n g val i d ati on stu d y an d
an y fu rth er testi ng perform ed for con firm ati on or q u al i fi cati on for rou ti n e rel ease of prod u ct from th e exi sti ng
val i d ated cycl e (resid u al testi ng , fu nction al testi n g , etc. ).
f) Approval by the steri l i zati on speci al i st an d oth er i nd i vi d u al s as req u i red by th e ch ang e con trol practices wi th i n th e
org an i zati on, and assu ran ce th at th e d ocu m en tati on i s retain ed an d retri evabl e.
4 Process equivalence
4.1 General
Process eq u i val en ce i s a m eth od u sed to d em on strate th at th e sam e val i d ated steril i zation process i s d el i vered by
two or m ore pi eces or sets of eq u i pm en t. I t d oes n ot req u i re th at the eq u i pm en t be ph ysical l y i d en tical . Even if the
param eters d el i vered by th e eq u i pm en t are n ot statistical l y i d en tical , th e processes d el i vered m ay sti l l be con si d ered
eq u i val en t i f they are al l capabl e of ru n ni n g th e process wi th in th e d efi n ed , val i d ated process l im i ts.
Process eq u i val en ce am on g m u l ti pl e pi eces of eq u i pm en t is i n ten d ed to m in im i ze th e am ou n t of testi n g req u i red to

q u al i fy th e process. Th e steri l i zati on process sh ou l d be val i d ated i n on e ch am ber. Th e rem ain i ng eq u i pm en t m ay
u n d ergo red u ced PQ i f i t h as u n d erg on e i n stal l ati on q u al i fi cati on (I Q) an d operation al q u al i fication (OQ) (see 1 2. 5. 1 ,
an d D. 1 2. 5. 1 of AN SI /AAMI /I SO 1 1 1 35: 201 4). Eq u i val en ce m ay al so be u sed to red u ce req u al i fi cati on of several
pi eces of eq u i pm ent. Th e eq u i pm en t u sed to d el i ver a steri l izati on process com m on l y consi sts of a cham ber or room
an d anci l l ary con trol system s. Steri l i zati on process eq u i pm en t can be l ocated wi th i n a g i ven processi ng faci l i ty or
am on g several faci l i ti es. Th i s eq u i pm en t can be u sed i n d epen d en tl y to d el i ver th e same process con d i tion s an d can
be exactl y th e sam e d esig n or can d i ffer i n si ze or i n th e exten t of an ci l l ary eq u i pmen t.
Process eq u i val en ce can be establ ish ed th rou g h an al ysis of process d ata i n com bi n ation wi th a m icrobiol og i cal
eval u ation . Th e process d ata sh ou l d d em on strate th at the can d i d ate eq u ipm en t is perform i n g wi th in an acceptabl e
ran g e of con trol (i . e. , val id ated process param eters can be con si sten tl y d el i vered to the prod u ct). Th e d ata an al ysi s
sh ou l d con fi rm th at th e process consistentl y operates wi th i n th e d efi n ed tol eran ces for th e val i d ated param eters. Th e
m i crobi ol ogi cal eval u ati on wi l l d em on strate th at th e req u i red SAL i s ach i eved .
4.2 Requirements of process equivalence
Process eq u i val en ce can be establ ish ed reg ard l ess of wh eth er th e eq u i pm en t is l ocated i n the sam e faci l i ty or in
d i fferen t facil i ti es. Th e req u i rem en ts to be m et pri or to th e establ ish m en t of a process eq u i val en ce prog ram are:
a) fu l l val i d ation of th e steri l i zati on process i n at l east one exi sti n g system (steri l i zati on ch am ber, aerati on an d
precon d i ti on i n g areas/ch am bers i f appl i cabl e, an ci l l ary eq u ipm ent, m on i tori ng i nstru m en ts, an d con trol system )
accord i n g to th e req u i remen ts of AN SI /AAMI /I SO 1 1 1 35: 201 4;
b) perform an ce of th e I Q an d OQ stu d i es d em on strati n g an d d ocu m en ti ng th at al l eq u i pm en t h as been i n stal l ed i n

