{"id":2076,"date":"2024-10-31T11:28:17","date_gmt":"2024-10-31T03:28:17","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2076"},"modified":"2025-12-05T11:11:54","modified_gmt":"2025-12-05T03:11:54","slug":"ethylene-oxide-sterilization-chamber","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2076","title":{"rendered":"PQ in Ethylene oxide sterilization chamber"},"content":{"rendered":"\n
\"Ethylene<\/figure><\/div>\n\n\n\n

PQ нь этилен ислийн ариутгалын камерыг ашиглан этилен ислийн ариутгах төхөөрөмж нь урьдчилан тогтоосон хүлээн авах шалгуурын дагуу тогтмол ажиллаж, үйл явц нь ариутгасан, заасан шаардлагад нийцсэн бүтээгдэхүүн гаргадгийг харуулах баталгаажуулалтын үе шат юм.<\/p>\n\n\n\n

PQ should be carried out for each new process and\/or product to be validated to demonstrate that the process complies with identified acceptance criteria and is capable of delivering the required SAL to the product.PQ consists of both microbiological and physical performance qualifications and is performed in the Ethylene oxide sterilization equipment used to sterilize the product.<\/p>\n\n\n\n

During PQ process, the package of the product and loading mode of the product\u00a0should be specified;\u00a0Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.<\/p>\n\n\n\n

During PQ process, the package of the product and loading mode of the product\u00a0should be specified;\u00a0Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.<\/p>\n\n\n\n

Ерөнхийдөө MPQ болон PPQ нь нэгэн зэрэг хийгдэнэ.Хэрэв PPQ-ийг дор хаяж гурван MPQ гүйлттэй зэрэгцүүлэн гүйцэтгэсэн бол хамгийн багадаа нэг нэмэлт PPQ гүйлтийг бүрэн мөчлөгийн процессын тодорхойлолтыг ашиглан гүйцэтгэнэ. Физик PQ (PPQ) нь санал болгож буй ердийн үйл явцын тодорхойлолтын хугацаанд ачааллын туршид заасан хүлээн авах шалгуурыг хангаж байгааг харуулах ёстой.<\/p>\n\n\n\n

Өмнө нь баталгаажуулсан бүтээгдэхүүн, сав баглаа боодол, ачааллын тохируулгатай тэнцэх этилений ислийн ариутгах камер, процессыг баримтжуулаагүй бол шинэ эсвэл өөрчилсөн бүтээгдэхүүн, сав баглаа боодол, ачааллын тохиргоо, этилен ислийн ариутгах камер, процессын параметрүүдийг нэвтрүүлэхэд PQ хийнэ.<\/p>\n\n\n\n

PQ баталгаажуулалт Этилен ислийн ариутгалын камерын процесс<\/h2>\n\n\n\n

PQ баталгаажуулалтын үйл явц нь ерөнхийдөө дараах байдалтай байна: эхлээд бутархай цикл хийж, дараа нь бүтээгдэхүүний ариутгалын байдлыг шалгана.
бутархай
\u00a0cycle sterilization; compare the EO resistance relationship between IPCD, EPCD and representative products (the expected result is EPCD > IPCD > Product,); Refer to ISO-11737-2 for the test requirements involved in the fractional cycle.<\/p>\n\n\n\n

Ариутгах үйл явц, ариутгалын үр нөлөөг давтах чадварыг батлахын тулд хагас мөчлөгийг гүйцэтгэх; Хэрэв хэт халах аргыг хэрэглэвэл хагас мөчлөгийн үед эерэг IPCD байх ёсгүй. Хэрэв IPCD-ээс илүү эсэргүүцэл үзүүлсэн бол хагас мөчлөгийн эерэг EPCD-ийг хүлээн зөвшөөрнө.
\u201c
хамгийн муу сорилт
\u201d
ердийн боловсруулалтад зориулагдсан.<\/p>\n\n\n\n

Ариутгалын ердийн параметрүүдийг ихэвчлэн бүтэн мөчлөгийн параметрүүдээр тодорхойлдог тул зохих агааржуулалтын хугацааг тодорхойлохын тулд үлдэгдэл сорилтыг ерөнхийдөө бүтэн мөчлөгийн туршид хийдэг. Ариутгах үйл явцын үр нөлөө нь фракц болон хагас мөчлөгт батлагдсан тул ариутгалын үр нөлөөг EPCD-ээр баталгаажуулж болно.<\/p>\n\n\n\n

Хэрэв эдгээр гүйлтийн аль нэгэнд ариутгал эсвэл бүтээгдэхүүний үйл ажиллагааны шаардлага хангагдаагүй бол нэмэлт мэргэшлийн гүйлт хийх шаардлагатай эсэхийг тогтоохын тулд судалгаа явуулна. Хэрэв процессын параметрүүдийг тогтоосон хязгаарт байлгах боломжгүй бол мөрдөн байцаалтын ажиллагаа явуулна. Хэрэв өөрчлөлт оруулсан бол нэмэлт гүйлт хийх шаардлагатай болно.<\/p>\n\n\n\n

Этилен ислийн ариутгалын камерын үйл явц дахь жилийн PQ<\/h2>\n\n\n\n

Review of PQ should assessment that the sterilization process remains valid for the designated product.Reduced MPQ\/PPQ can be necessary in certain situations, e.g. to verify continued appropriateness of the resistance of the internal PCD in the product load to the resistance of the product bioburden, or, after a defined interval, to provide evidence that there has been no inadvertent change since the previous requalification study. This would typically include, minimally,one fractional or half cycle exposure including load temperature and humidity measurements. Fractional cycles in a developmental chamber can also be used to support a requalification program, but requalification of the production chamber should be performed in the production chamber.<\/p>\n\n\n\n

