TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
VALIDATION PROTOCOL OF ETHYLENE OXIDE STERILIZATION PROCESS
Company Name
Eto Sterilizer man!a"trer name# Date o! Pr"$a%in Date o! In%tallation# 'o(el nm)er# Capa"ity# Operator Name# Department *Pla"e+
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
Table Table of Contents 1. 2. 3. 4. 5. 6. !. ".
PROTOC PROTOCOL OL APPRO APPROVA VAL L SHEET... SHEET........ .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ............ ................... ...................4 .......4 REVISIO REVISION N HISTORY HISTORY..... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .............4 ........4 OBJECTIV OBJECTIVE:-. E:-...... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .................. ......................... ............... ...5 5 SCOPE:SCOPE:-..... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ............5 .......5 RESPONS RESPONSIBIL IBILITY ITY:-. :-...... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ........... .................. ..................5 ......5 STAN STANDAR DARDS DS FOR REGULA REGULATO TORY RY REQUIRE REQUIREENT ENT::-......... -.............. .......... .......... .......... .......... ................. .......................5 ...........5 LIST OF DOCUENT DOCUENTS:-. S:-...... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ............. ................6 ........6 PRE-REQ PRE-REQUISI UISITE:TE:-..... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ................ ....................... ....................6 ........6 E#$%&'()* E#$%&'()* #$+,%%+*%/).................... #$+,%%+*%/)............................................... ...................................................... .......................................................... ............................... ... 6 C+,%0+*%/):...........................................................................................................................6 P/$* #$+,%%+*%/).................. #$+,%%+*%/)............................................. ...................................................... ....................................................... ........................................ .............. 6 P/$* +) &++%) '+*(%+, (+,$+*%/)........................................ (+,$+*%/).................................................................... ............................ ...... 6 P/$* /$&%)........................ /$&%)................................................... ...................................................... ........................................................ ............................. ....... 6 S(,(*%/) S(,(*%/) / +'%, (&(7()*+*%(........... (&(7()*+*%(...................................... ...................................................... ................................................. ...................... ..! .. !
8.
P/(77 P/(77 +) V+,%+ V+,%+*%/) *%/) A&&/+ A&&/+9:9:-..... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ............ ................... ..............." ..." P/(77 V+,%+*%/) P/($(:P/($( :-................................................................................................8 ................................................................................................8 B%/0$() B%/0$() +77(77'()*.................... +77(77'()*............................................... ...................................................... ...................................................... ................................... ........ 8 S(,(*%/) S(,(*%/) / P/(77 C9+,,()( C9+,,()( D(%( PCD.......................................... PCD.......................................................................... ................................ 8 BI / PCD &,+('()* %) *9( &/$* ,/+: -............................................. -.......................................................................... ............................. ....8 .... 8 T('&(+*$( T('&(+*$( +) H$'%%* 7()7/ %) &/$* ,/+:....................................................... ,/+:....................................................... ........... 8 L/+ T('&(+*$ T('&(+*$(.................... (............................................... ...................................................... ................................................................... ........................................ 1; I()*%%+*%/) I()*%%+*%/) / *9( 7* +7( ,/+*%/) / /, 7&/*...................................................... 7&/*...............................................................1; .........1; P/(77 Q$+,%%+*%/) R$)7....................................................... R$)7................................................................................................. .......................................... ... 1; +=
H+, C,( C,( (*9/.. (*9/....... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... ................. .....................1; .........1;
0=
B%/0$( B%/0$() ) >BI '(*9/. '(*9/...... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .................12 ............12
+%)*+%)+( +%)*+%)+( / V+,%+*%/):....... V+,%+*%/):.................................. ...................................................... ................................................ ..................... ............. ........... ..14 14
R(#$+,%%+*%/)............. R(#$+,%%+*%/)........................................ ...................................................... ...................................................... .............................................. ................... ... 14 1;. S+'&,%) S+'&,%) '(*9/ '(*9/ +) *(7* '(*9/:'(*9/:-..... .......... .......... .......... .......... .......... .......... .......... .......... ........... .................. ......................... ................14 ...14 LIST OF TEST TO BE E?ECUTED..................... E?ECUTED................................................ ...................................................... ........................................ ............. 14 12.P/(77 12.P/(77 &++'(*( &++'(*( 9( 7*(&7.................................... 7*(&7............................................................... ........................................................ ............................. 16 E)%/)'()*+, E)%/)'()*+, &(/)%*%/)%): &(/)%*%/)%): -..................................................... -............................................................................................ ....................................... 16 I)%*%+, (+$+*%/): -............................................................. -........................................................................................ ....................................... ........................ .............. 16