accord ance wi th en g in eeri n g specifi cati on req u i rem en ts an d operates i n accord an ce wi th those req u i rem en ts;
c) d efi ni ti on of th e process to i n cl u d e th e tol eran ces al l owed an d d ocu m en tati on of al l ph ases of th e process; an d
d) process d ata an al ysi s associated wi th th e val i d ated tol eran ces for th e can d i d ate eq u i pm en t an d th e ori g i nal
eq u i pm en t (see 4. 3. 1 ).
4.3 Determination of process equivalence
Th e eq u i val en ce of th e steri l i zati on process d el i vered by one pi ece of eq u i pm en t to th at d el i vered by an oth er piece of
eq u i pm en t can be establ ish ed by com pari n g th e d ata obtai n ed wh en ru n n i n g th e sam e val i d ated process in each
pi ece of eq u ipm en t. Th i s com parison shou l d i ncl u d e an eval u ation of th e eq u i pm en t’ s capabil i ty to reprod u cibl y
d el i ver th e d esi red process param eters wh en ru n n i n g a n orm al prod u cti on l oad . Data obtai n ed d u ri n g th e PQ on the
process can al so be u sed . Th e d el i vered param eters an d tol eran ces sh ou l d be th ose th at were previ ou sl y val i d ated i n
th e PQ of th e steril i zation process i n th e ori g in al eq u i pm en t.
Th e eval u ati on of eq u i val en ce i n vol ves perform i n g a process an al ysi s an d eval u ati on as wel l as a m i crobi ol og ical
eval u ati on .
4.3.1 Process analysis and evaluation
An an al ysi s of process d ata associ ated wi th a val i d ated process in th e can d id ate eq u i pm en t an d th e ori g in al
eq u i pm en t is perform ed . Process d ata sh ou l d be col l ected from th e can d i d ate eq u i pm en t. Th ese d ata sh ou l d be
com pared wi th th e param eter l i m i ts for th at specifi c steri l i zati on process and th e resu l ts obtain ed i n th e PQ of th e
ori g i n al eq u ipm en t. Th e param eter l i m i ts are th ose establ ish ed i n th e i n i tial val i d ati on for th e steri l i zati on process
(i n cl u d in g al l process req u i rem en ts id en ti fi ed in AN SI /AAMI /I SO 1 1 1 35: 201 4) in th e exi sti n g eq u i pm en t. Th e
speci fi cati on s, acceptan ce cri teri a, an d pal l et or l oad con fi gu rati on sh ou l d be th e same as th ose d efi n ed for th e i n i tial
PQ. Th e actu al param eters to be eval u ated i n th e eq u i val en ce d eterm in ation are g en eral l y a su bset of th e en ti re
process speci fi cati on. Th e param eters sel ected an d the ration al e for th ei r sel ecti on sh ou l d be d ocu m en ted . Statistical
m ethod s th at eval u ate both the cen tral ten d en ci es of th e test d ata an d th e d eg ree of vari abil i ty of th e d ata can be
u sed i n th i s eval u ati on . Exam pl es of statistical an al ysi s approaches are presen ted in AAMI TI R1 5. Th e exam pl es are
i l l u strati ve onl y, an d are in ten d ed to provi d e gu i d an ce on stati stical cal cu l ati ons, n orm al ity req u i rem en ts, an d steps to
take i f th e d ata fai l a n orm al i ty test.
I f th e process an al ysi s an d eval u ati on d o n ot m eet th e establ ish ed acceptan ce cri teria, th en i t i s n ot possi bl e to
d em on strate process eq u i val en ce.
4.3.1 .1 Evaluation of preconditioning or aeration areas
Th e req u i remen ts for establ i sh i n g process eq u i val en ce are th e sam e for precond i tion i n g or aeration areas, wi th th e
excepti on th at hu m i d i ty u su al l y d oes n ot appl y to aeration .
An eval u ati on th at com pares th e l oad tem peratu re an d h u m id i ty profi l es wi th i n each en vi ron m en t shou l d be
perform ed . At a m i n i m u m , tem peratu re an d h u m i d i ty u ni form i ty wi th i n th e l oad an d th e rel ation sh i p of th is u n i form i ty
wi th th e correspon d i n g set poin ts an d record ed con trol vari abl es for the areas sh ou l d be eval u ated . I f th e pi eces of
eq u i pm en t u se d i fferen t set poi n ts or h ave d i fferen t con trol l i m i ts, i t m ay n ot be possi bl e to d ecl are th at th ey are
eq u i val en t.
Process eq u i val ence for th e precon d i tion in g or aerati on processes can be establ ished i f anal ysi s of perform an ce d ata
con cl u d es th at con d iti on s wi th i n th e l oad m eet th e param eter l i mi ts (e. g . , tem peratu re d i stri bu ti on , resi d u al l evel s,
etc. ) at th e en d of precon d i tioni n g or th e en d of aerati on . Prod u ct EO steri l i zati on resi d u al l evel s sh ou l d be veri fi ed for
a represen tati ve or m aster prod u ct i n the can d i d ate aerati on room /ch am ber/cel l to con firm th e eq u i val en ce of th e
prod u ct rel ease ti m e.
4.3.1 .2 Evaluation of sterilization chamber performance
An eval u ati on th at com pares th e d el i very of process param eters for th e l oad i n th e can d id ate eq u i pm en t to th e d ata
obtai n ed i n th e PQ of the exi stin g val i d ated eq u i pm en t or i n prod u cti on ru ns sh ou l d be perform ed . Th e cri ti cal process
an d l oad param eters to be com pared sh ou l d be d efin ed for th e steri l i zati on process before th e eval u ati on is
perform ed . Th ese param eters are u n i q u e for each steri l i zati on process bu t m ay i n cl u d e th e fol l owi n g :
a) Load param eters
1) Prod u ct tem peratu res—Tem peratu res ach i eved an d th ei r d i stri bu ti on wi th i n the l oad throu g h ou t th e
cycl e. See AN SI /AAM I /I SO 1 1 1 35: 201 4 for a recom m en d ati on of th e n u m ber of sen sors th at can be
u sed .
2) Prod u ct h u m i d i ty—H u m i d i ty ach i eved an d i ts d istri bu ti on wi th i n the l oad at th e en d of con d i ti on i ng . See

