ÏÏTLE "Development of the nr crnbio] opioal oortrol aspects of radiation sterilization of medical supplies, (part of a coordinated programme on radiation steri]i^atior of medical and 'bi^lopical products) ?ÏHiL KEPOKT FOR THE PEFIQD ; ''A" 1976-01-01 - 1078-0 3-^! AUTJCF(s) Textile Pepearch Institute >"'""IC EKEKCT AGËMGY v-
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ÏÏTLE
"Development of the nr crnbio] opioal oortrol aspects ofradiation s ter i l izat ion of medical supplies, (part ofa coordinated programme on radiation s ter i ] i^a t ior ofmedical and 'bi^lopical products)
?ÏHiL KEPOKT FOR THE PEFIQD
;''A"
1976-01-01 - 1078-0 3-^!
AUTJCF(s)
Textile Pepearch Institute
>"'""IC EKEKCT AGËMGY
v-
F I N A L R E P O R T
Agency Research Contract No. 1689 / R / RB
Development of the microbiological control aspects of radiation
s ter i l iza t ion of medical products
State Textile Research Ins t i tu te Libérée
664 71 Veverskà BittfâkaCzechoslovakia
Chief scientific investigator: V. CH&KOVit - HOR/KOViCo-authors: P. fiERNtf
D. OLBRICHOVi
Période of investigations: January - "December 1976April 1977 - March 1976
Vorka donc undtr tha Baasaxcn Contract No* 1689/fij/BB nay*ba«n aiaad at following prograai- •valuation of variability in pr«-starili»ation aioreblal
oontanlnatlon of aadical auppliaa rvprtaanitd ly hydropîiillcgaus* swabs and dtMO-apidfcrsuû ipaftêf : - '
- «tap» to oorralat* tat laval of initial «oant* ly usingaub-procasa radiation doa«a and the radiation doaa raquiradfor achiaving aoctptabla laval of pracUcal at«rilitart and
• aiorablological atudita to r«golat« to* production bygianaand the aliJdnation of pathogtnaa from tba «adical
tionEvaluating of th« Influwua of aub-^roctu»6f ganta-radiatioa on dcoontanlnatlon ôfphlllc g a w B abs ••*••»•••••*•••••••••••••••B*t«Talnatioo of ioactlvattoo e w m ••••••••»•Bloch«Bdcal typl»aUon of iaoUttd ata-aln» ••••Statistical • • • • • • • • • • • • • • • • • • • • • • « • • • • •
Fra-atarilisation contamination of-gauaa swabs .....••a*»«..«'*.*...«Suab-atariUBation doaa» and tba dacraasa in -:
noabar of «ontaainataâ products •••••••• . . ••••;;^i«atl«;6f;-'i»i!«r««pgioli»s-: aurriTing tha ir - :radUtlon by aub-atarill»ation doaas ••••••••••Baalttsnea of atraina iaolatad fro» hydropbiUogaust avabs lrradiatad by i î and 9 kd/kg . . . • • •
% "•»••».*•*•.»•••••••••••••••••••.•••*
fapam publiabad OD work dooa uodar *ha ContractCopy of tba pajoar * RadiostarilUatian of damo-•pidaii»al grafta " by •* Cft/lkoré-Horikoiré, X.«uriiakwri, F. Han in pr«aa in Raa. in
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•• - c ' \ • <:, - .. ,';, i ' • ; • . ; • j . .
'Jt' •*' »*l ' . i / ' / , V , ' ,'" ' -.. . f « .^-' [..'..
'• . Vv'
' '• '''' '• • ' ' • • < - • • • • ' - • ' * L
'~ - ~ - Ï • ' '- •
to th.
t pr••di««l •applioa udten**, to^prodéci^-;..1^^;<*n-b«;>tnll*
with th* «pplicaUwi of r*di»U»n ;>
*. .^-- : . . - ». . - - • ? ' 'VA. . .
.. .-ji^^i^
«hoio» of th« »ttriU««Uon d«M i» on» of th«A» U to» di»FO»«bl« ••dic. l «sçpU»»
fitnio ••ndlUo»» th« «p«ri«BC« of
tltod» ^ t» th«•ttltod» ^ t» • / th« «th« «* d ^
th» jr « ar ^ *V , • « • Wfhly •oat«^in«t«d «*t«rl«U fir«t #f »U »f
^#f
I à
of
t * « ^ ifc« IMrtii^ of «»• »d itt»t» «Urlllwittwa 4^«»
Daaplta tha eonaidtrabla Mount of aarlg afforta iatha aatabliahaant «T tha art topi» *o* alerobiolocUaX controlant». aafaty aapaat* i f radiation atarilisatiaa yraatiea» th*altaation ramaina aantfarajralal attd as yat n»t aatiafaetaxyaolrad. Xaa raqaixa* atawtar*» ^L such «rittrla aj «M Tarl«aana-tlattal vaalit health aatharlUaa «iffar «tfely /T««|V*»aao«a«n4aUaaa f«i»ol»tad daa to tha Uitlatiira «f UKA
k«k *at tetto^t a sitar aaa*»r.