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
H$'%%%+*%/): -.......................................................................................................... ........... 1! G+7 %)@(*%/) +) +7 <(,,: -....................................................................................... ......... 1! P/7* (&/7$( +7 &$( +) +% %) 0,((: -........................................................................... 1" H(+*( +(+*%/): -..................................................................................................... ............. 1" A&&()% 1 S%'$,+*%/) / A)*%%&+*( P/(77 C/)%*%/)7.................................................... .....21 A&&()% 2:- D(*('%)+*%/) / B%/0$()......................................................................... ......... 22 D(*('%)+*%/) / B%/0$()....................................................................................................... 22 A&&()% 3GLOSSARY=........................................................................................................... 23
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
,- PROTOCOL APPROVAL SHEET T9( V+,%+*%/) P/*//, 79+,, 0( P(&+( R(%(<( +) A&&/( 0 *9( /)()( &(7/))(,. I* 79+,, 0( 7%)( +) +*( +7 79/<) 0(,/<. Prepare( )y# NA'E
DESI.NATION A77%7*+)* '+)+(- QA+,%+*%/)=
SI.NAT/RE
DATE
SI.NAT/RE
DATE
SI.NAT/RE
DATE
C$e"0e( )y# NA'E
DESI.NATION
Appro1e( )y# NA'E
DESI.NATION
2- REVISION HISTORY
REVISION
;1
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REVISION DATE
REASON FOR REVISION3CHAN.E RE4/EST O%%)+, (,(+7(
REVISED 5Y
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
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er%on V+,%+*%/) *(+'
Re%pon%i)ility P(&++*%/) / &/*//, O+)%+*%/) / +,%+*%/) +*%%* C/,,(*%) *9( 7+'&,(7 +) 7()%) */ QC R(%(< +) %)*(&(*+*%/) / %)+, (7$,*7 P(&++*%/) / (&/* R(%(< / &/*//, +) (&/* Q$+,%* /)*/, A)+,%) *9( *(7* 7+'&,(7 R(&/*%) +) %)*(&(*+*%/) / (7$,*7 P/$*%/) R(%(< / &/*//, +) (&/* C/)$*%) *9( +,%+*%/) +*%%* +7 &( *9( &/*//, Q$+,%* +77$+)( '+)+( R(%(< +) +&&/( *9( +,%+*%/) &/*//,
;- STANDARDS FOR RE./LATORY RE4/IRE'ENT#8 •
•
•
ISO 11135-1:2;;! S*(%,%+*%/) / 9(+,*9 +( &/$*7- E*9,()( /%(- P+* 1: R(#$%('()*7 / ((,/&'()* +,%+*%/) +) /$*%)( /)*/, / + 7*(%,%+*%/) &/(77 / '(%+, (%(7 ISO 1;883-! B%/,/%+, (+,$+*%/) / '(%+, (%(7- P+* !: E*9,()( /%( 7*(%,%+*%/) (7%$+,7 ISO 11!3!-1 S*(%,%+*%/) / '(%+, (%(7 %/0%/,/%+, '(*9/7 P+* 1: D(*('%)+*%/) / + &/&$,+*%/) / '%//+)%7'7 /) &/$*7
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
•
•
ISO 11!3!-2 S*(%,%+*%/) / '(%+, (%(7 %/0%/,/%+, '(*9/7 P+* 2: T(7*7 / 7*(%,%* &(/'( %) *9( +,%+*%/) / + 7*(%,%+*%/) &/(77 ISO 1;883-1:2;;2 B%/,/%+, (+,$+*%/) / '(%+, (%(7 P+* 1: E+,$+*%/) +) *(7*%)
<- LIST OF DOC/'ENTS#8 • • • • • •
SOP / (*9,()( /%( 7*(%,%+*%/) &/(77 SOP / ()%/)'()*+, '/)%*/%) SOP / 7+'&,%) &/($( SOP / *(7*%) '(*9/ SOP / '+*(%+, 9+),%) %),$%) 0%/,/%+, %)%+*/ S*(%,%+*%/) ,( &++'(*( 7&(%%+*%/) 79((*
=- PRE8RE4/ISITE#8 T9( /,,/<%) (#$%7%*( '$7* 0( $,%,,( 0(/( *9( (*9,()( /%( 7*(%,%+*%/) &/(77 +,%+*%/). E>ipment >ali!i"ation:E#$%&'()* +77/%+*( <%*9 (*9,()( /%( 7*(%,%+*%/) &/(77 '$7* 0( #$+,%%( &%/ */ &/(77 #$+,%%+*%/). Calibration: - A,, &/(77 7()7%) /)*/,,%) %)%+*%) +) (/%) (%(7 /) *9( 7*(%,%( / %)(&()()* 77*('7 +77/%+*( <%*9 7*(%,%( '$7* 0( +,%0+*( +) (/(. C+,%0+*%/) &/+' '$7* 0( /$'()*( +) (*+%,( &/($( / +,%0+*%/) (#$() / +,, *9( %)7*$'()*7 79/$, 0( %()*%%(. Pro("t >ali!i"ation:Product and packaging material evaluation : - As &( ISO 11135 &/$* +) &++%) '+*(%+, '$7* 0( (+,$+*( / (*9,()( /%( +) 9$'%%* &()(*+*%/). Product grouping : - F/ (%%()* +) /7* ((*%( &(/'+)( +,%+*%/) 7%'%,+ (%( +) 0( /$&( %) */ +'%,%(7. A +'%, / &/$*7 +) 0( /)7%(( */ 0( +,, *9/7( &/$*7 / 7%'%,+ (7%) +) '+*(%+, / /)7*$*%/) 7%'%,+ 0%/0$() ,((,7 0$* +) 0( /)7%7* / %(()* 7%(7. D(%(7 +) 0( /$&( 0+7( /) 7((+, %*(%+: •
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S%'%,+%* / '+*(%+,7 / /)7*$*%/)
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
•
S+'( &/$* (7%) / %(()* 7%(7 ,()*97 / *9%)(77
•
D(7%) /'&,(%*
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S%'%,+ '(*9/ / '+)$+*$(
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Selection of family representative : - E+9 +'%, / &/$*7 <%,, /)*+%) + )$'0( / (%(7. F/' *9(7( (%(7 *9( (&(7()*+*%( 9+,,()( &/$* %7 7(,(*(. T9( 7(,(*( (%( <%,, &(7()* + (+*( 9+,,()( */ *9( 7*(%,%+*%/) &/(77 +) <%,, 0( *9( '/7* %%$,* */ 7*(%,%( (%( %) *9( +'%, /$& +) <%,, 0( $7( +7 *9( BI +%(. F/,,/<%) %*(%+ +) 0( $7( */ 7(,(* *9( +'%, (&(7()*+*%(:-
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L/)(7* *$0%) <%*9 *9( 7'+,,(7* ,$'()
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/7* ()7( &++( /)%$+*%/)
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
?- Pro"e%% an( Vali(ation Approa"$#8 Parameter% to )e Veri!ie(
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
-
P/(77 V+,%+*%/) P/($(:- 5io)r(en a%%e%%ment: - A) $)(7*+)%) / *9( &/&$,+*%/) / %+0,( '%//+)%7'7 /) + %)%79( (%( 0%/0$()= %7 )((77+ +) (#$%( */ 7$&&/* *9( +,%+*%/) &/(77. T9( 0%/0$() +77(77'()* %),$(7 *9( */*+, )$'0( / '%//+)%7'7 <%*9 *9(% %()*%*%(7. T9( %()*%%+*%/) )((7 /)%'+*%/) / +' 7*+%) 9++*(%7*%7 +) ()$7. I* &/%(7 $7($, %)/'+*%/) +) +) 0( $7( */ '/)%*/ 9+)(7 /( *%'( +) +7 + /'&+%7/) */ /+)%7'7 (/(( $%) ()%/)'()*+, '/)%*/%). F/ (*('%)+*%/) / 0%/0$() R(( */ Appen(i@ 2
Sele"tion o! Pro"e%% C$allen&e De1i"e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
5I or PCD pla"ement in t$e pro("t loa(# 8 A*( *9( &/$* ,/+ 9+,,()( 9+7 0(() %()*%%( *9( BI / PCD &/7%*%/)%) +) &,+('()* +) 0( (*('%)(. BI7 +) PCD7 79/$, 0( %7*%0$*( *9/$9/$* *9( &/$* ,/+ +) +7 '$9 +7 &/77%0,( %) *9( 7+'( /%()*+*%/) (.. (*%+,=.