AN SI /AAMI /I SO 1 1 1 35: 201 4 for a recom m en d ati on of th e n u m ber of sen sors th at can be u sed .
b) Process param eters
1) Ch am ber h u m i d i ty at sel ected ti m es d u ri n g th e cycl e (e. g . , en d of con d i ti on i n g or start of g as d wel l ).

Th i s param eter may be m easu red d i rectl y or m ay be based on pressu re rise d u e to steam i n j ecti on.
2) Ch am ber tem peratu re at sel ected ti m es d u ri n g th e cycl e (e. g . , en d of con d i ti on i ng or start of g as d wel l ).
3) Ch am ber EO concen trati on at sel ected tim es d u ri n g g as d wel l d u ri n g th e cycl e (i f m easu red ), or g as
pressu re ri se or g as wei g ht.
Oth er process param eters that m i g h t be con si d ered i n cl u d e:
i.) vacu u m d epth an d rate at sel ected ti m es d u ri n g th e cycl e;
ii.) h u m i d i fi cati on tim e an d steam i n j ection rate;
iii.) g as i n j ection tem peratu re an d ti m e an d th e am ou n t of g as u sed (wei g h t, concen trati on , or pressu re); an d
i v. ) ai r or n i trog en i n jecti on rate.
An an al ysi s of the process d ata i s u sed to i n d i cate th at th e processes are or are n ot eq u i val en t i n th eir abi l i ty to m eet
th e exi sti n g process param eter l i m i ts an d an y ad d iti on al acceptance cri teria. Th e d ata g en erated sh ou l d be an al yzed
an d com pi l ed in a form at th at wi l l al l ow for i ts u se i n fu tu re process eq u i val en ce d eterm i n ation s.
4.3.2 Microbiological evaluation
I n th e m icrobi ol og ical eval u ation , a fracti on al or hal f cycl e i s perform ed to d em onstrate that th e steri l i zati on process i s
capabl e of d el i veri n g th e d efi ned m i n im u m SAL i n al l the eval u ated pieces or sets of eq u i pm en t.
N OTE —I f th e ru n used d u ri n g process an al ysi s was a fracti on al or h al f cycl e an d i n cl u d ed m icrobi ol og i cal m on i tori n g, th en th e d ata
m ay al so be used for th is eval u ation .
I n ad d i tion to th e d el i very of a m i ni m u m SAL, ad d iti onal factors th at sh ou l d be eval u ated in cl u d e an y ch an g es to th e

