{"id":2332,"date":"2024-11-26T10:16:36","date_gmt":"2024-11-26T02:16:36","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2332"},"modified":"2026-02-09T09:59:05","modified_gmt":"2026-02-09T01:59:05","slug":"terms-and-definitions-of-eto-gas-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2332","title":{"rendered":"Terms and definitions of eto gas sterilization"},"content":{"rendered":"\n
\"\"<\/figure><\/div>\n\n\n\n

Para sa mga layunin ng dokumentong ito, ang mga sumusunod na termino at kahulugan ay nalalapat sa isterilisasyon ng ethylene oxide<\/strong><\/p>\n\n\n\n

3.1 Pagpapahangin <\/a><\/strong><\/p>\n\n\n\n

\"\"<\/figure><\/div>\n\n\n\n

part of the eto gas sterilization process during which ethylene oxide and\/or its<\/p>\n\n\n\n

ang mga produkto ng reaksyon ay desorb mula sa medikal na aparato hanggang sa maabot ang mga paunang natukoy na antas<\/p>\n\n\n\n

Note 1 to entry: This can be performed within the sterilizer and\/or in a separate chamber or room.<\/p>\n\n\n\n

3.2 lugar ng aeration <\/strong><\/strong><\/p>\n\n\n\n

alinman sa isang silid o isang silid kung saan nangyayari ang aeration<\/p>\n\n\n\n

3.3 Bioburden <\/strong><\/strong><\/p>\n\n\n\n

population of viable microorganisms on or in product and\/or sterile barrier system<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.2]<\/p>\n\n\n\n

3.4 biological na tagapagpahiwatig <\/strong><\/strong><\/p>\n\n\n\n

sistema ng pagsubok na naglalaman ng mga mabubuhay na mikroorganismo na nagbibigay ng isang tiyak na pagtutol sa isang tinukoy na proseso ng sterilization ng gas eto<\/p>\n\n\n\n

3.5 Pag-calibrate <\/strong><\/strong><\/p>\n\n\n\n

hanay ng mga operasyon na nagtatatag, sa ilalim ng tinukoy na mga kundisyon, ang kaugnayan sa pagitan ng mga halaga ng isang dami na ipinahiwatig ng isang instrumento sa pagsukat o pagsukat<\/p>\n\n\n\n

sistema, o mga halagang kinakatawan ng isang materyal na sukat o isang sangguniang materyal, at ang mga katumbas na halaga na natanto ng mga pamantayan<\/p>\n\n\n\n

3.6 tagapagpahiwatig ng kemikal <\/strong><\/strong><\/p>\n\n\n\n

sistema ng pagsubok na nagpapakita ng pagbabago sa isa o higit pang paunang natukoy na mga variable ng proseso<\/p>\n\n\n\n

batay sa isang kemikal o pisikal na pagbabago na nagreresulta mula sa pagkakalantad sa isang proseso<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.6]<\/p>\n\n\n\n

3.7 Pagkondisyon <\/a><\/strong><\/p>\n\n\n\n

paggamot ng produkto sa loob ng eto gas sterilization cycle, ngunit bago ang ethylene<\/p>\n\n\n\n

oxide admission, upang makamit ang isang paunang natukoy na temperatura at relatibong halumigmig<\/p>\n\n\n\n

Tandaan 1 sa entry: Ang bahaging ito ng ethylene oxide sterilization cycle ay maaaring isagawa alinman sa atmospheric pressure o sa ilalim ng vacuum.<\/p>\n\n\n\n

Tandaan 2 sa entry: Tingnan ang 3.27, preconditioning<\/p>\n\n\n\n

3.8 <\/strong>D <\/em><\/strong><\/em><\/strong>halaga <\/strong><\/strong><\/p>\n\n\n\n

D<\/em>10 halaga <\/strong><\/strong><\/p>\n\n\n\n

oras o dosis na kinakailangan upang makamit ang inactivation ng 90 % ng isang populasyon ng pagsubok na microorganism sa ilalim ng mga nakasaad na kondisyon<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.11] ?<\/p>\n\n\n\n