F/,,/<%) '%)%'$' )$'0( / BI7>PCD7 */ 0( %),$( %) (+9 +,%+*%/) ,( +7 &( ISO 11135-1: 2;;!=:•
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U& */ 1; '3 *9( )$'0( / BI7 %7 ' 3 <%*9 + '%)%'$' / 5. F/' 1; ' 3 $& */ 1;; ' 3 *9( )$'0( / +%*%/)+, BI7 %7 /)( &( +%*%/)+, $0% '(*(.
Temperatre an( Hmi(ity %en%or in pro("t loa(# - F/ 9$'%%* 9( %) &(/)%*%/)%) +) /)%*%/)%)>7*(%,%+*%/) /)( 9$'%%* 7()7/ &( 2.5 ' 3 <%*9
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
'%)%'$' )$'0( / 7()7/ %7 * 79/$, 0( &,+( %) 7*(%,%+*%/) ,/+ +) %* 79/$, %),$( &+,,(* ()*(7 ((7 +) 7$+(7. F/ *('&(+*$( '/)%*/%) %) +,%+*%/) /)( *('&(+*$( 7()7/ &( $0% '(*( / &/$* /,$'( <%*9 + '%)%'$' / 3 7()7/7 79/$, 0( &,+( %) *9( ,/+. Loa( Temperatre: - ISO 11135-1:2;;! (#$%(7 *9+* *9( '%)%'$' *('&(+*$( / &/$* &('%**( */ ()*( &(/)%*%/)%) 0( (*('%)(. L/+ *('&(+*$( &%/ */ ()*+)( */ &(/)%*%/)%) 79/$, 0( (*('%)( +* *9( ,/<(7* *('&(+*$( /)(. D%(* &,+('()* / /, ,/+7 %)*/ &(/)%*%/)%) +) (7$,* %) ((77%( <+*( /)()7+*%/) +) ,/+ <(**%) <9%9 +) +$7( &/$* +'+( +) ($( ,(*9+,%*. I) &/(77 +,%+*%/) %* (#$%(7 */ 7%'$,+*( *9( 7* /)%*%/) */ <9%9 *9( ,/+ <%,, (( 0( (&/7(. T9( +)*%%&+*( ,/+ *('&(+*$( (*('(7 +) 0( 7%'$,+*( $%) +,%+*%/) 0 /,,/<%) *(9)%#$(7 (7%0( %) *9( +&&()%(7 1. I(enti!i"ation o! t$e or%t "a%e lo"ation or "ol( %pot : - *('&(+*$( %7 *9( (+7%(7* +%+0,( */ '(+7$( +) '/)%*/ *9((/( *('&(+*$( %7 $7( +7 +) %)%+*/ / *9( 7* +7( ,/+*%/) %) *9( 7*(%,%+*%/) ,/+. D$%) *9( &(/)%*%/)%) / /)%*%/)%) &9+7( *('&(+*$( &/%,( ++%)7* *%'( / *9( 7*(%,%+*%/) ,/+ '(+7$( +) 0+7( /) *9+* +*+ *9( 7* +7( ,/+*%/) / /, 7&/* %7 %()*%%(.
Pro"e%% 4ali!i"ation Rn%:-
F/ +,%+*%/) + '%/0%+, 9+,,()( <%,, 0( &(/'( */ ('/)7*+*( *9( +(#$+ / *9( &/(77 */ +9%(( *9( (7%( S*(%,%* A77$+)( L((,. T '(*9/7 +( $7( += H+, ,( '(*9/ O(%,, +&&/+9= 0= B%/0$() > BI '(*9/
a) Half Cycle Method : - D$%) *9( 0%/0$() +77(77'()* % 9++*(%+*%/) / 0%/0$() %7 )/* &(/'( +) *9( 0%/0$() ,((, %7 '/( *9+) 1;; CFU *9+) *9( /,,/<%) 7*(&7 +( &(/'(. I) *9%7 '(*9/ /)( +*%/) ,( 3 /)(-9+, ,( +) /)( $,, ,( %7 &(/'(.
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
P,+( B%/,/%+, I)%+*/ BI= <%*9 1; ⁶ 7&/(7 / B+%,,$7 +*/&9($7 %) *9( PCD7 +) &/$* 7+'&,(7 %) (+9 &+,,(* <%*9 9$'%%* +) *('&(+*$( 7()7/. P,+( PCD7 */ /, 7&/* / *9( &/$* ,/+=
L/+ &+,,(*7 / 7*(%,%+*%/) ,/+ %) */ *9( 7*(%,%+*%/) 9+'0(
R$) +*%/)+, ,( +/%) */ &(7%0( ,( &++'(*( U7( / ⅙ +7 (&/7$( *%'( *9+) $,, ,(=
A(+*( *9( &/$*
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P(/' 7*(%,%* *(7* /) &/$* 7+'&,( +) BI7. A%*%/)+,, &(/' B+*(%/7*+7%7>F$)% 7*+7%7 *(7* /) *9( &/$* 7+'&,(.
I &/$* 7*(%,%* 7+'&,(7 79/< 7$%+, (&(+* *9( $) /) )(< ,/+ <%*9 (,(+*( +7 (&/7$( *%'( $)*%, )/ 7$%+, %) &/$* +) /<*9 %) BI (+,$+*%/) / BI +&&/&%+*()(77=
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R('/( *9( &/$* 7+'&,( +) PCD7 +) &(/' 7*(%,%* *(7* /) &/$* 7+'&,( +) BI7
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
S*(%,%* *(7* 79/$, 79/< )/ /<*9 / 0/*9 &/$* +) BI7 7+'&,(7
P(/' /)( $,, ,( /$*%)( &/(77 (&/7$( *%'(= /) *9( +(+*( 7*(%,%+*%/) ,/+. P,+( +%*%/) &/$* 7+'&,( / *9( +%*%/)+, *(7*.