steril i zation l ocati on or m an u factu ri n g l ocati on th at can h ave an i m pact on th e bi obu rd en l evel of th e prod u ct as
presen ted for steri l i zati on . I n creased d i stan ces between th e m an u factu ri n g faci l i ty an d steri l i zation si te can resu l t in
h i g h er bi obu rd en l evel s, especi al l y if th e prod u ct wi l l su pport m i crobi al g rowth . Di fferen ces in m an u factu ri n g
en vi ronm en ts can l ead to th e m an u factu re of prod u ct wi th hi g h er or m ore resistan t bi obu rd en l evel s th an previ ou sl y
q u al i fi ed , even i f th e prod u ct d oes not su pport m i crobi ol og ical g rowth . An oth er issu e to be eval u ated wh en sh ippin g
prod u ct between si tes is the d i fferen ce in sh i ppi n g cond i ti on s, su ch as ti m e in tran si t an d season al effects
(tem peratu re, h u m i d i ty, etc). Th e n eed to h ol d prod u ct u n d er d efi n ed con d iti on s to sim u l ate sh i ppi n g /tran sport
con d i ti on s sh ou l d be i n cl u d ed in th e eval u ati on of an al ternate steri l i zati on l ocation or m an u factu ri n g l ocation .
4.3.3 Results evaluation

Th e resu l ts of th e eval u ati on wi l l d eterm i n e wh eth er th e d i fferen t pi eces or sets of eq u i pm en t perform eq u i val en tl y. I f
th e d i fferen t pi eces or sets of eq u i pm en t are eq u i val en t, th en th e req u i rem en t for a red u ced m i crobi ol og ical PQ h as
been sati sfi ed th rou g h th e testi n g th at was al read y perform ed an d n o fu rth er q u al i fication wou l d be req u i red . I f th e
con cl u si on of ei th er th e process an al ysi s an d eval u ation or th e m i crobi ol og i cal eval u ati on i s th at th e processes are
n ot eq u i val ent, th en th e process sh ou l d be d ecl ared “n ot eq u i val en t” an d a PQ sh ou l d be perform ed accord i n g to the
req u i rem en ts of AN SI /AAMI /I SO 1 1 1 35: 201 4.
4.4 Process requalification and maintenance of equivalence

Referen ce req u i rem en ts i n AN SI /AAMI /I SO 1 1 1 35: 201 4 secti on 1 2. 3 an d g u i d an ce i n An n ex D. 1 2. 3.
Req u al i ficati on sh ou l d in cl u d e an assessm en t of an y ch an g es mad e to th e process, th e eq u i pm en t, or th e prod u ct