Tandaan 1 sa entry: Para sa mga layunin ng International Standard na ito, ang D <\/em>ang halaga ay ang oras ng pagkakalantad na kinakailangan upang makamit ang 90 % na hindi aktibo ng populasyon ng organismo ng pagsubok.<\/p>\n\n\n\n

3.9 Pag-unlad <\/strong><\/strong><\/p>\n\n\n\n

gawa ng elaborasyon ng isang detalye<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.13]<\/p>\n\n\n\n

3.10 punto ng hamog <\/strong><\/strong><\/p>\n\n\n\n

Ang temperatura kung saan ang saturation water vapor pressure ay katumbas ng<\/p>\n\n\n\n

bahagyang presyon ng singaw ng tubig sa atmospera<\/p>\n\n\n\n

Tandaan 1 sa entry: Ang anumang paglamig ng atmospera sa ibaba ng dew point ay magbubunga ng water condensation.<\/p>\n\n\n\n

3.11 Magtatag <\/strong><\/strong><\/p>\n\n\n\n

matukoy sa pamamagitan ng teoretikal na pagsusuri at kumpirmahin sa pamamagitan ng eksperimento<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.17]<\/p>\n\n\n\n

9ISO 11135-2014<\/p>\n\n\n\n

3.12 oras ng pag-iniksyon ng ethylene oxide (EO).<\/strong> <\/a><\/p>\n\n\n\n

tagal ng yugto na nagsisimula sa unang pagpapakilala ng EO (halo) sa silid hanggang sa matapos ang iniksyon na iyon<\/p>\n\n\n\n

3.13 oras ng pagkakalantad <\/strong><\/strong><\/p>\n\n\n\n

panahon kung saan ang mga parameter ng proseso ay pinananatili sa loob ng kanilang mga tinukoy na tolerance<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.18]<\/p>\n\n\n\n

Tandaan 1 sa entry: Para sa layunin ng pagkalkula ng cycle lethality, ito ay ang panahon ng ethylene oxide sterilization sa pagitan ng pagtatapos ng EO injection at simula ng EO removal.<\/p>\n\n\n\n

3.14 Kasalanan <\/strong><\/strong><\/p>\n\n\n\n

one or more of the process parameters lying outside of its\/their specified<\/p>\n\n\n\n

pagpapaubaya (mga)<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.19]<\/p>\n\n\n\n

3.15 Pag-flush <\/strong><\/strong><\/p>\n\n\n\n

pamamaraan kung saan ang ethylene oxide ay tinanggal mula sa load at chamber<\/p>\n\n\n\n

sa pamamagitan ng alinman sa maramihang kahaliling pagpasok ng na-filter na hangin, inert gas o singaw at paglisan ng silid o tuluy-tuloy na pagdaan ng na-filter na hangin, inert 10ISO 11135-2014 na gas o singaw sa pamamagitan ng load at chamber<\/p>\n\n\n\n

3.16 fractional cycle <\/strong><\/strong><\/p>\n\n\n\n

isang cycle kung saan ang oras ng pagkakalantad sa EO gas ay nababawasan kumpara doon<\/p>\n\n\n\n

tinukoy sa proseso ng isterilisasyon ng ethylene oxide<\/p>\n\n\n\n

3.17 kalahating ikot <\/strong><\/strong><\/p>\n\n\n\n

isang cycle kung saan ang oras ng pagkakalantad sa EO gas ay nababawasan ng 50 % kumpara sa tinukoy sa proseso ng isterilisasyon ng ethylene oxide<\/p>\n\n\n\n

3.18 pasilidad ng pangangalagang pangkalusugan <\/strong><\/strong><\/p>\n\n\n\n

pamahalaan at pribadong organisasyon at institusyon na nakatuon sa<\/p>\n\n\n\n

pagsulong at pagpapanatili ng kalusugan, at ang pag-iwas at paggamot ng<\/p>\n\n\n\n

mga sakit at pinsala<\/p>\n\n\n\n

HALIMBAWA Ang pasilidad ng pangangalagang pangkalusugan ay maaaring isang ospital, nursing home, pasilidad ng pinalawig na pangangalaga, free-standing surgical center, klinika, opisinang medikal, o opisina ng ngipin.<\/p>\n\n\n\n