A(+*( *9( ,/+
R('/( *9( &/$* 7+'&,( +) PCD7 P(/' /,,/<%) *(7* /) &/$* 7+'&,( 1. LAL *(7* &/() *(7*= 2. P/$* +) &++%) $)*%/)+,%* *(7* 3. B%//'&+*%0%,%* *(7* 4. E*9,()( /%( (7%$( *(7* b) Bioburden B! method : - T9%7 '(*9/ (#$%(7 *9+* 0%/0$() ,((, 0( ('/)7*+*( */ 0( (,+*%(, /)7%7*()* /( *%'( +) *9( (7%7*+)( / *9( 0%/0$() 0( 79/<) */ 0( (#$+, */ / ,(77 (7%7*+)* *9+) *9( (7%7*+)( / *9( 0%/,/%+, %)%+*/. D$%) *9( 0%/0$() +77(77'()* % *9( 9++*(%+*%/) / 0%/0$() &(/'( +) ,((, / 0%/0$() %7 ,(77 *9+) / (#$+, */ 1;; CFU <9%9 %)%+*%) + ,(77( 9+,,()( *9+) *9( BI *9+) *9( /,,/<%) 7*(&7 +) 0( /,,/<(. E7*+0,%79 7* +7( ,/+*%/) %) *9( &/$* ,/+ 0+7( /) *('&(+*$( %7*%0$*%/) +) 9$'%%* / ,/+
P,+( BI <%*9 )/<) +'/$)* / '%//+)%7' %) *9( PCD7 *('&(+*$( +) 9$'%%* 7()7/
P(/' 5 +*%/)+, ,(7 <%*9 +( (&/7$( *%'( (.. ; 4 " 12 16 '%)$*(7=
Page 12
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
A(+*( *9( ,/+ P(/' 7*(%,%* *(7* /) BI
C+,$,+*( +*( / %)+*%+*%/) D +,$(= $7%) 7$%+, $( / +*%/)+, )(+*%( '(*9/
C+,$,+*( 9+, ,( +) $,, ,( (&/7$( *%'(
P,+( &/$* 7+'&,( +) PCD7 %) (+9 &+,,(* <%*9 *('&(+*$( +) 9$'%%* 7()7/
R$) 3 9+, ,( +/%) */ &(7%0( ,( &++'(*(
A(+*%/)
R('/( &/$* 7+'&,( +) PCD7. P(/' 7*(%,%* *(7* /) &/$* 7+'&,( +) BI7. A%*%/)+,, &(/' $)% 7*+7%7> B+*(%/7*+7%7 *(7*.
P(/' /)( $,, ,( /$*%)( &/(77 (&/7$( *%'(= /) *9( +(+*( 7*(%,%+*%/) ,/+. P,+( +%*%/) &/$* 7+'&,( / *9( +%*%/)+, *(7*.
A(+*( *9( ,/+ +) ('/( *9( &/$* 7+'&,( +) PCD7
P(/' /,,/<%) *(7* /) &/$* 7+'&,( 1. LAL *(7* &/() *(7*= 2. P/$* +) &++%) $)*%/)+,%* *(7* 3. B%//'&+*%0%,%* *(7*
Page 13
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
4. E*9,()( /%( (7%$( *(7* •
'aintaina"e o! Vali(ation#"e#ualification : 1. A) 7%)%%+)* 9+)( %) &/$* '+)$+*$%) &/(77 &++%) 7*(%,%+*%/) (#$%&'()* / &/(77 &/$* ,/+%) / ()7%* '+ )((77%*+*( (#$+,%%+*%/). A /$'()*( /'+, (%(< / +) 9+)( 79/$, 0( $)(*+() */ '+( *9%7 (*('%)+*%/). 2. T/ ()7$( /)*%)$( /)*/, &(%/% (&(*%*%/) +))$+,, %7 (/''()(= / +,, / &+* / *9( &(/'+)( +,%+*%/) 79/$, 0( /)7%((.
,B- Samplin& met$o( an( te%t met$o(#8 •
S+'&,%) '(*9/:S+'&,( *+() / +,%+*%) 7*(%,%+*%/) &/(77 79/$, 0( (&(7()*+*%( / ()*%( 0+*9 +) %* 79/$, 0( *+() /' '/7* %*%+, &+* / ,/+ /)%$+*%/). S+'&,( '$7* 0( *+() /' (+9 7(&++*( &++%) 77*(' &,+( /).
LIST OF TEST TO 5E EXEC/TED No Te%t O)e"ti1e 1 Bioburden T/ 9( *9( ,%+0,( '%/ /+)%7' determination %) *9( &/$*. 2 P/$* S*(%,%* T(7*%) %7 Sterility testing (*('%)( +) %+0,( '%//+)%7'7 ('+%) /) &/$* $%) 7*(%,%+*%/) 3 Biological !ndicator T/ 9+,,()( *9( 7*(%,%+*%/) $esting &/(77 +) +( $7( $%) +,%+*%/) +) /$*%)( &/(77%). 4
%ungi stasis Bacteriostasis
5
&'& test
6
Product package functionality test
!
Product functionality T/ (+,$+*( *9( 9+)(7 %) *9(
Page 14
T/ (*('%)( *9( (/( &(()*+( '%/0%+, /<*9 +) <%,, 0( $7( */ /(* B%/0$() (7$,*7. T/ (*('%)( E)/*/%) ,((, &/()-() &/$* / +' )(+*%( 0+*(%+= T/ (+,$+*( *9( /$*( &++%) / + (%(.
Re!eren"e% AS ISO ,,<6<#, an( ISO ,,<6<#6 AS ISO ,,<6<#2
ISO,,,6?#2BB;
AS ISO ,,<6<#,
T.O NO- :B /SP *,;,+ *=:+ ISO ,,;B<8,
ISO ,,;B<8,
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
!
"
test
&/$* 9++*(%7*%.
Biocompatibility o Cytoto(icity test o Biodegradation test o Carcinogenicity test o Sensitiation test o !rritation test *thylene o(ide residue test
B%//'&+*%0%,%* *(7*%) %7 ()7$( *9+* 7*(%,( (%(7 +( /'&+*%0,( <%*9 0%/,/%+, 77*('7
ISO ,B??68,8 ? to ,2
T/ ()7$( *9( +'/$)* / (*9,()( /%( (7%$+, ,((,7 +( <%*9%) ,%'%*7.
ISO ,B??68<
,,- Te%t re%lt an( a""eptan"e% "riteria#8 N/.