l oad bei n g steri l i zed . If th is an al ysi s i n d i cates th at si gn i fi can t ch an g es h ave occu rred , th e param eters an d
req u i rem en ts of th e eq u i val en ce d eterm i n ati on sh ou l d be reeval u ated and , i f n ecessary, m od i fied . I n ad d i ti on , a
revi ew of an y process n oncon form an ces sh ou l d be perform ed d u ri n g th e revi ew peri od for each pi ece of eq u i pm en t
to d eterm i n e wh eth er th e d el i very of th e process has been com prom i sed i n som e way.
To g u ard ag ai nst u n reported or i n ad verten t ch an g es, on e sh ou l d al so con sid er period ic repeti tion of a part of th e
perform an ce q u al i ficati on . Th e i n terval between peri od i c req u al i ficati on s sh ou l d be d eterm i n ed by th e n atu re of th e
steril i zation process an d by the am ou n t of process d ata d ocu m ented . Th e i n terval m ay be vari ed , taki n g i n to accou n t
h i stori cal d ata th at d em on strate process reprod u ci bil i ty an d con form an ce wi th establ i sh ed speci fi cati on s for process
param eters. Th e d ecisi on to perform req u al i fi cati on m ay be even t rel ated or tim e rel ated an d sh ou l d be d ocu m en ted .
AN SI /AAMI /I SO 1 1 1 35: 201 4 req u i res th at th e steri l i zati on process be req u al i fi ed on a peri od i c basis. A d efi n ed
process eq u i val en ce prog ram can be u sed to m eet thi s req u i rem en t. I f an y eq u i val en t pi ece of eq u i pm ent fai l s th e
peri od i c eq u i val en ce revi ew, th en it shal l be rem oved from th e eq u i val en ce l i st an d be req u al i fi ed on i ts own .
Mai n ten an ce of eq u i val ence wou l d al so i ncl u d e a revi ew of ch an g es to each piece of eq u i pm en t, th e m anu factu ri n g
process, th e prod u ct l oad , and th e steri l i zati on process to en su re th at these ch an g es d o n ot com prom ise th e overal l
d eterm i n ati on of eq u i val en ce. Th i s revi ew sh ou l d be con d u cted an d d ocu m en ted before ch an g es are m ad e an d
sh ou l d be part of th e ch an g e con trol process.
4.5 Documentation
Al l d ecisi on s rel ated to th e ou tcom e of th e an al ysi s d eterm i n i n g wh eth er can d i d ate eq u i pmen t m ay be d ecl ared
eq u i val en t to th e exi sti n g steri l i zati on process eq u i pm en t sh al l be d ocu m en ted . At a m ini m u m , th i s d ocu m en tati on
packag e shou l d i n cl u d e:
a) Th e com pl ete specifi cati on for th e can d i d ate eq u i pmen t, wh i ch fu l l y d escribes the eq u i pm en t, operati ng
speci ficati ons, an d tol eran ces, an d wh i ch refers to or provi d es a l ist of appl i cabl e operati n g proced u res,
cal i brati on proced u res, an d m ai n ten ance sch ed u l es. Th is speci fi cati on sh ou l d i n cl u d e or referen ce the cu rren t I Q
per AN SI /AAMI /I SO 1 1 1 35: 201 4.
b) Evi d en ce or assessm en t of th e abil i ty of th e eq u i pm en t to d el i ver the i n ten d ed process. Th e evi d ence or

assessm en t sh ou l d i n cl u d e or referen ce th e cu rren t OQ per AN SI /AAM I /I SO 1 1 1 35: 201 4.
c) Th e resu l t of th e com pari son between th e can d i d ate process eq u i pm ent an d th e exi sti n g val i d ated process
eq u i pm en t. Th i s com pari son sh ou l d cl earl y d em onstrate that al l maj or system s an d critical param eters were
assessed , i ncl u d i n g stati sti cal an al ysi s (i f u sed ).
d) Evi d en ce or assessm en t of th e prod u ct con d i ti ons d u rin g processi ng wi th i n th e can d i d ate eq u i pm en t to

d em on strate eq u i val ence to the exi sti n g process.
e) Resu l ts of th e eval u ati on of an y ad d i tion al factors th at cou l d affect th e l eth al ity of th e steri l i zati on process, as
appropri ate.
f) Th e d ocu m en ted con cl u si on th at th e can d i d ate eq u i pm en t is eq u i val en t to th e eq u i pm en t speci fical l y referen ced
i n th e cu rrent val i d ati on stu d y to achi eve th e speci fied SAL. Th i s con cl u si on sh ou l d i n cl u d e or reference an y
ad d i ti on al tests perform ed to su ppl em en t th e exi sti n g val id ati on stu d y an d an y fu rther testi ng perform ed for
con fi rm ati on or q u al i fi cati on for rou ti n e rel ease of prod u ct from th e exi sti ng val i d ated cycl e (e. g . , resi d u al testi n g,
fu n cti on al testi n g on first th ree l ots, etc. ).
g) Approval by th e steri l i zati on special ist and oth er in d i vi d u al s as req u i red by th e n orm al ch an g e con trol or process
d ocu m entation con trol practi ces wi th i n th e org an i zati on .
h) A l i st of appl i cabl e steril i zer operati n g proced u res an d speci fi cati on s issu ed or ch an g ed to au th ori ze u se of the
can d i d ate eq u i pm ent for rou ti ne processi n g of prod u ct.
Annex A
Guide for evaluation of a product for adoption into an EO product
family or EO processing category
A.1 General
Th i s g u i d e is n ot an al l -in cl u si ve l i st. I f th e an swer to an y of th e fol l owi n g q u estion s i s “yes, ” fu rth er eval u ation to
i n cl u d e prod u ct q u al i fi cati on stu d i es of th e cand i d ate prod u ct m i g h t be req u i red to d eterm in e i f th e can d i d ate prod u ct
i s m ore d i ffi cu l t to steri l i ze th an th e exi sti n g val i d ated prod u ct or PCD (see 3. 4).
A.2 Design characteristics