Тэнцвэртэй байдлын үнэлгээ<\/h2>\n\n\n\n

1.Процессын тэнцэл?Этилен ислийн ариутгах төхөөрөмж нь ижил процессын параметрүүдийг хангадаг. IQ<\/a> болон OQ<\/a>, аль аль нь мэргэшсэн байна.<\/p>\n\n\n\n

2. анхны камертай ижил аргаар, эсвэл ачааллын температур, чийгшлийн жигд байдлыг харуулахын тулд микробиологийн үхэл болон PPQ-ийн шаардлагатай түвшинг харуулсан бууруулсан MPQ ашиглах ба үйлдвэрлэлийн камерын хяналт. Энэхүү бууруулсан мэргэшлийн үндэслэлийг тэмдэглэж, баримтжуулна.<\/p>\n\n\n\n

3. Бүтээгдэхүүний болон ачааллын шинж чанарт газарзүйн өөр өөр байршлын нөлөөллийг тодорхойлно.<\/p>\n\n\n\n

4. Процессын эквивалент гэдэг нь ижил баталгаажсан ариутгалын процессыг хоёр буюу түүнээс дээш ширхэг буюу иж бүрдэл этилен оксидын ариутгах төхөөрөмжөөр дамжуулж байгааг нотлох арга юм. Энэ нь тоног төхөөрөмж нь бие махбодийн хувьд ижил байхыг шаарддаггүй. Тоног төхөөрөмжийн нийлүүлсэн параметрүүд нь статистикийн хувьд ижил биш байсан ч, хэрэв тэдгээр нь бүгд тодорхойлогдсон, баталгаажуулсан процессын хязгаарт үйл явцыг явуулах чадвартай бол нийлүүлсэн процессууд ижил байх болно.<\/p>\n\n\n\n

5. Олон тооны тоног төхөөрөмжийн процессын тэнцэл нь тухайн процессын шалгуурыг хангахад шаардагдах туршилтын хэмжээг багасгах зорилготой юм. Ариутгах процессыг нэг камерт баталгаажуулах ёстой. Үлдсэн тоног төхөөрөмж нь суурилуулах чадвар (IQ) болон ашиглалтын чадвар (OQ) -д хамрагдсан тохиолдолд PQ буурсан байж болно (9.2 ба 9.3-ыг үзнэ үү). Хэд хэдэн тоног төхөөрөмжийн дахин мэргэшлийг бууруулахын тулд эквивалентыг ашиглаж болно. Ариутгалын процессыг явуулахад ашигладаг тоног төхөөрөмж нь ихэвчлэн камер эсвэл өрөө, туслах хяналтын системээс бүрддэг. Ариутгалын технологийн тоног төхөөрөмж нь тухайн боловсруулах байгууламжийн дотор эсвэл хэд хэдэн байгууламжийн дунд байрлаж болно. Энэхүү тоног төхөөрөмжийг ижил процессын нөхцөлийг хангахын тулд бие даан ашиглаж болох ба яг ижил загвартай эсвэл туслах тоног төхөөрөмжийн хэмжээ, хэмжээгээр ялгаатай байж болно.<\/p>\n\n\n\n

6. Олон тооны тоног төхөөрөмжийн процессын тэнцэл нь тухайн процессын шалгуурыг хангахад шаардагдах туршилтын хэмжээг багасгах зорилготой юм. Ариутгах процессыг нэг камерт баталгаажуулах ёстой. Үлдсэн тоног төхөөрөмж нь суурилуулах чадвар (IQ) болон ашиглалтын чадвар (OQ) -д хамрагдсан тохиолдолд PQ буурсан байж болно (9.2 ба 9.3-ыг үзнэ үү). Хэд хэдэн тоног төхөөрөмжийн дахин мэргэшлийг бууруулахын тулд эквивалентыг ашиглаж болно. Ариутгалын процессыг явуулахад ашигладаг тоног төхөөрөмж нь ихэвчлэн камер эсвэл өрөө, туслах хяналтын системээс бүрддэг. Ариутгалын технологийн тоног төхөөрөмж нь тухайн боловсруулах байгууламжийн дотор эсвэл хэд хэдэн байгууламжийн дунд байрлаж болно. Энэхүү тоног төхөөрөмжийг ижил процессын нөхцөлийг хангахын тулд бие даан ашиглаж болох ба яг ижил загвартай эсвэл туслах тоног төхөөрөмжийн хэмжээ, хэмжээгээр ялгаатай байж болно.<\/p>\n\n\n\n

ТА ИЛҮҮ МЭДЭХИЙГ ХҮСВЭЛ <\/h2>\n\n\n\n

Утас:+8619975258603<\/a><\/p>\n\n\n\n

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

Орон нутгийн сайт: Хятад, Жэжян муж, Ханжоу хот, Шиаша дүүрэг, Кайтон Жүншин, 1202 тоот<\/p>\n\n\n\n

Вэбсайт:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

PQ нь этилен ислийн ариутгалын камерыг ашиглан этилен ислийн ариутгах төхөөрөмж нь урьдчилан тогтоосон хүлээн авах шалгуурын дагуу тогтмол ажиллаж, үйл явц нь ариутгасан, заасан шаардлагад нийцсэн бүтээгдэхүүн гаргадгийг харуулах баталгаажуулалтын үе шат юм.<\/p>\n","protected":false},"author":234312599,"featured_media":8489,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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