T(7*
A(&*+)( %*(%+
1
Sterility $esting
N/ G/<*9 / &/$* 7+'&,(
2
Biological !ndicator F+*%/)+, ,(7:Sterility $esting N/ /<*9
T(7* (7$,*7
H+, C,(7:
N/ /<*9
F$,, C,(7:
N/ /<*9
A,, &/7%*%( /)*/,7 '$7* 79/< /<*9 3 4
5 6
%ungi stasis Bacteriostasis &'& test
$7* 0( )(+*%(
Product Package %unctionality $est Product %unctionality $est
P++%) %)*(%* '$7* 0( %)*+*
Page 15
E)/*/%) +) &/() '$7* 0( +07()*
P/$* 79/$, )/* 79/< (++*%/) %7/,/+*%/) &97%+, 9+)(7
+) +)
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
! "
8
Biocompatibility $est *thylene +(ide "esidue $est
P/$* '$7* 0( 0%//'&+*%0,(
Process parameters
A,, &++'(*( '$7* '((* 7&(%%( ,( &++'(*(7
E*9,()( /%( (7%$( ,((,7 '$7* 0( %) ,%'%* +* *9( + / (,(+7( <%*9
,2- Pro"e%% parameter "$e"0 %tep%:En1ironmental pre"on(itionin 8 Parameter% to )e "$e"0e(
A*$+,
S&(%%+*%/)
$emperature of preconditioning room Humidity of the preconditioning room ,uration of preconditioning
A(&*+)( C%*(%+ '(* (7> )/ C/''()*7:
V(%%( 0:
D+*(:
Initial e1a"ation# 8 Point o! "on%i(eration $he evacuation ratevacuum) to maintain the seal integrity 'mount of negative pressure .umber of .itrogen /ash
Page 16
A*$+,
S&(%%+*%/)
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
A(&*+)( C%*(%+ '(* (7> )/ C/''()*7:
V(%%( 0:
D+*(:
Hmi(i!i"ation# 8 Point o! "on%i(eration
A*$+,
S&(%%+*%/)
&evel of moisture Heat
A(&*+)( C%*(%+ '(* (7> )/ C/''()*7:
V(%%( 0:
D+*(:
.a% ine"tion an( &a% (ell# 8 Point o! "on%i(eration 0as concentration ,uration of e(posure
Page 17
A*$+,
S&(%%+*%/)
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
A(&*+)( C%*(%+ '(* (7> )/ C/''()*7:
V(%%( 0:
D+*(:
Po%t e@po%re &a% pr&e an( air in )lee(# 8 Point o! "on%i(eration
A*$+,
S&(%%+*%/)
N$'0( / N%*/() <+79 V+$$' +*(
A(&*+)( C%*(%+ '(* (7> )/ C/''()*7:
V(%%( 0:
D+*(:
Heate( aeration# 8 Point o! "on%i(eration $emperature of room 'eration duration
Page 18
A*$+,
S&(%%+*%/)
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
A(&*+)( C%*(%+ '(* (7> )/ C/''()*7:
V(%%( 0:
Page 19
D+*(:
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
Page 20
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
Appen(i@ , Simlation o! Anti"ipate( Pro"e%% Con(ition% A)*%%&+*( ,/+ *('&(+*$( (*('(7 $%) *+)7&/* 9+),%) +) 7*/+( +) 0( 7%'$,+*( 0 /,,/<%) *(9)%#$(7:-
!3 /%e o! "ol( %tora&eF/ (+'&,( *9( &/$* ,/+ %7 7*/( $)( (%(+*%/) / (,%0(+*(, %)$( /, *('&(+*$(. T9( *('&(+*$( / *9( 7*/+( +(+ 79/$, 0( ,(77 *9+) / (#$+, */ *9( ,/<(7* *('&(+*$( *9( &/$* %7 (&(*( */ 0( (&/7( */ *9/$9/$* *9( (+. P/$* *('&(+*$( +*+ +( (/( $%) *9( 7*/+( *%'(. T9( *%'( %) 7*/+( 79/$, 0( (#$+, */ / (+*( *9+) *9( '+%'$' *%'( +) &/$* ,/+ %7 (&(*( */ (%7* $)( 7$9 /)%*%/)7 / *9( '+%'$' &/$* *('&(+*$( <9%,( %) 7*/+( 0(/'(7 *9( '%)%'$' +(&*+0,( &/$* *('&(+*$( / + ,/+ */ 0( +'%**( */ *9( &(/)%*%/)%) &9+7(. T9%7 +&&,%(7 */ &(/)%*%/)%) / */ /)%*%/)%) <9() &(/)%*%/)%) %7 )/* $7(. T9( $7( / (%(+*%/) +) (7$,* %) $)(+,%7*%+,, ,/< 9$'%%* ,((,7 <%*9 *9( (7$,*+)* (7%+*%/) / *9( ,/+. A (7%+*( ,/+ +) 0( '$9 '/( %%$,* */ 7*(%,%( *9+) + )/)-(7%+*( ,/+. b3 Temperatre mo(elin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ea%onal 1ali(ation&(/)%*%/)%) +,%+*%/) +) *+(* *9/7( 7(+7/)7 *9+* &(7()* *9( '/7* (*('( *('&(+*$( +) 9$'%%* /)%*%/)7. F/ (+'&,( + +,%+*%/) /)$*( $%) *9( /,(7* &+* / *9( (+ <9%9 $, +,7/ &(7()* *9( ,/<(7* +'0%()* 9$'%%* ,((,= /$, %(, '%)%'$' &(/)%*%/)%) &++'(*(7 +,% / /$*%)( &/$*%/) ,(7 $%) *9( ()*%( (+. H/<(( %) +7(7 / +,%+*%/)7 &(/'( $%) *9( 7$''( %* %7 +%7+0,( */ +,%+*( *9( &(/)%*%/)%) &/(77 <%*9 7%'$,+*( /, 7*/+( '+*9('+*%+, '/(,%) / */ (&(+* *9( &(/)%*%/)%) +,%+*%/) +* ,(+7* /)( $%) *9( <%)*( */ /)%' *9( +,%%* / *9( &++'(*(7.