3.19 produkto ng pangangalagang pangkalusugan <\/strong><\/strong><\/p>\n\n\n\n

(mga) medikal na kagamitan, kabilang ang sa vitro <\/em>(mga) diagnostic na medikal na device, o (mga) produktong panggamot, kabilang ang (mga) biopharmaceutical<\/p>\n\n\n\n

11 ISO 11135-2014<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.20]<\/p>\n\n\n\n

3.20 kwalipikasyon sa pag-install <\/a><\/strong><\/p>\n\n\n\n

proseso ng pagkuha at pagdodokumento ng ebidensya na ang kagamitan ay naibigay na<\/p>\n\n\n\n

at naka-install alinsunod sa detalye nito<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.22]<\/p>\n\n\n\n

3.21 medikal na aparato <\/strong><\/strong><\/p>\n\n\n\n

anumang instrumento, apparatus, implement, makina, appliance, implant, sa vitro <\/em>reagent o calibrator, software, materyal o kaugnay na artikulo, na nilayon ng tagagawa na gamitin, nang mag-isa o pinagsama, para sa mga tao para sa isa o higit pa sa (mga) partikular na layunin ng<\/p>\n\n\n\n

\u2014 diagnosis, prevention, monitoring, treatment or alleviation of disease,<\/p>\n\n\n\n

\u2014 diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,<\/p>\n\n\n\n

\u2014 investigation, replacement or modification or support of the anatomy or of a physiological process,<\/p>\n\n\n\n

\u2014 control of conception,<\/p>\n\n\n\n

\u2014 disinfection of medical devices,<\/p>\n\n\n\n

\u2014 providing information for medical purposes by means of sa vitro <\/em>pagsusuri ng mga specimen na nagmula sa katawan ng tao, at hindi nakakamit ang pangunahing nilalayon nitong pagkilos sa o sa katawan ng tao sa pamamagitan ng pharmacological, immunological o metabolic na paraan, ngunit maaaring matulungan sa paggana nito sa pamamagitan ng mga paraan<\/p>\n\n\n\n

[SOURCE: ISO 13485:2003, kahulugan 3.7]<\/p>\n\n\n\n

?<\/p>\n\n\n\n

3.22 mikroorganismo <\/strong><\/strong><\/p>\n\n\n\n

nilalang na may mikroskopikong laki, sumasaklaw sa bakterya, fungi, protozoa at mga virus<\/p>\n\n\n\n

Tandaan 1 sa entry: Ang isang partikular na pamantayan ay maaaring hindi nangangailangan ng pagpapakita ng<\/p>\n\n\n\n

pagiging epektibo ng proseso ng eto gas sterilization sa pag-inactivate ng lahat ng uri ng<\/p>\n\n\n\n

microorganisms, identified in the definition above, for validation and\/or<\/p>\n\n\n\n

nakagawiang kontrol sa proseso ng eto gas sterilization.<\/p>\n\n\n\n

3.23 kwalipikasyon sa pagpapatakbo <\/a><\/strong><\/p>\n\n\n\n

proseso ng pagkuha at pagdodokumento ng ebidensya na naka-install na kagamitan<\/p>\n\n\n\n

gumagana sa loob ng paunang natukoy na mga limitasyon kapag ginamit alinsunod sa nito<\/p>\n\n\n\n

mga pamamaraan sa pagpapatakbo<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.27]<\/p>\n\n\n\n

3.24 overkill na diskarte<\/strong><\/strong><\/p>\n\n\n\n

diskarte gamit ang eto gas sterilization na proseso na naghahatid ng minimum na 12 Spore Log<\/p>\n\n\n\n

Reduction (SLR) sa isang biological indicator na may resistensya na katumbas o mas malaki kaysa sa bioburden ng produkto<\/p>\n\n\n\n

3.25 parametric na paglabas <\/strong><\/strong><\/p>\n\n\n\n

deklarasyon na ang produkto ay sterile, batay sa mga talaan na nagpapakita na ang mga parameter ng proseso ay naihatid sa loob ng mga tinukoy na tolerance<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.29]<\/p>\n\n\n\n