I» aaaoaaUan idtH radlaUon atwiUaatlona aoabar of alarobiélafUal satnad» waa prapaaaA and
aatailjr im th» aaoraa of last tan yaara. Tollo»-appraaahaa ara Jlx^tly tr lnJlraatlj ralatad ta
• t w i l l V aa»t»l» T - -
af yagaa^aa thaaa hara te ««arantaa ta« «tariliiy« t i l l %tm atarillsa4 *\>at ia ua*4 / U / ,
aorax'aaa MA mÉâdjana <AM^#tosiiUsatlaK aoatttstW* 9 M Bat)M4 lial^f ta aataWiak th«
atartlltatlwi *— aaaar4iD« ta taa «aalraala atarllltr«9«ra« and glraa » r - « i***^*1 «N> Jtffltigr 1» protaatla»that «aà •« ao aoatwla* a«< ka»t ni a« apfva^rlata laral»
- Ta ara-laat* tha afflaiaaar af tfca ^tariUsaUa* «r«aaa«i t la »at aaffiaiamt J«at to htm a talatiTalj «&«• kaa«la4ca
aC tha »ra«atarili«attaa «ao^atuaUaa af pr^aata ta »aatariUta^ aiaaa ooathar baala qmaattaa ariaaa that l*aitatha atariUaaUaa praaaaa, X% ia tha 7aaiata»aa of thata«i mating «laraorgaala— ta « M atarlUsU* m*,***
caaia»a aaataalaatlf I tau prUr ta tha ataxiUaatta»
aft-araaaaa dofa» *• *>•••* •* «atl mating «faf araiuata tteaa rtaaia taataslaatad ty al
in,ta» thai* poaolatlatt af produit» aftar irradiai»Ian lay- liât» astbataattaBalls Invar thaa tb« prooaa* atariUs*atU» âcwtt* ' -ïha nfjfjaiift farfafiay at vaciaaa bact*»l«l atrais» ia»>-atad ttm aiMleal pvaâiMta, pra«wUaa awrirgiait and yatfladi«a«|2]r i«ralir«< i » Htm «anafaetwra was' takan oa » ba»aafar a*î«»lifhiB« to» attriliiatioa de«a by QtOOtweta «kdSIDUKaU/22/« *• «alaiOatt tka «ittlsM «aaa Xbê Initialodtmta af •iuraorfattiaas an ptftdoataf tba raaiatanoa atitfolaWt atr«U* aspr«saaâ ia IK10 raloM, and tha raajairad
«T «afatâr «ar« a#rtal4*ra«V ftquaatad areaadttra halpaU a t r t a ^ a* aal««tta« af «aaalUa «aalatamt «utaata,i a yroblaa iaWvaatlag f»r «aav aclaatitic «azkam
ta*t««% tatamlnUg tba imaetlrattam «vrras at atandattvaalaiaAt %* laitsiat raAfttla»* fba «atlxatlaft af
aurtia «•• raiaaaaadad am aaaaiaalaalac a» ra-wttaiia» plattta /U»28»«l/»
Rautt»a «amiral af HM atatilisimf pr#«ta» la inof ^ f^f |aa^ aan^tarf* i«a«
ft ai«m aaabar «f «alls af a atftftftard raalataat
' A •al«al»î» iafatmatla» aft tottraa af aUriUsatlon laay ^ t t i , ^ af dal4|yarata^y jtfttflftataé..awilaal agadyfta»kaaiatani miaraarfanUai» ara iaaattratad in tha asflsemmattttint ia eh«rMt«ristit for ta* *lTan kind af »x»d«at*j andaa tea âmai aat iaflaajwa «f •vrvmûimt aamdltlaM am 1*-araaaaaY dttrtaa* IK nanltJ¥l,% of adLaraaa» «an aa aattmaV•«/31,3a/.