Page 21
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
Appen(i@ 2#8 Determination o! 5io)r(en Determination o! 5io)r(en:P/$( *() 1;= (+9 &/$* 7+'&,(7 +)/', /' *9(( 3= %(()* 0+*9(7 / /$*%)( &/$*%/) &/(77(7. S() */ +&&/( *(7* ,+0 / 0%/0$() (+,$+*%/) ()$'(+*%/) / +(/0(7 $)$7 +) 7&/(7.= A* *9( *(7* ,+0 &(/' *9( 0%/0$() (*('%)+*%/)7 $7%) + 7*+)+ '(*9/ +7 /$*,%)( %) IS; 1 1!3!-1 0 (*+*%) (+9 (%( %)%%$+,, +) %,*(%) *9( (*+* *9/$9 + 7*(%,( 0+*(%+, (*()*%( %,*(. A +,%+*%/) / 0%/0$() (/( 79/$, 0( &(/'(. A) +%*%/)+, %( )/) 7*(%,( 7+'&,(7 +( (#$%(.= D(*('%)( *9( +(+( 0%/0$() &( (%( / (+9 ,/* +7 <(,, +7 *9( /(+,, 0+*9 +(+( 0%/0$() C+,$,+*( *9( /(+,, +(+( 0%/0$(). I + 7&%( + 7%),( +,$( +* ,(+7* 2 X *9( /(+,, +(+(= /$7 *9( 7&%( +,$( '+ 0( $7( +*9( *9+) *9( +(+( / *9( ,( 7(,(*%/). Sample item portion *SIP+ met$o( !or )io)r(en (etermination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•
•
•
•
•
T9( +,$( / SIP +) 0( +,$,+*( /) *9( 0+7%7 / ,()*9 '+77 /,$'( / 7$+( +(+ 5a%i% !or SIP Pro("t L()*9
T$0%) /)7%7*()* %+'(*(=
+77
P/<(7 G/<)7 I'&,+)*7 +07/0+0,(=
V/,$'(
F,$%
S$+( +(+
I'&,+)*7 )/)-+07/0+0,(= T$0%) +%+0,( %+'(*(=
Page 22
TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
Appen(i@ 6*.LOSSARY+ ETHYLENE OXIDE STERILIZATION .LOSSARY B(,/< %7 +) +,&9+0(*%+, ,%7* / *('7 *9+* '+ 0( $7( %) %7$77%/)7 / (*9,()( /%( EO= 7*(%,%+*%/) +7 (/)%( 0 '(%+, (%( '+)$+*$(7 %)7&(*( 0 *9( U.S. FDA. A,, (%)%*%/)7 / (&,+)+*%/)7 +( */ 0( *+() +7 +&&,%( 7&(%%+,, %) *9( /)*(* / EO 7*(%,%+*%/) &/(77%). Aeration P+* / *9( 7*(%,%+*%/) &/(77 $%) <9%9 (*9,()( /%( +)> / %*7 (+*%/) &/$*7 (7/0 /$*+7= /' *9( '(%+, (%( $)*%, &((*('%)( ,((,7 +( (+9(. T9%7 '+ 0( &(/'( <%*9%) *9( 7*(%,%( +)>/ %) + 7(&++*( 9+'0( / //'. Aeration Area E%*9( + 9+'0( / + //' %) <9%9 +(+*%/) /$7. T9( *('&(+*$( %) *9( +(+*%/) +(+ %7 (,(+*( +) /)*/,,( */ +77$( *9+* *9( +(+*%/) &/(77 %7 +(,(+*( +) (&(+*+0,(. A% %7 (%$,+*( %) *9( //' */ '+%)*+%) // 9(+* %7*%0$*%/) <%*9 + &/*%/) / *9( +% 7*%&&( / +) ,(+)7( <%*9 *9( &/,,$*%/) /)*/, (#$%&'()*. T9( 7*%&&%) / *9( +% ($(7 *9( +'/$)* / (( (*9,()( /%( (7%()* %) *9( //'7 *9$7 &(()*7 (/)*+'%)+*%/) / &/$* ,/+. AA'I A00(%+*%/) / *9( A77/%+*%/) / *9( A+)('()* / (%+, I)7*$'()*+*%/). AAI ()(+*(7 $%(,%)(7 <9%9 +( $7( %) *9( %)$7* / +,%+*%) '/)%*/%) +) &(/'%) /$*%)( EO 7*(%,%+*%/) &/(77(7. ANSI3AA'I3ISO ,,,6:#2BB< I)*()+*%/)+, O+)%+*%/) / S*+)+%+*%/) ISO= G$%+)( /$'()* <9%9 9+7 0(() +/&*( +) &$0,%79( 0 AI +) ANSI= */ +(77 +,%+*%/) +) /$*%)( /)*/, / (*9,()( /%( 7*(%,%+*%/). 5a"terio%ta%i%3Fn&i %ta%i% Te%t T(7* &(/'( */ (+,$+*( *9( &(7()( / '%/0%+, /<*9 %)9%0%*%) &/&(*%(7 / + 9(+,*9 +( &/$*. T9%7 *(7* +77$(7 *9+* +) (+*%/) / *9( /<*9 '(%$' <%*9 *9( %(()* '+*(%+,7 $7( %) *9( '+)$+*$( / *9( (%( <%,, )/* '+7 / &(()* /<*9 /' +) %+0,( /+)%7' ('+%)%) /) *9( (%( +*( 0(%) 7$0@(*( */ + 7*(%,%+*%/) &/(77. 5io)r(en P/&$,+*%/) / %+0,( '%//+)%7'7 /) + +< '+*(%+, /'&/)()* %)%79( &/$* +)>/ &++(. U),%( *9( +''+ %+%+*%/) &/(77 0%/0$() +*+ %7 )/* $*%,%( %) (*9,()( /%( 7*(%,%+*%/) */ (*('%)( *9( 7*(%,%+*%/) &/(77. I* %7 /,,(*( */ #$+)*% *9( +'/$)* / &/$* /)*+'%)+*%/) <9%9 %7 *9() /'&+( */ *9( &/&$,+*%/) / *9( 0%/,/%+, %)%+*/ $7( %) *9( EO 7*(%,%+*%/) &/(77. 5iolo&i"al In(i"ator I)/$,+*( +%( /)*+%)( <%*9%) %*7 &%'+ &+ (+ / $7( +) &/%%) + (%)( (7%7*+)( */ *9( 7&(%%( 7*(%,%+*%/) &/(77. Cali)ration C/'&+%7/) / + '(+7$('()* 77*(' / (%( / $))/<) +$+ */ + '(+7$('()* 77*(' / (%( / )/<) +$+ *+(+0,( */ )+*%/)+, 7*+)+7= */ (*(* /(,+*( (&/* / (,%'%)+*( 0 +@$7*'()* +) +%+*%/) /' *9( (#$%( &(/'+)( ,%'%*7 / *9( $)(%%( '(+7$('()* 77*(' / (%(. A,, %*%+, '(+7$%) (%(7 $*%,%( /) (*9,()( /%( 7*(%,%(7 <9%9 '+ %'&+* *9( #$+,%* / *9( &/(77 +( +,%0+*( */ *+(+0,( )+*%/)+,