Tandaan 1 sa entry: Ang paraan ng paglabas ng proseso ay hindi kasama ang paggamit ng mga biological indicator.<\/p>\n\n\n\n

3.26 kwalipikasyon sa pagganap <\/a><\/strong><\/p>\n\n\n\n

proseso ng pagkuha at pagdodokumento ng ebidensya na ang kagamitan, bilang naka-install at pinapatakbo alinsunod sa mga pamamaraan ng pagpapatakbo, ay patuloy na gumagana alinsunod sa paunang natukoy na pamantayan at sa gayon ay nagbubunga ng produkto na nakakatugon sa detalye nito<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.30]<\/p>\n\n\n\n

3.27 Preconditioning <\/a><\/strong><\/p>\n\n\n\n

paggamot ng produkto, bago ang eto gas sterilization cycle, sa isang silid o silid upang makamit ang mga tinukoy na kondisyon para sa temperatura at relatibong halumigmig<\/p>\n\n\n\n

3.28 process challenge device <\/strong><\/strong><\/p>\n\n\n\n

item na idinisenyo upang bumuo ng isang tinukoy na pagtutol sa proseso ng sterilization ng aeto gas at ginamit upang masuri ang pagganap ng proseso<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.33]<\/p>\n\n\n\n

Tandaan 1 sa entry: Para sa layunin ng International Standard na ito, ang isang PCD ay maaaring<\/p>\n\n\n\n

maging produkto, kunwa ng produkto o iba pang device na direktang inoculate o<\/p>\n\n\n\n

hindi direkta. Tingnan ang 7.1.6 at D.7.1.6.<\/p>\n\n\n\n

Tandaan 2 sa entry: Sa International Standard na ito, isang pagkakaiba ang ginawa sa pagitan ng isang panloob na PCD at isang panlabas na PCD. Ang isang panloob na PCD ay ginagamit upang ipakita na ang kinakailangang produkto SAL ay nakakamit. Ang isang PCD na matatagpuan sa loob ng mga limitasyon ng case ng produkto o shipper ng produkto ay isang panloob na PCD, samantalang ang isang PCD na matatagpuan sa pagitan ng mga case ng shipper o sa mga panlabas na ibabaw ng load ay isang panlabas na PCD. Ang panlabas na PCD ay isang bagay na idinisenyo upang magamit para sa microbiological<\/p>\n\n\n\n

pagsubaybay sa mga nakagawiang siklo ng produksyon.<\/p>\n\n\n\n

3.29 na parameter ng proseso <\/strong><\/strong><\/p>\n\n\n\n

tinukoy na halaga para sa isang variable ng proseso<\/p>\n\n\n\n

Tandaan 1 sa entry: Kasama sa detalye para sa proseso ng eto gas sterilization ang<\/p>\n\n\n\n

mga parameter ng proseso at ang kanilang mga tolerance.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.34]<\/p>\n\n\n\n

3.30 variable ng proseso <\/strong><\/strong><\/p>\n\n\n\n

kondisyon sa loob ng proseso ng isterilisasyon ng ethylene oxide, mga pagbabago kung saan binabago ang pagiging epektibo ng microbicidal<\/p>\n\n\n\n

HALIMBAWA? Oras, temperatura, presyon, konsentrasyon, halumigmig, haba ng daluyong.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.35]<\/p>\n\n\n\n

3.31 kategorya ng pagproseso <\/strong><\/strong><\/p>\n\n\n\n

koleksyon ng iba't ibang produkto o pamilya ng produkto na maaaring isterilisado<\/p>\n\n\n\n

magkasama<\/p>\n\n\n\n

Tandaan 1 sa pagpasok: Ang lahat ng mga produkto sa loob ng kategorya ay natukoy na magpapakita ng katumbas o mas maliit na hamon sa proseso ng isterilisasyon ng ethylene oxide kaysa sa device challenge sa proseso para sa pangkat na iyon.<\/p>\n\n\n\n