^ b i ^ h «t rwxdo* mmt b* aonUaiMt /U,33/« *** M*»*criU«lMd, for w wr«ftli»tte^Jy hi^i nabnr «f•«q>lM t u t t o b t it«t«A in «rd«r to•igniflcwit rtvmtf /349 3V»
prebltm» «•«at«t*â «ithi l i«»i by 1«»1>U« T«Uati««* A écHûtlw* fo«l of
«t*HU«ftti«b pfeOfMMTlt to pro4tt«* stMil» «bjtcts and a»to* A»er««M «t «Iniaat himaanl of • fOMibl* iartetio» offiktlottte* In thi« r«a»«tt th« aiar«Bl«lQflc«l eontrolb«
3 t « d 1 • d
tut wtzfe» two »«*n «1M« «I 4»Ur«tn*tion «f tbt•fftdwwjr of tta* r»U«U«a «t«lll»»*ti»n K * t t w » «MU*°qt i—> r*dl«u«a «od «vftittftUta of * «Mitftbi» Mtbud tcontrol Xà» «ttri l i tj of dLtfOMoU ««dical
foU»«Ug qwtlaaa shall bo atadttd in odar to avalait» »o»»of abova disooaaad yrofelasat
- réot«tani}« of strnliM itolattd txvm yroduet»r»diat«4 by »^b-pro««sa doa««,
• «tiUrtoM» pt wxrtmtto
- p«aaiU« «rauiaUo* of atarlUly fro« ataUaUcal point ofVlOtt»
2» M • t h • d •
2 . 1 . Sfrukttod n*Wrl«l
fho works ho*t booa e«rrl«(i «at on aapplo* of kgrdxo»»turn* •**•• / 5 • 6 at / talk** roteloxOgr out of tho
prodaotlonal l i » o tgr *h» nuMMKf*etur«r for t^« p«xi«te «f « M
200 pl*e«e of*t to» «id of
mk» «in*SU»10
«roxy l w t
Ibe 9or«Hit«s>lU«atita touat» ofu m i i i l » iè# 0TW3T t i m t grfff'»sr 10 »aqpl««, «W.X* th»4tbtr groupe «•?• dtt«mla«d ÎN» «t^gr th« iAf luone* ofpcooo* 4p**« of
2«2«
th» y«lcroorganlas» th« s«Bplo* we»« rimiod for 30 «in in 300 a lof sSrauMn't b*ff«r /$h*t92/* ttw& MCOMAXT-, tho xi*»*»100 tU«« dllttttd «Ad forth** CLUltr«t«4 through a«mbr«o
• C*tch prodvtt srxiOR / 90 m «1*0» anroraco po^ro « 1 M<•»/• f l l t«f« wort iMtibatod 00 platoo with »lood ««or / 0 » i d
CM 55 wd 5 » of 4«fiorln*to4 «teop blood/ tê* 2 d«or» «t «of 25 *0 «ad«r MVOW« m& « M n t t i otmoijMo—*
ool fy aorphologr ond ooKVtntloool «loroooopgr of tr«M*•t«iaod ptropafttUoM woro aarlo»
•t-
•t«ltt»ttn« the rooalt»,,tbt «Mv»ptl»ft us» udo:tfeat «M «iartttil eolevjr mi «reatajt toy 4irl«ioa *f « M ««11.
2.3* of tfa» lnttaoneo «f
mte
I* »t«4y th» t«fi*iiMar iT dtff or*at 4OM* at p a|
1b* MMpl«« of gI P -
dot* If I , 5» T, • , 11» 1$ m i IS W/kC / 0,1 - 1,5 a n * A& *° . ID14
SÎMHM «qpuîatata nw* T«p««toê «irwjr «Mk «vtr «b*fM 7§«r a» will M III» f t i—t i— of
i «h» atàltif* oX tko Mtri|i«Ml M«1«>I MB »t*f»»N< .ill « 1 «*••!• 1, fl— b«Mli. «• oomtrol tlM tookaidtM t f ororlaylB<
ty tin» nutritional atdlua and » poaalbl» aeci&antal eontaainafe»Ion two additional «toril* tosVtuboa / without any gaus* avaaa /in arory groqp wor* f i l lod tgr tt» » * M JMdlai and eultlT«t«4under tia* mm» condition* M th» t«»V-tob«» i»ltt
14 âigr* of laetiba-tlwa 1b* fnmth oflan* wu obs*rr«A. fh« sarrlvinc strain* twmk Isolated o»plat»» «lth flat» Count agar /Oxol* CM J2i/ to ba idantlfladblocbMileallar and «ralttâttà £ro* «at poiat of radiation r«ai»V>aaca»
tit <i2*4»
rtalataxut* of baetcrlal strain laoSAtad fro» hydro-phtlia ipuair •»«*• aftar irradtatloA -»aa araltaatad ty .Aationaia»atlon of tnair inaotlYatlam «ttrvwa «aft ttal«ol«tln« tha laaattv»aUoft
«»ra aatlawtad for tao1
aovreaat
Jrradiaiar «rp» J-MOtt, «at* LW., aatlvlt» 4»fa • 30 .at Ifta b«eUBia« t f