I n rel ati on to th e exi sti n g val i d ated prod u ct, d oes th e can d i d ate prod u ct h ave
1) m ore restri cted passag eways or i n n er ch am bers;
2) fewer open i n g s;
3) m ore i n tern al su rfaces;
4) m ore m ated su rfaces; or
5) m ore cl osu res?
A.3 Materials and other characteristics

I n rel ati on to th e exi sti n g val i d ated prod u ct, d oes the can d id ate prod u ct h ave
1) m ateri al or ch aracteri sti c ch an g es or d i fferen ces that m ay red u ce th e tran sfer of h eat, m oistu re, or
steril an t g as;
2) m ateri al s th at are kn own to retai n h i g h er EO resi d u al l evel s;
3) m ateri al s that wou l d be d am ag ed by E O;
4) m ore m ateri al s from bi ol og ical sou rces;
5) tem peratu re, pressu re, or m oi stu re l im i tati on s th at th e exi stin g EO process can not m eet;
6) a si g n i fi can tl y d i fferen t bi obu rd en wi th reg ard to types, n u m bers, an d resistan ce;
7) a m an u factu ri n g or assem bl y process th at occu rs i n a l ess con trol l ed en vi ronm en t;
8) l ess i n -process cl ean i ng ; or
9) m ore h an d l i ng d u ri n g th e m anu factu ri n g process?
A.4 Sterile barrier system

I n rel ati on to th e exi sti n g val i d ated prod u ct:
1) Does an ythi n g su ch as th e prod u ct, prod u ct wrap, or im perm eabl e sh eets cau se ven ts to be m ore
occl u d ed ?
2) I s an y wrap d i fferen t in type, n u m ber of l ayers, basi s wei g h t, coati n g , or treatm en t from th e exi sti n g
wrap?
3) I s there a d i fference i n the type of ven ti n g m ateri al (e. g . , paper i nstead of n on woven pol yol efi n )?
4) I s there a d ecrease i n th e porosi ty of th e ven ti n g m ateri al (e. g . , basi s wei g h t, coati n g , treatm en t, or
appl i cati on of secon d ary l abel s)?
10 © 201 7 Associati on for th e Ad van cem en t of M ed i cal I n stru m en tati on  AAMI TI R28: 201 6
5) I s th ere a d ecrease in the su rface area of the ven ti n g m ateri al or u n d erl yi n g openi n g?
6) Does th e packag i n g m ateri al in crease th e bi obu rd en l evel of th e prod u ct?
7) H as a secon d (d ou bl e) steri l e barri er system been ad d ed ?
8) Does th e packag e d esig n , m ateri al s, or prod u ct pl acem ent m ake it h ard er to h eat the prod u ct or
restri ct gas fl ow i n th e prod u ct?
9) Does th e steril i zati on process d am ag e or cau se d eg rad ati on of th e packag i ng m aterial s or seal s?
1 0) Does the arran g em en t of i n d ivi d u al packag es in th e protecti ve packag i n g cau se ven ts to be m ore
occl u d ed by n on ven ted su rfaces of other prod u cts i n th e protecti ve packag i n g or by th e protecti ve
packag in g i tsel f?
A.5 Load characteristics

