Ethylene Oxide Sterilization Validation Protocol
Short Description
EO sterilization validation protocol...
Description
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('&(+*$(.................... (............................................... ...................................................... ................................................................... ........................................ 1; I()*%%+*%/) I()*%%+*%/) / *9( BI '(*9/. '(*9/...... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .......... .................12 ............12
+%)*+%)+( +%)*+%)+( / V+,%+*%/):....... V+,%+*%/):.................................. ...................................................... ................................................ ..................... ............. ........... ..14 14
R(#$+,%%+*%/)............. 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
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