atraiM Irara la«uaaU4 ait natrloataf«r/0Da»14 « V for 4« a aft* ayot^fonUc atralaa fa» f «aya** ta» a»Ua«l W«»«raV»a. i f tor laMbataaa a najgyaUn im0,0? M paaayaaf fcafft* wa» pr«F—* M i » 4 < n M ta •%arilt
^ ^ ^ T ^ ^ ^ ^ ^ ^ ^ ^ ^ J ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ * * ^ ^ T ^ W ^ w ^ p ' ? " T ^ ™ - t l | P ^ ' a r T V ^ ^ ^ P ^ W H ^ ( | ^ P T I ^ ^ I B ; ^ V ^ ^ ^ ^ V P ^ r i ^ ^ ^ ' - J I P ^ - ' '*- * " - , ' ' ^ ' " f i ' r i > t f ' *
of
i«oX«t*d ^ a f^ tgr «ub-
Or»«i«LD«d
«e
f««*nt«U«a of l prodacUo»,
r»l—»t ^aytlmt» Iwwly»!^ »r«èwtU«a »»l—»t ^aytlmt» Iwwly»!^ »r«èwtU«a »f j y » *fP—« «f »>iwyT>1 f t w t f<y—mUtlMff <!!>—••, «—alt
/ f^j lp:^:]^^
W /37/» 1«D» / W , » U » /31/ « ^ 1 » ^ ^ : "for T«a»«qr *f tU»tagrlM««el ««d «KroMMi740/
! K X > 7V^ /k-V tha typothaal* for Toiaaoadi»tributtoaia nmbar of •lereorganlp^a o» t«si>-p&«as» ofhyâropMUc g«os« aw«b« at << Mnalflewte* l«r»i i» roj«et*4*7«lm Xj /k-V la tb« critic»! v»la« of th« Polawn 41»trlbat-ioa for tlM •< plinifleaK* 1«*«1 «od k - 1 dtfroo» of «ro*o»»»It lo xxfd in tablo / 4V *h»r« ^ - q / 200»
$h« of th» paranatr A that ia «qoal to«oaa valut of thia fliatritmtian i * jivoa tgr:
«har* a j ia th« eantta of i - «laaa intcrral*
2.6,2. , fh» taat to v»rify th» fagrpothaaia forprobaMlitr alatrlbtttto* I A noaaar of «iaroorganiaaa on hydra»pallia ta?*a awaba «aa aamioi ant ia gat a aanaral laforaatlo*ty plottiuf tho data o» laft-aental papar.
danait^ of th» l o f aoraal diatribtttlaai la gLvom ayfonwlat
/la x "
far x >O
t M
• •' X'
of
2*6 «3«toditd
to
-. V
to FOpFtcoiitAto wtyj T flJTWT iwiiiÉPtiftfi 1jhj> t*>nfkmt T*V>1CT^ fsnoKtho Boiaal d io t^buUon i l t h p^»
lagr B«rt^ott*« toot•. 'iftor ' thO: dlfforoneo* i o aaan- yoloi», forindividual iwnt*»» ^ro; -;«volttâto*- tsgr •• di«pf jolon onoljoi», of, tho•iapXo 4Loporaioa aulyoi* : wo« ' e«tried out
Vc/, for
DM* of e«l«ul«tioiis aoo«rdliic ' to^^^-'';;'''-^r;;:,^:-r;.."-'-;-::";:\::-^..j.
of • • « *•!»»•• i« rt J»oUd i f ;
of ïl»V»rH5Mâ«epr 4l»til]buUo^
diff•!««»•' trttwi I A U McounU «ko fco^twlij i ndoal tn«te ;wM;«T«lu*tod 'kar; Co^f^
thl» to«t k ditporoloM caa )Mi o f :
l
o ':•• x
; hi-
_J
- 14 -
Table 1 : Characteristics for dispersion analysis
Month
1
••••i
*• , '•
* \ *
a=12
Value y i ;j
y i l « • • • ^ i i ^
y a l ' # # *» r an a
£ y?- -
ITumber oivalues
n l
*•••n i
•••na
N =
S 3H53
h.
••**
•••Y a .
Ï =• •
" i Y i -
Aeaa valu<
••••y i .
#•»
y . . =
n i
*ln i••••
*•
na
Y2
K = - " • =K
iliwïtere Y _ v n.
i i
i .
- 15 -
Table 2 : Dispersion analysis of simple classification
S
Saarce ofvariability
Betweenclasses
Error
Total
-Square sum
asA =L n i / y i—- / 2
a n-
Se= I I /yi ry ± /2
e i=l j=l 1J lm
i=l T=l
Number ofdegrees offfeeûoa
fA= a - 1
f e=r N - a
N-1
Meansquare
MSe= |s-=s2e
The teat criterion is:
C =/s?/
231 +
+ sn
where s| is the estimation of i- choice dispersion, i=l,2, ..*, k. baseâ on f degrees of freedom /f= 10-1 = 9/«The critical values C are noted in table /4V» The hypothesisfor dispersion equality is rejected if C C /k,f/.