I n rel ati on to th e exi sti n g val i d ated prod u ct:
1) H as th ere been an ad d i ti on or ch ang e i n case pol yl i ner(s), or an i n crease in th e n u m ber of in n er shel f

packs?
2) H ave ad d i ti onal l ayers of protecti ve packag i n g been ad d ed ?
3) I s th e stretch or sh ri n k wrap u sed to h ol d pal l et l oad s d u rin g processi n g of a g reater th i ckn ess or
d en si ty?
4) H as th ere been a ch an g e in th e com posi ti on, d en si ty, or th i ckn ess of th e protecti ve packag i ng
m ateri al s?
5) H ave th ere been an y ad d iti on s or ch an ges i n the protecti ve packag i n g m ateri al s th at m i gh t m ake i t
h ard er to h eat th e prod u ct or to red u ce th e fl ow or d i ffu si on of EO, m oi stu re, an d ai r or th at m i g h t
affect E O resi d u al s?
6) H as the pl acem en t or th e con fi g u rati on of the “I nstru ction s for U se” bookl et affected th e packag i n g
system ?
7) H as th ere been a ch ang e i n th e d en si ty of th e overal l pal l et or l oad th at pl aces th e can d i d ate prod u ct
ou tsi d e th e val i d ated d en si ty ran g e?
8) I s the pal l et con fi g u rati on m ore d en se, or are th ere fewer exposed box su rfaces?
9) H as the u se of chi m n eys or oth er ai r spaces in the pal l et been red u ced ?
1 0) H as the overal l l oad in g of th e ch am ber i n creased or d ecreased ?
11) H ave th ere been ch an g es i n con fi gu ration that red u ce h eat tran sfer or g as fl ow th at cou l d affect EO
resi d u al s of th e prod u ct?
Bibliography
[1 ] Associ ati on for th e Ad van cem en t of Med i cal I n stru m en tati on . Biological evaluation of medical devices—Part
7: Ethylene oxide sterilization residuals . AN SI /AAMI /I SO 1 0993-7: 2008. Arl i ng ton (VA): AAM I , 2008.
[2] Associ ati on for th e Ad van cem en t of Med i cal I nstru m en tati on . Contract sterilization using ethylene oxide.
AAMI TI R1 4: 2009. Arl i n g ton (VA): AAMI , 2009.
[3] Associ ati on for th e Ad van cem en t of Med i cal I n stru m en tati on . Ethylene oxide sterilization equipment,
process considerations, and pertinent calculations . AAMI TI R1 5. Arl i n g ton (VA): AAM I .
[4] Associ ati on for th e Ad van cem en t of Med i cal I nstru m en tati on . Process development and performance
qualification for ethylene oxide sterilization—Microbiological aspects. AAMI TI R1 6. Arl i n g ton (VA): AAMI .
[5] Associ ati on for the Ad vancem en t of Med i cal I nstru m en tation . Sterilization of health care products—Ethylene
oxide—Requirements for development, validation, and routine control of a sterilization process for medical
devices. AN SI /AAMI /I SO 1 1 1 35: 201 4. Arl i n g ton (VA): AAMI , 201 5.
[6] Associ ati on for the Ad van cem en t of Med i cal I nstru m en tati on. Sterilization of health care products—
Microbiological methods—Part 2: Tests of sterility performed in the definition, validation, and maintenance of
a sterilization process for medical devices. AN SI /AAM I /I SO 1 1 737-2. Arl i n g ton (VA): AAMI .
[7] Associ ati on for the Ad van cem en t of Med i cal I nstru m en tati on. Sterilization of health care products—
Vocabulary. AN SI /AAM I /I SO TI R1 1 1 39: 2006. Arl i n g ton (VA): AAM I , 2006.
[8] Associ ati on for the Ad van cem en t of Med i cal I n stru m en tati on . Sterilization of medical devices—
Microbiological methods—Part 1: Determination of a population of microorganisms on products .
AN SI /AAM I /I SO 1 1 737-1 : 2006. Arl i n g ton (VA): AAMI , 2006.
12 © 201 7 Associati on for th e Ad van cem en t of M ed i cal I n stru m en tati on  AAMI TI R28: 201 6