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
/ %)*()+*%/)+, 7*+)+7. C$am)er E),/7( +(+ <9%9 /), +/''/+*(7 7$%%()* &/$* */ %,, *9( 7*(%,%(. EO 9+'0(7 +( /)7*$*( / 7*((, / 7*+%),(77 7*((, +) +( (7%)( */ <%*97*+) *9( (*('( &(77$(7 +) (,(+*( *('&(+*$(7 $*%,%( %) *9( EO 7*(%,%+*%/) &/(77. Commi%%ionin& O0*+%)%) +) /$'()*%) (%()( *9+* (#$%&'()* 9+7 0(() &/%( +) %)7*+,,( %) +/+)( <%*9 %*7 7&(%%+*%/) +) *9+* %* $)*%/)7 <%*9%) &((*('%)( ,%'%*7 <9() /&(+*( %) +/+)( <%*9 /&(+*%/)+, %)7*$*%/)7. A,, EO 7*(%,%+*%/) (#$%&'()* <9%9 /'&,%(7 <%*9 ANSI>AAI>ISO 11135 %7 /''%77%/)(. Con(itionin& T(+*'()* / &/$* <%*9%) *9( 7*(%,%+*%/) ,( 0$* &%/ */ 7*(%,+)* +'%77%/) */ +**+%) + &((*('%)( *('&(+*$( +) (,+*%( 9$'%%*. T9%7 &+* / *9( 7*(%,%+*%/) &/(77 '+ 0( +%( /$* (%*9( +* +*'/7&9(% &(77$( / $)( +$$' 7(( +,7/ &(/)%*%/)%)=. Criti"al Parameter% P++'(*(7 %()*%%( +7 0(%) (77()*%+, */ *9( 7*(%,%+*%/) &/(77 +) (#$%%) '/)%*/%). D8Vale T%'( (&(77( %) '%)$*(7= (#$%( */ +9%(( %)+*%+*%/) / 8; &(()* / + &/&$,+*%/) / + *(7* /+)%7' $)( 7*+*( (&/7$( /)%*%/)7. A,7/ ((()( +7 *9( D1; V+,$( / (%'+, ($*%/) +,$(. E@po%re Time T%'( / <9%9 *9( 7*(%,%( 9+'0( %7 '+%)*+%)( <%*9%) *9( 7&(%%( +)( / *('&(+*$( 7*(%,+)* /)()*+*%/) &(77$( +) (,+*%( 9$'%%*. A,7/ '+ 0( ((( */ +7 *9( *%'( / <9%9 + '(%+, (%( ,/+= %7 (&/7( +* *9( 7&(%%( 7*(%,%%) /)%*%/)7. Failre E()* %) <9%9 + /'&/)()* /(7 )/* &(/' /)( / '/( / %*7 (#$%( $)*%/)7 <%*9%) *9( 7&(%%( ,%'%*7 $)( 7&(%%( /)%*%/)7. Fl%$in& P/($( 0 <9%9 7*(%,+)* %7 ('/( /' *9( ,/+ +) 9+'0( 0 (%*9( '$,*%&,( +,*()+*( +'%77%/)7 / %,*(( +% / %)(* +7 +) (+$+*%/)7 / *9( 9+'0( / /)*%)$/$7 &+77+( / %,*(( +% / %)(* +7 *9/$9 *9( ,/+ +) 9+'0(. Ina"ti1ation L/77 / *9( +0%,%* / '%//+)%7'7 */ /< +)>/ '$,*%&, $)( 7&(%%( $,*$( /)%*%/)7. In(i"ator C/'0%)+*%/) / *9( %)%+*/ +()* +) %*7 7$07*+*( %) *9( /' %) <9%9 %* %7 %)*()( */ 0( $7(. Ino"late( Carrier C+%( /) <9%9 + (%)( )$'0( / *(7* /+)%7'7 9+( 0(() (&/7%*(. In%tallation 4ali!i"ation O0*+%)%) +) /$'()*%) (%()( *9+* (#$%&'()* 9+7 0(() &/%( +) %)7*+,,( %) +/+)( <%*9 %*7 7&(%%+*%/)7 +) *9+* %* $)*%/)7 <%*9%) &((*('%)( ,%'%*7 <9() /&(+*( %) +/+)( <%*9 *9( /&(+*%/)+, %)7*$*%/)7. 'an!a"trer N+*$+, / ,(+, &(7/) &++%) / 7*(%,%%) + '(%+, (%(. 'e(i"al De1i"e
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
A) %)7*$'()* +&&++*$7 +&&,%+)( '+*(%+, / /*9( +*%,( <9(*9( $7( +,/)( / %) /'0%)+*%/) %),$%) *9( 7/*<+( )((77+ / %*7 &/&( +&&,%+*%/) %)*()( 0 *9( '+)$+*$( */ 0( $7( / 9$'+) 0(%)7 / *9( &$&/7( /: M %+)/7%7 &(()*%/) '/)%*/%) *(+*'()* / +,,(%+*%/) / %7(+7( M %+)/7%7 '/)%*/%) *(+*'()* +,,(%+*%/) / / /'&()7+*%/) / +) %)@$ / 9+)%+& M %)(7*%+*%/) (&,+('()* / '/%%+*%/) / *9( +)+*/' / / + &97%/,/%+, &/(77 M /)*/, / /)(&*%/) +) <9%9 /(7 )/* +9%(( %*7 &%)%&+, %)*()( +*%/) %) / /) *9( 9$'+) 0/ 0 &9+'+/,/%+, %''$)/,/%+, / '(*+0/,% '(+)7 0$* <9%9 '+ 0( +77%7*( %) %*7 $)*%/) 0 7$9 '(+)7. 