- 16 -
. V
2.4.6» Confidence intervals were computed to evaluatethe fraction of test-pieces of hydrophilic gauze swabs thoseremained contaminated by microorganisms after exposure tosub-process doses of gamma radiation.
Confidence intervals were calculated for the fraction Or/for individual weeks and for various values of the dose D/ rijj was the mraber cf teat-pieces on those bacteria survivedthe dose of radiation D and OQ the number of control unir-radiated test pieces / •
fir,The confidence interval for S ^ has a form
where/ f
l ' V+nD
f l "
/ f /f /fl'V
F /f l f f2/ are the critical values of Fischer-
Snedecor's distribution with ^ and f degrees of freedomthose are noted in table /4V.
was
^^ $fipfi$ ; ^ ; of in«ctiT«tlon eurr» -; ; _
^ -
ofvlth «n
• .' *"• 'j '.- '" '" V '
• . ; « ? , . - . z ',*'
' - • V - - - , . , • \
- log»rltbffllc txiiMfOTMI
}}
r*lntiott / 1 / ' « f«t », ^ :
- 18 -
m m m
ni
fm
A ' (il, lnND.N Q = e
m
'; Carrelation between theoretical aad etapirical datain the relation. /2/ is expressed fcy coeficient of correlationr " between. D and In T>n,It holds:
ni m ni
r«-î=2
r^Cr) are «cfc criticalIf Irl > r^lT) , (rtf= m - 2,values of coeficient of correlation that is noted in table /AX/*Then the dependence In N D na D can be considered forstatistically significant.
XuBâtlT«tl«a curv« oxprtfosod ty «qtuitioa /3t/ «haraetoristdtoo roairtw&eo of •ioroorfanisa* foi* M oaUod * •*•* * **dioVion £»••*; Hi* nuafeor' of surviving xdoroorjgnnioa* i f «ftèii
*t dts«»n«ér tt *tr» than «ftrrti^oadiac to etlcalationsto «qiuitioa /3/« Sorti dtpftndcntt* ««a. b« s*r« proptrl?ty follotriac
Stt* «oiwtaDt « «barMUrtM» ooor«« of i»««tiT«tion c o mia r*fi»a of «i«U r*dl«tion dosait fi* SstjbiatioM Of pprwwtt»itt a «ad 9" wtrt coaput«d <*o« «quAtioa gkirott fo* £, »#
r a» d««<xibà4 abor», feat tMÙtd ^ th«/ 1^ v*» taktm M
a«foapala /4a/1
»-10,
*o - tel
- 1» th« doi« of radtrtio»,- ttttibor of «i«roorf«dBM iurritint «ho
differs from the theoretical one at 3% significance
level
* - deviation différa at 1% significance level
* 'V
• s f
,*g -
. -, *, ..: - - - ' * '"* >; *
ft
\>
tor• cwaomlation of point* to tb« ste^gjbt l in t 1» oxo«* « ^ « I ^ B J ^ - :by Montb^ia wWcb thé y bacttrial counU on t t i t -
1 ' :.'-/-
'•V-:*ia}fwa»- ; pf and «tadadard/È/ liMit* «r 95* cbnfid«nc«
lAt«j^*X for pa^aattilcal^ ^ «nd i t» «fitiMiiion7 ,«^,,:,'•ir« coApdtvd* A t oonftdtne* intcrral 1» for aa«ll TCLLOM of -v
' of tbl» di«tribution» !»•* for iwtr«^ nv»btr ofon «iaiHLt prodoet* of bydrophilic g«vw« iiwabii,
data «art *l^«n in Tigurt ï t in «td.eh
i ^ i ^ E i ; i s ^ ^ ft^r^%ië^ t î à i | Â à M ^ è ^ i ^ Ê :pblliewer*;tf«teâ,;'oa
^ out of the prod««in •èriabilitar i ^ i ^ indt^dual
in
by Cty * o n
oo» ««nth not found W b« «Uti^Ucklly • igo i f i cwt ,
of »••« T « 1 « « for
- 24 -
Table 5 : Estimations of mean value EX and standard deviationIfiX, lower D and upper H. limits of 95S? confidenceinterval for parametrical function e^ and itsestimation
f
Month
October
November- .
December
January
February
Week
1
2
345
1
2
34
12
1
234
12
34
AEX
104,39,37,
6,39,
24,104,
80 ,10 ,
1652
2154130
9
993
11
41270292
15
4282
20
68
,60
,01
,36,17,34,40
,36,34,71,67
98,23 ,40,
4 ,76,
16,57,
102,15
1360
388629
4
793
2 1
X
02
77231525
147785
,25
,16,37
,58,06
,76,49
,30,99,50,91
13
43,2 2 ,
13 ,3 ,7,
13,63,24 ,
3
317
1866
11
6
431
2
10
52169930
245036
,04
, 01
,53
,66,90,92,13
,50,42,34,44
H
134,4250,1147,711,1643,78
31,33132,7
99,8012,33
12,5465,73
240,7545,7339,4211,74
12,0811,925,44
13,76
76,33,2 5 ,
5,17 ,
2 0
9149
6
633
211
172 1
8
762
5
ty12
60
079488
,37, 80
,31,13
,15,95
,98,77,68,48
,37,38,70,78
Table 5 continues :
- 25 -
t
Month
Karch
April
.