3.32 Produkto <\/strong><\/strong><\/p>\n\n\n\n

resulta ng isang proseso<\/p>\n\n\n\n

[SOURCE: ISO 9000:2005, kahulugan 3.4.2]<\/p>\n\n\n\n

Tandaan 1 sa entry: Para sa mga layunin ng ethylene oxide sterilization standards, ang produkto ay<\/p>\n\n\n\n

nasasalat at maaaring (mga) hilaw na materyal, (mga) intermediate, (mga) sub-assembly at<\/p>\n\n\n\n

mga produkto ng pangangalagang pangkalusugan.<\/p>\n\n\n\n

3.33 pamilya ng produkto <\/strong><\/strong><\/p>\n\n\n\n

pangkat ng mga produkto na nagtataglay ng mga katangian na nagpapahintulot sa kanila na ma-sterilize<\/p>\n\n\n\n

gamit ang tinukoy na mga kondisyon ng proseso<\/p>\n\n\n\n

3.34 dami ng pagkarga ng produkto<\/strong><\/strong><\/p>\n\n\n\n

tinukoy na espasyo sa loob ng magagamit na dami ng silid na inookupahan ng produkto<\/p>\n\n\n\n

3.35 kinikilalang koleksyon ng kultura <\/strong><\/strong><\/p>\n\n\n\n

awtoridad sa deposito sa ilalim ng Budapest Treaty noong Ang International<\/em><\/p>\n\n\n\n

Pagkilala sa Deposito ng<\/em><\/p>\n\n\n\n

Mga Mikroorganismo para sa Mga Layunin ng Patent at Regulasyon<\/em><\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.38]<\/p>\n\n\n\n

3.36 reference microorganism <\/strong><\/p>\n\n\n\n

microbial strain na nakuha mula sa isang kinikilalang koleksyon ng kultura<\/p>\n\n\n\n

3.37 Muling Kwalipikasyon <\/strong><\/p>\n\n\n\n

pag-uulit ng bahagi ng pagpapatunay para sa layunin ng pagkumpirma ng patuloy na katanggap-tanggap ng isang tinukoy na proseso<\/p>\n\n\n\n

3.38 magagamit muli na medikal na aparato <\/strong><\/strong><\/p>\n\n\n\n

medikal na aparato na itinalaga o inilaan ng tagagawa bilang angkop para sa<\/p>\n\n\n\n

muling pagpoproseso at muling paggamit<\/p>\n\n\n\n

Tandaan 1 sa entry: Ito ay hindi isang medikal na aparato na itinalaga o nilayon<\/p>\n\n\n\n

ng tagagawa para sa solong paggamit lamang.<\/p>\n\n\n\n

3.39 Mga Serbisyo <\/strong><\/strong><\/p>\n\n\n\n

mga supply mula sa isang panlabas na mapagkukunan, na kailangan para sa tamang paggana ng kagamitan<\/p>\n\n\n\n

HALIMBAWA Elektrisidad, tubig, compressed air, drainage.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.41]<\/p>\n\n\n\n

3.40 pang-isahang gamit na medikal na aparato <\/strong><\/p>\n\n\n\n

medikal na aparato na itinalaga o inilaan ng tagagawa para sa isang beses na paggamit lamang<\/p>\n\n\n\n

3.41 Tukuyin <\/strong><\/strong><\/p>\n\n\n\n

itakda nang detalyado sa loob ng isang naaprubahang dokumento<\/p>\n\n\n\n

3.42 Spore-log-reduction <\/strong>log ng paunang populasyon ng spore, N<\/em>0, binawasan ang log ng huling populasyon, N<\/em>u<\/p>\n\n\n\n

[SOURCE: ISO 14161:2009, kahulugan 3.19]<\/p>\n\n\n\n

Tandaan 1 sa entry: Inilalarawan ang pagbawas sa bilang ng mga spores sa a<\/p>\n\n\n\n

biological indicator o inoculated item na ginawa ng pagkakalantad sa tinukoy<\/p>\n\n\n\n