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Technical

Product adoption and process equivalence for

Approved 1 8 N ovem ber 201 6 by

Al l stan d ard s, recom m en d ed

© 201 7 by th e Associ ati on for th e Ad van cem en t of M ed i cal I n stru m en tati on

Pri n ted i n th e U ni ted States of Am erica

ISBN 978-1 -57020-654-2

Glossary of equivalent standards ......................................... ................................................... ...................................... iv

Cochairs: J on ath an Bu l l , J oh nson & J oh n son

Members: Erin Armstron g, B Braun Medical

Alternates: Au g u st Bau r, Cen tu ri on Steri l i zati on Servi ces

Th e process eq u i val ence secti on of th i s TI R wi l l provi d e g u i d an ce on h ow to establ i sh eq u i val en ce between

Product adoption and process equivalence for

a) a n ew prod u ct is bei n g ad d ed to th e previ ou sl y val id ated process,

b) ch ang es to val i d ated prod u cts are bei n g eval u ated ,

d) eq u i val en cy of a steri l i zati on process i s bei ng eval u ated .

2 Terms and definitions

3.1 Establishment of an EO product family

c) m an u factu ri n g en vi ron m en t or area,

d) m ateri al of con stru cti on ,

f) steri l e barri er or protecti ve packag in g con fi g u rati on ,

h) si ze and /or su rface area, and

3.3 Evaluation for product adoption

3.3.1 Determination of adverse effects

3.3.2 Determination of product design effects

3.3.3 Determination of product material and characteristics effects

3.3.4 Determination of sterile barrier system effects

3.3.5 Determination of load configuration effects

3.4 Conclusions of product adoption evaluation

3.4.1 Comparative resistance study

b) at l east a m i crobi ol og ical PQ wou l d be req u i red .

3.4.2 Temperature and humidity distribution study

b) at l east a m i crobi ol og ical PQ wou l d be req u i red .

3.4.3 Residual study

3.5 Maintenance of EO product adoption

d) An assessm en t of EO resi d u al l evel s i n th e can d i d ate prod u ct.

Process eq u i val en ce am on g m u l ti pl e pi eces of eq u i pm en t is i n ten d ed to m in im i ze th e am ou n t of testi n g req u i red to

4.2 Requirements of process equivalence

b) perform an ce of th e I Q an d OQ stu d i es d em on strati n g an d d ocu m en ti ng th at al l eq u i pm en t h as been i n stal l ed i n

4.3 Determination of process equivalence

4.3.1 Process analysis and evaluation

4.3.1 .1 Evaluation of preconditioning or aeration areas

4.3.1 .2 Evaluation of sterilization chamber performance

a) Load param eters

2) Prod u ct h u m i d i ty—H u m i d i ty ach i eved an d i ts d istri bu ti on wi th i n the l oad at th e en d of con d i ti on i ng . See

b) Process param eters

1) Ch am ber h u m i d i ty at sel ected ti m es d u ri n g th e cycl e (e. g . , en d of con d i ti on i n g or start of g as d wel l ).

Oth er process param eters that m i g h t be con si d ered i n cl u d e:

i.) vacu u m d epth an d rate at sel ected ti m es d u ri n g th e cycl e;

ii.) h u m i d i fi cati on tim e an d steam i n j ection rate;

i v. ) ai r or n i trog en i n jecti on rate.

I n ad d i tion to th e d el i very of a m i ni m u m SAL, ad d iti onal factors th at sh ou l d be eval u ated in cl u d e an y ch an g es to th e

4.3.3 Results evaluation

4.4 Process requalification and maintenance of equivalence

Req u al i ficati on sh ou l d in cl u d e an assessm en t of an y ch an g es mad e to th e process, th e eq u i pm en t, or th e prod u ct

b) Evi d en ce or assessm en t of th e abil i ty of th e eq u i pm en t to d el i ver the i n ten d ed process. Th e evi d ence or

d) Evi d en ce or assessm en t of th e prod u ct con d i ti ons d u rin g processi ng wi th i n th e can d i d ate eq u i pm en t to

A.2 Design characteristics