Mgy
June
July
Week.
12
34
12
345
12
34
12
34
12
345
46,065,034,134,97
14,845,165,75
10,3921,92
31,0914,7537,558,53
36,5026,4913,6423,03
T9,7723,055,609,163,52
Vox
7,716,023,975,39
37,4511,885,02
16,7319,47
18,938,50
28,371,88
43,7619,1011,1618,84
26,2622,16
3,253,252,79
D
1,861,651,663,44
1,990,832,532,449,49
17,768,71
18,527,12
11,9013,536,33
10,37
60,229,413,066,751,68
H
7,566,34
10,646,11
15,025,537,42
12,3028,27
39,6818,7548,44
9,74
91,8931,1317,629,74
95,3229,807,65
11,054,57
3,8
3,232,974,59
5,462,144,335,48
16,39
26,5412,7829,95
8,33
23,3821,4910,5617,82
75,7616,744,848,632,77
- 26 -
Table 5 continues :
fMonth
August
Septemt
Week
1
23
er I23
EX
62,18111,9269,98
66,0842,4095,33
A
\fiaf
24,2035,6917,02
27,9722,8497,85
D
44,2985,3457,27
45,5026,0136,25
H
151,60133,2280,73
81,3655,51
122,04
57,95106,6368,00
60,8537,3266,51
- 27 -
t
Table 6 : Results of testing homogenity in variability ofpre-sterilization contamination for individualmonths and dispersion analysis
Month
OctoberNovemberDecember
JanuaryFebruary
March April
MayJuneJo""
A . tS f.K member
Values n^
494020
383840
50404050
30
30
Mean v«y^
3,153,312,673,38
1,741,30
1,68
2,842,86
2,39
4,324,05
1,40
1,68
1,642,18
1,03
0,641,38
0,64
0,641,650,16
0,61
Total: sA = 347,71Se = 524,05ST = 871,75
fe « 453MSA = 31,61MSe * 1,16
F/fA,fe/ = &/11.453/ =1,792* < - 0,05
reap.
e - . - v . ' - . — ' - 2,253** < = 0,01
- significance at 5 %, resp. 1 % level
- 28 -
Table 7 î Results of Cochran's tes t of dispersion homogenity
Month
October
November
December
January
February
Week
12345
1234
1
2
1234
1234
Mean 'X
4,33233,51453,22151,78122,8837
3,01394,51963,89811,8128
1,81643,5249
5,35652,87753,07632,1380
2,22061,85360,99421,9504
Sstimat.ofdispersion
40,63210,31230,77990,30681,5674
0,36260,26530,97271,1115
0,99250,8532
0,03161,68070,67250,2061
0,47500,76210,63531,4634
Test cri terion
C = 0,4356
C o > 0 5 / 5 ,9 / = 0,4241 *
C O,Ol / 5 > 9 / = °»4854
C = 0,4098
C 0 > 0 5 /4 ,9 / = 0,5017C o | o l / 4 , 9 / = 0,5702
C = 0,6487CO ) O 5 /2 ,9/ = 0,8010Co',Ol /2 '9/ = °'a574
Figure 1 : Pre-sterilization counts of microorganisms ontjydrophilic gauze swabs over the période fromOctober 1975 to September 1976
oar^ v : »iv .HH;1V'cn^f i ie i ir i i that rtault» of inditidaal. w*«k»;
d^f*r aijg^ficant^ in a --:.. diff*r aijpiificant^ ^ al l aonth« *T*r ^« p*riod* of on* • - ''C 3r*af at 5ft ai^odfieano» l«ir«lf r«ap«ctiv*ly at 10% in Jon* and
Sapt««b4»^ ^ f diffat*iW*a can b* «a* ^ la fi'gttr* 1.