kundisyon.<\/p>\n\n\n\n

Para sa Direct Enumeration:<\/p>\n\n\n\n

SLR = log N<\/em>0 log ? N<\/em>u<\/p>\n\n\n\n

saan<\/p>\n\n\n\n

N<\/em>0 ay ang paunang populasyon;<\/p>\n\n\n\n

N<\/em>u ang huling populasyon.<\/p>\n\n\n\n

Para sa Fraction Negative:<\/p>\n\n\n\n

SLR = log N<\/em>0 \u2013 log [ln (q<\/em>\/n<\/em>)]<\/p>\n\n\n\n

saan<\/p>\n\n\n\n

N<\/em>0 ay ang paunang populasyon;<\/p>\n\n\n\n

q <\/em>ay ang bilang ng mga kopyang sample na nasubok;<\/p>\n\n\n\n

n <\/em>ay ang bilang ng mga sample na negatibo para sa paglago.<\/p>\n\n\n\n

Kung walang nakaligtas, hindi makalkula ang totoong SLR. Ang SLR ay maaaring<\/p>\n\n\n\n

reported as \u201cgreater than\u201d log N<\/em>0 kung gagamitin ang isang nabubuhay na organismo.<\/p>\n\n\n\n

3.43 Steril <\/strong><\/strong><\/p>\n\n\n\n

libre mula sa mabubuhay na mga mikroorganismo<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.43]<\/p>\n\n\n\n

3.44 sterile barrier system<\/strong><\/strong><\/p>\n\n\n\n

minimum na pakete na pumipigil sa pagpasok ng mga mikroorganismo at nagbibigay-daan sa aseptiko<\/p>\n\n\n\n

pagtatanghal ng produkto sa punto ng paggamit<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.44]<\/p>\n\n\n\n

3.45 Sterility<\/strong><\/p>\n\n\n\n

estado ng pagiging malaya mula sa mga mabubuhay na mikroorganismo<\/p>\n\n\n\n

Tandaan 1 sa entry: Sa pagsasagawa, walang ganoong ganap na pahayag tungkol sa kawalan ng mga microorganism ang maaaring mapatunayan.<\/p>\n\n\n\n

Tandaan 2 sa entry: Tingnan ang 3.47, isterilisasyon.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.45]<\/p>\n\n\n\n

3.46 antas ng kasiguruhan ng sterility <\/strong><\/strong><\/p>\n\n\n\n

posibilidad ng isang mabubuhay na microorganism na maganap sa isang item pagkatapos<\/p>\n\n\n\n

isterilisasyon<\/p>\n\n\n\n

Tandaan 1 sa entry: Ang terminong SAL ay tumatagal ng isang quantitative value, sa pangkalahatan ay 10-6 o 10-3. Kapag inilalapat ang quantitative value na ito sa assurance ng sterility, ang SAL na 10-6 ay may mas mababang halaga ngunit nagbibigay ng mas malaking assurance ng sterility kaysa sa SAL na 10-3.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.46]<\/p>\n\n\n\n

3.47 Isterilisasyon <\/a><\/strong><\/p>\n\n\n\n

validated na proseso na ginamit upang gawing libre ang produkto mula sa mga mabubuhay na mikroorganismo<\/p>\n\n\n\n

Tandaan 1 sa entry: Sa isang proseso ng isterilisasyon, ang likas na katangian ng microbial<\/p>\n\n\n\n

Ang inactivation ay exponential at sa gayon ang kaligtasan ng isang microorganism sa isang indibidwal na item ay maaaring ipahayag sa mga tuntunin ng posibilidad. Habang ito<\/p>\n\n\n\n

maaaring bawasan ang probabilidad sa napakababang bilang, hindi ito kailanman mababawasan sa zero. ISO 11135-2014<\/p>\n\n\n\n

Tandaan 2 sa entry: Tingnan ang 3.46, antas ng kasiguruhan ng sterility.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.47]<\/p>\n\n\n\n

3.48 ikot ng isterilisasyon <\/a><\/strong><\/p>\n\n\n\n

treatment in a sealed chamber, which includes air removal, conditioning (if used), injection of ethylene oxide, inert gas (if used), exposure to ethylene oxide, removal of ethylene oxide and flushing (if used), and air\/inert gas admission<\/p>\n\n\n\n

3.49 pagkarga ng isterilisasyon <\/strong><\/strong><\/p>\n\n\n\n

produkto na, o na, isterilisado nang magkasama gamit ang isang ibinigay<\/p>\n\n\n\n

proseso ng isterilisasyon<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.48]<\/p>\n\n\n\n