'i"ro)ial 5arrier A0%,%* / *9( &++%) 77*(' */ &(()* *9( %)(77 / '%//+)%7'7 $)( 7&(%%( /)%*%/)7. 'i"ro)iolo&i"al C$allen&e B%/,/%+, %)%+*/7 0%/,/%+,-%)%+*/ *(7* &+7 / %)/$,+*( &/$* *9+* /)*+%) )/<) &/&$,+*%/)7 / '%//+)%7'7 +) +) 0( $7( %) *(7*%) 7*(%,%+*%/) ,(7. O1er0ill Sterilization Pro"e%% P/(77 <9%9 %7 7$%%()* */ &/%( +* ,(+7* + 12-,/+%*9'% ($*%/) / 12 D %)+*%+*%/) / +) +&&/&%+*(, (7%7*+)* 0%/,/%+, %)%+*/ <%*9 +) (7*+0,%79( D +,$(. Pa"0a&e Inte&rity U)%'&+%( &97%+, /)%*%/) / + %)+, &++(. Parametri" Relea%e D(,+%) &/$* +7 7*(%,( 0+7( /) &97%+, +)>/ 9('%+, &/(77 +*+ +*9( *9+) /) *9( 0+7%7 / 7+'&,( *(7*%) / 0%/,/%+, %)%+*/ (7$,*7. Per!orman"e 4ali!i"ation O0*+%)%) +) /$'()*%) (%()( *9+* *9( (#$%&'()* +7 /''%77%/)( <%,, &/$( +(&*+0,( &/$* <9() /&(+*( +/%) */ *9( &/(77%) 7&(%%+*%/)7. Po%iti1e Sterility Te%t S*(%,%* *(7* 7+'&,(7 <9%9 (9%0%* (*(*+0,( '%/0%+, /<*9 +*( %)$0+*%/). Pre"on(itionin& T(+*'()* / &/$* &%/ */ *9( 7*(%,%+*%/) ,( %) + //' / 9+'0( */ +**+%) 7&(%%( ,%'%*7 / *('&(+*$( +) (,+*%( 9$'%%*. Pre"on(itionin& Area E%*9( + 9+'0( / + //' %) <9%9 &(/)%*%/)%) /$7. Pro"e%% Let$ality C+&+0%,%* / *9( 7*(%,%+*%/) &/(77 */ (7*/ '%//+)%7'7. Pro"e%% 4ali!i"ation O0*+%)%) +) /$'()*%) (%()( *9+* *9( 7*(%,%+*%/) &/(77 <%,, &/$( +(&*+0,( 9(+,*9 +( &/$*7. Pro("t G()(% *(' $7( */ (7%0( +< '+*(%+,7 %)*('(%+*( &/$*7 7$0+77('0,%(7 +) %)%79( '(%+, (%(7. Pro("t 4ali!i"ation O0*+%)%) +) /$'()*%) (%()( *9+* *9( 9(+,*9 +( &/$* <%,, 0( +(&*+0,( / %*7 %)*()( $7( +*( (&/7$( */ *9( 7*(%,%+*%/) &/(77. 4ali!i"ation
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TITLE:- VALIDATION PROTOCOL FOR ETHYLENE OXIDE STERILISATION PROCESS VALIDATION PROTOCOL NO: EFFECTIVE DATE:-
D/$'()*( (%()( *9+* +,, &(7%0( (7%) +) &(/'+)( (#$%('()*7 +( '(*. Re>ali!i"ation R(&(*%*%/) / &+* / +,, / *9( +,%+*%/) *(7* (#$%('()*7 / *9( &$&/7( / (/)%'%) &/(77 (,%+0%,%*. Sterilant %/0%%+, +()* %) *9( &97%+, /' %) <9%9 %* %7 +*%(. Sterile F(( /' %+0,( '%//+)%7'7. I) &+*%( )/ 7$9 +07/,$*( 7*+*('()* (+%) *9( +07()( / '%//+)%7'7 +) 0( &/() 7(( 7*(%,%+*%/)=. Sterility S*+*( / 0(%) (( /' %+0,( '%//+)%7'7. I) &+*%( )/ 7$9 +07/,$*( 7*+*('()* (+%) *9( +07()( / '%//+)%7'7 +) 0( &/() 7(( 7*(%,%+*%/)=. Sterility A%%ran"e Le1el *SAL+ P/0+0%,%* / + %+0,( '%//+)%7' 0(%) &(7()* /) + &/$* $)%* +*( 7*(%,%+*%/). SAL %7 )/'+,, (&(77( +* 1;-). Sterility Te%t T(7* &(/'( */ (*('%)( % %+0,( '%//+)%7'7 +( &(7()*. Sterilization V+,%+*( &/(77 $7( */ ()( + &/$* (( /' %+0,( '%//+)%7'7. I) + 7*(%,%+*%/) &/(77 *9( )+*$( / '%/0%+, (+*9 %7 (7%0( 0 +) (&/)()*%+, $)*%/). T9((/( *9( &(7()( / %+0,( '%//+)%7'7 /) +) %)%%$+, %*(' +) 0( (&(77( %) *('7 / &/0+0%,%*. K9%,( *9%7 &/0+0%,%* '+ 0( ($( */ + ( ,/< )$'0( %* +) )(( 0( ($( */ (/. T9( &/0+0%,%* +) 0( (&(77( +7 + 7*(%,%* +77$+)( ,((, SAL=. Sterilization Cy"le D(%)( 7(#$()( / /&(+*%/)+, 7*(&7 (7%)( */ +9%(( 7*(%,%+*%/) *9+* %7 +%( /$* %) + 7(+,( 9+'0(. S&(%%+,, / EO 7*(%,%+*%/) *9( *(+*'()* %) + 7(+,( 9+'0( /'&%7%) +% ('/+, /)%*%/)%) %)@(*%/) / 7*(%,+)* (&/7$( */ (*9,()( /%( +) ('/+, / (*9,()( /%(. Sterilization Loa( G//7 *9+* +( */ 0( / 9+( 0(() 7*(%,%( 7%'$,*+)(/$7, %) *9( 7+'( 7*(%,%+*%/) 9+'0(. Sterilization Pro"e%% A,, *(+*'()*7 <9%9 +( (#$%( */ +/'&,%79 7*(%,%+*%/) %),$%) &(/)%*%/)%) *9( 7*(%,%+*%/) ,( +) +(+*%/). Vali(ation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