ogieal
in
of •lcroorganiaa»t>T«r on» y«ar ar««ra«'.;r#ppi*tnt*d>'% cocci / 24 »
atrobic apor«-forai«« ro4« / 16,1 -
odntaainatfd produatf
oo»-
pariod* of on* 7*ar. Th* atti*«*ri«*d r*»»!** of individual-; ' '»ntto.,.iw ^t*^;>iattp«j^^-^:;^^*T^uati<>a_ of qàrt*r* and th* .; , total y«ar in tabl* 11» C*nfid*nc* MaA a lnt*rvala w»r* coiapuV
Figure 2 : Inactivation effect of increased sub-sterilizationdoses on the microorganisms on gauze swabs:summary of results of the 4th quarter 1975 anathe 1st quarter 1976
NdNo ,
0,8 •
0.6 -
0,4
02
IV. 1975
}] x I01 3 5 7 9 11 13 15 D(kJ/kg)
NdNo
1
0,8
0,6 Ï
0,4
Ï ÏI. 1976
J l01 3 5 7 9 11 13 15 D(kJ/kg)
- 38 -
Figure 3 Î Inactivation effect of increased sub-sterilizationdoses on the microorganisms on gauze swabs:summary of résulta of the 2nd and 3rd quarter 1976
No 1
0,8
0,6
0,4 1
0,2 1
} II. 1976
I I I 1 I I I I
01 3 5 7 9 11 13 15
NdNo
1
0,8 '
0,6 "
0,4 "
0,2 •
?? ç
i. 111.1976
Û01 3 5 7 9 11 13 15
- 3 9 -
Figure 4 : Inactivation effect of increased sub-sterilisationdoses on the microorganisms on gauze swabs:summary of results of the total year
Nd .No
0,8-
0,6
0,4 H
0,2-
Î Ï
] X I I0 1 3 5 7 9 11 13 15
D(kJ/kg)
V " ' ' • ' "
' : -;--i--.iTO»;çb.t iB«d;'>j«iaiat«, i v**^#^«*vt&«t th»
••rt.»T« \\A- a « n »vf l»>>nvhtt*L<<itty T'f th< '^•«ttf l i i <yf b o a i t i v a <rowtb: roaolta to Xbm;ii}iiaSi^:-wiii>M^of:- aaaploa ^ tcatèd i t plotttd «gaiaat
Str«lo» i»>l«t*â M tMt-pi«««« Of hydrophili»«««be tbCNM «tr« Irradiated tor «ob*#t«rilis*ttoaldmtifltd éa fe«i« of aorpbologiQAl «ad Pioeb«*i«alf*aa ttM total aawWr 1?T l*ol*tad «tvaiMy M «*r« Qraa po«ltiv«
rod» of twm Ba«lllMt 4» ctralna o»long#d t#*o«d m& X atealn of Qram o*gativ« r*i «lfavut roda of tb« typo
tn fabls 12 à ttateary of id«Atifltd atrala* iaolatadfro« CMS* Mraba irr*4l»t^ If %t % ? and 9 «*/kg /0,3-0,9 «rad/
- 41 -
Table 12 : Summary of strains isolated on irradiated gauze
la flyan* Tm« «aat laaUU* atiNrtJat a«oni •••«I aalonfat 1» Mlara-* I M N I l i t w / U / wt MltTMiiew m i w / T «train» / . As U .. tfc* «*WM B«dllto » ftw afcaalataly fraqaant tyna «M »•• / H »tr«l» / , l ^ t h » K ••bUll» / 1* «U*l«« / , 1./ 5 •twln»/ «>d ». «Mtte^iw/ 4 «tr«l»« / • « f
U tt* *»»» » M/l^ »— —frtT«d by f atraias taaaa *•?•• • » . »«bUU», • • ««rai», » . a a t a l — » » .
—rr»U* • • « t r i a . '. ; '-'! ';•' SS''•'' /:"-.^.^:. >-; "' / .<'/•''
IMM 7 M i I ,7 «< 0.» lr»V «t*
taX In aa4 aaltor—<rtai phaaphaf
;; HM MmUUM «HfltiMt f |lTM «tiiMN iMT « VU?>»laU»» #»twaaa tna éaae and naatar »f
- a% WAlaa
. ï»a aalMla—a far >otH «aattana / V and / V la ik' a i latralna v«qr alaar. Iha al«OflaaM« af vaaolta la alaaaat
af tka »atk «a«ala far naolan a»aas ara aUllar aa 1t.»f 1ka aanatant k. ï :;ÏU'"'"':":-.