3.50 proseso ng isterilisasyon <\/a><\/strong><\/p>\n\n\n\n

serye ng mga aksyon o operasyon na kailangan upang makamit ang mga tinukoy na kinakailangan para sa sterility<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.49]<\/p>\n\n\n\n

Tandaan 1 sa entry: Kasama sa seryeng ito ng mga aksyon o pagpapatakbo ang preconditioning<\/p>\n\n\n\n

(kung kinakailangan), pagkakalantad sa ethylene oxide sa ilalim ng tinukoy na mga kondisyon at anumang kinakailangang post-treatment na kinakailangan para sa pag-alis ng ethylene oxide at mga by-product nito. Hindi kasama dito ang anumang paglilinis, pagdidisimpekta o mga pagpapatakbo ng packaging na nauuna sa proseso ng isterilisasyon.<\/p>\n\n\n\n

3.51 espesyalista sa isterilisasyon <\/strong><\/strong><\/p>\n\n\n\n

taong may teknikal na kaalaman sa teknolohiya ng isterilisasyon na ginagamit at ang mga epekto nito sa mga materyales at mikroorganismo<\/p>\n\n\n\n

3.52 sterilizing agent <\/strong><\/strong><\/p>\n\n\n\n

paglalagay ng mga entity na may sapat na aktibidad ng microbicidal upang makamit ang sterility sa ilalim ng tinukoy na mga kondisyon<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.50]<\/p>\n\n\n\n

3.53 survivor curve <\/strong><\/p>\n\n\n\n

graphical na representasyon ng hindi aktibo ng isang populasyon ng mga microorganism na may pagtaas ng pagkakalantad sa isang microbicidal agent sa ilalim ng nakasaad na mga kondisyon<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.51]<\/p>\n\n\n\n

3.54 pagsubok para sa sterility <\/strong><\/strong><\/p>\n\n\n\n

teknikal na operasyong tinukoy sa isang Pharmacopoeia na ginawa sa produkto kasunod ng pagkakalantad sa isang proseso ng isterilisasyon<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.53]<\/p>\n\n\n\n

3.55 pagsubok ng sterility <\/strong><\/strong><\/p>\n\n\n\n

teknikal na operasyong isinagawa bilang bahagi ng pagpapaunlad, pagpapatunay, o<\/p>\n\n\n\n

muling kwalipikasyon upang matukoy ang pagkakaroon o kawalan ng mga mabubuhay na mikroorganismo sa produkto o mga bahagi nito<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.54]<\/p>\n\n\n\n

3.56 nagagamit na dami ng silid <\/strong><\/strong><\/p>\n\n\n\n

tinukoy na espasyo sa loob ng silid ng sterilizer, na hindi pinaghihigpitan ng mga nakapirming o mobile na bahagi at magagamit upang tanggapin ang pagkarga ng isterilisasyon<\/p>\n\n\n\n

Tandaan 1 sa entry: Ang volume na pinapayagan para sa sirkulasyon ng gas sa paligid ng load sa loob<\/p>\n\n\n\n

ang silid ay hindi kasama bilang magagamit na espasyo.<\/p>\n\n\n\n

3.57 Pagpapatunay <\/a><\/strong><\/p>\n\n\n\n

dokumentadong pamamaraan para sa pagkuha, pag-record at pagbibigay-kahulugan sa mga resulta na kinakailangan upang matukoy na ang isang proseso ay patuloy na magbubunga ng produkto na sumusunod sa mga paunang natukoy na mga detalye<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.55]<\/p>\n\n\n\n

3.58 birhen na materyal <\/strong><\/p>\n\n\n\n

materyal na hindi pa nagamit dati, o sumailalim sa pagproseso maliban sa orihinal nitong produksyon<\/p>\n\n\n\n

KUNG NAIS MONG MALAMAN ANG HIGIT PA Tungkol sa Ethylene Oxide Sterilization<\/h2>\n\n\n\n

Telepono:+8619975258603<\/a><\/p>\n\n\n\n

Email:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

Lokal na Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n

Website:hzbocon.com<\/a> zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization 3.1 Aeration part of 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