.;/-. .; Tba aoMiant $ aaaraatvHMa raalaUaaa af tka aiadlat^W ^n^^^nna^na a a ^ p t'v^^a^aja^aj^i^^a^ 4n> ^p kfa>^vv ' • S^ni nT' ^a^^^pin^BH^ j^ av^a^a^fla^y^p^pm^^^^ _ v^ajup t a ^ ^ r a^Baa^p^paj^^pvvaj
ffea aetaal raalataaaa waa taflaanatt élattMtly ay aa^rlramantal
•wditieo», dri«t «ttlt«r««M it it
i l f«r tiM ruiitMH
UU M « 1 4 wd
rtlw, B. M*UU« « d ». M«*t«ri«B. B/ ««viral «trai*» • di»tU-•lM«id«r «y»««r«d «a lKMUf «U«tt «anrtft «tUr ite
'" «KMJ illu«tr«Ud
»« »f 4
«id
wd B » tbwi w m i a
f«r
13 «od U .wd <• AU
th« for
Table 13 : Data and constants of inactivation curves:Bacillus megaterium and Bacillus subtilis
c
dose
o
train
kJ/kg
0
3
'e
9
12
15
B. megat-^r4 urn 107phosphate
buf ~er
1
1 ,39 .10" 2
2,28 .10" 4
8,50 .10"°
1 ,09 . ! 0 ~ 9
2,13 . 10" '
drisd
1
1,89 .10"1
6,58 .10~2
1,63 .10""
2,02 . lO" '
5,04 .10"'
B. sub t i l i e 67phosphate
buffer
1
3,!0 .10"3
3,10 .10" '
9,5C .-,G~6
8,79 ;io~12
dried
1I
8,54 . 10 ' -
4,41 .10"-
3,75 .1C-"J
?,43 .1C"1
1,68 , I0" 5
-'
9•o
£>
fiM
C
r-iIIo
a
c
N o
k
r
sign.
n
k
r
sign.
m
D10( kJ/kg;
7,03 . 1 0 i 2
1,7158
0,9948
++
3,4.5
1,7158
0,9948
6
0,70
7,55 . Î 0 8
0,6142
0,9738
++
1 ,66
0,6142
0,9738
• 6
0,21
2,51 .101 2
1 ,6794
0,9991
++
2,81
1,6794
0,9991
-••+
6
0,74
- ; rj~ , ^ "
0,6301
0,9901
+ +
C,63O1
0,9901
-f+
6
0,28
- 45 -
Figure 5 t Inactivation curves of Bacillus negaterium andBacillus subtilis
Table Î4 : Data and constants of inactivation curves:îîicrococcus luteus and îîicrocoecas roseus
of o««t«d»«tid i%m» U à «1T«« p^O*U«a oflton» i» ?M«ttoA of tlM rtooo»
0«rof
of «orroUUom «f thi«U » t l ^ aisaiftoom* iorol.
io« of
twrro proYo» th»t ttao
im ttmm wm tut of M m t, th.
«r ttM
- ftVf
coat*Blnat«à gao*** »v*b*t«a»l on». Our »xp»ri.»ftc» f l t h 4po» coat*that i t T M p»»»ibl» to 'iptoilatti th* ttÇBibtr «Kifo6r*«ni«»8 • *•««pie» acc»rdip£ to th» lo^r»rii»2 probability dUtributlon or In••r«r«a ï*ek# ace«r<îing to th» «xpormvtt<mal ^«trtbutlon «hi* tb*di»tributian ww rraluat«d w»»fcljr ox«f th» p«rto4» of «s» yf «r. Tb«pr»ctlc« X dl««r«nee i s eo»p«ri»»m t» th« P»i»«ma«i attr ibut ionwould i^ptW to t*k« into «ottoont th« higher opp«r l ia i t» for tt»probabl* «pp»«r«et of »«ipl«« with »por»*ie hi«h e«ntt«itt«tioa;.
ofI t bj« b«»n «t»t*d that for ao<»t«adn«t«û with Mr«Utt«»« mitrovefaXmm m i»
lilctly to b« found i n fè««tîçfc r««l «stiMit«R ef tb« proportionof iU«« contMinattf om W *«»»ur^ only «t r«U-tt»«ly l«r r«4-i«ti»n <lo««a» S ir *M«pl«, in tbt «ztroia* of JJff «t «1. A 8 / M
t wm* not«4 to«t tk« hi«bt»t 409tof th» eoat«anat«ii proportion was 0.5
Mr«d «nd for «ottotv «>U», WtïE /20 / fooad th i . .«<>•• to b« O.jfMr«d. i n «or *xp*ri««at« tt» do»» »n»blii« U n M u n «to «oatwl»-•t»d fraction or proportion ••» con«ld»r»bly h igb« «nd r*%h«d 1.1Mrad / 3 r * 3 / i ^ «|el# fMt WM ». «on»Wo«aM «f ^
- »t«rms»Uon contamination, • * . I s 'iL. -*
tALLBNTTM »t »1» / 2 V tloe that th» r»»*OB. f *r th»r»»tri«|i»n tt th» proporUé» «
à Mi»*i4»raUo« »f th» «*to*4«BTT» r»Utin« »mar«i pi oportioa / d«nt«MiAat«< fracUoo/ « ido«» / » / »T«r Bnli«it«d T«^O.» »f ». thi» «imf » i i l fmU
to • £•»• irtMr* tto» p»portl<» «ppwaiwi^»f «*t«*Nttta* *f * f ^ f pwiUTW la