{"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 הוא שלב האימות המשתמש בתא עיקור אתילן אוקסיד כדי להדגים שציוד העיקור אתילן אוקסיד פועל באופן עקבי בהתאם לקריטריוני קבלה שנקבעו מראש והתהליך מניב מוצר שהוא סטרילי ועומד בדרישות שצוינו.<\/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

In general, MPQ and PPQ are performed simultaneously.If PPQ is performed in parallel with at least three MPQ runs, then a minimum of one additional PPQ run shall be performed using the full cycle process specification. Physical PQ (PPQ) shall demonstrate that the specified acceptance criteria are met throughout the load for the duration of the proposed routine process specification.<\/p>\n\n\n\n

PQ shall be performed on the introduction of new or modified products,packaging, load configuration, Ethylene oxide sterilization chamber or process parameters unless equivalence to a previously validated product, packaging, load configuration Ethylene oxide sterilization chambernt or process has been documented.<\/p>\n\n\n\n

PQ verification Ethylene oxide sterilization chamber process<\/h2>\n\n\n\n

The process of PQ verification is generally as : perform a fractional cycle first, and test the sterility status of the product after
fractional
\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

Perform half cycle to prove the reproducibility of the sterilization process and sterilization effect; If the overkill method is used, then there should be no positive IPCD during half-cycle.Positive EPCD during the half cycle are acceptable if have demonstrated greater resistance than the IPCD providing a
\u201c
worst-case challenge
\u201d
for routine processing.<\/p>\n\n\n\n

The routine sterilization parameters are usually determined by the full cycle parameters, so residual challenges are generally done during the full cycle to determine the appropriate aeration time. Since the effectiveness of the sterilization process has been proven in fraction cycle and half cycles, the sterilization effect can be ensured by EPCD.<\/p>\n\n\n\n

If, in any of these runs, sterility or product functionality requirements are not met, an investigation should be conducted to determine if additional qualification runs are necessary. If process parameters cannot be maintained within the defined limits, an investigation should be conducted. If modifications are made, additional runs must be necessary.<\/p>\n\n\n\n

Annual PQ in Ethylene oxide sterilization chamber process<\/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

Assessment of equivalence<\/h2>\n\n\n\n

1.Process Equivalence?Ethylene oxide sterilization equipment that delivers the same process parameters, having undergone IQ<\/a> ו OQ<\/a>, shall be qualified either.<\/p>\n\n\n\n

2. in the same manner as the original chamber, or using a reduced MPQ that demonstrates the delivery of the required level of microbiological lethality and PPQ to demonstrate temperature and humidity uniformity of the load and control by the production chamber. The rationale for this reduced qualification shall be recorded and documented.<\/p>\n\n\n\n

3. The influence of different geographical locations on the product or load properties shall be determined.<\/p>\n\n\n\n

4. Process equivalence is a method used to demonstrate that the same validated sterilization process is delivered by two or more pieces or sets of Ethylene oxide sterilization equipment. It does not require that the equipment be physically identical. Even if the parameters delivered by the equipment are not statistically identical, the processes delivered can still be equivalent if they are all capable of running the process within the defined, validated process limits<\/p>\n\n\n\n

5. Process equivalence among multiple pieces of equipment is intended to minimize the amount of testing required to qualify the process. The sterilization process should be validated in one chamber. The remaining equipment can undergo reduced PQ if the remaining equipment has undergone installation qualification (IQ) and operational qualification (OQ) (see 9.2 and 9.3). Equivalence can also be used to reduce requalification of several pieces of equipment. The equipment used to deliver a sterilization process commonly consists of a chamber or room and ancillary control systems. Sterilization process equipment might be located within a given processing facility or among several facilities.This equipment can be used independently to deliver the same process conditions and could be exactly the same design or might differ in size or in the extent of ancillary equipment.<\/p>\n\n\n\n

6. Process equivalence among multiple pieces of equipment is intended to minimize the amount of testing required to qualify the process. The sterilization process should be validated in one chamber. The remaining equipment can undergo reduced PQ if the remaining equipment has undergone installation qualification (IQ) and operational qualification (OQ) (see 9.2 and 9.3). Equivalence can also be used to reduce requalification of several pieces of equipment. The equipment used to deliver a sterilization process commonly consists of a chamber or room and ancillary control systems. Sterilization process equipment might be located within a given processing facility or among several facilities.This equipment can be used independently to deliver the same process conditions and could be exactly the same design or might differ in size or in the extent of ancillary equipment.<\/p>\n\n\n\n

אם אתה רוצה לדעת יותר <\/h2>\n\n\n\n

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

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

אתר מקומי: חדר 1202, Caitong Zhongxin, מחוז שיאשה, העיר האנגג'ואו, מחוז ג'ג'יאנג, סין<\/p>\n\n\n\n

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

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

PQ הוא שלב האימות המשתמש בתא עיקור אתילן אוקסיד כדי להדגים שציוד העיקור אתילן אוקסיד פועל באופן עקבי בהתאם לקריטריוני קבלה שנקבעו מראש והתהליך מניב מוצר שהוא סטרילי ועומד בדרישות שצוינו.<\/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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Technical Team","author_link":"https:\/\/zjbocon.com\/?author=234312599"},"uagb_comment_info":18,"uagb_excerpt":"PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-xu","jetpack-related-posts":[{"id":3093,"url":"https:\/\/zjbocon.com\/?p=3093","url_meta":{"origin":2076,"position":0},"title":"Introduction to Ethylene Oxide Sterilizers","author":"Bocon Technical Team","date":"2025-02-05","format":false,"excerpt":"Discover how ethylene oxide sterilizers work, their applications, benefits, and safety considerations. Learn why they are essential for medical and industrial sterilization.","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/ethylene-oxide-sterilization-21.webp?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":2471,"url":"https:\/\/zjbocon.com\/?p=2471","url_meta":{"origin":2076,"position":1},"title":"Safety Requirements for Using Ethylene Oxide in sterilization","author":"Bocon Technical Team","date":"2024-12-23","format":false,"excerpt":"when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities. Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric\u2026","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Electrical-Scale.png?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":9665,"url":"https:\/\/zjbocon.com\/?p=9665","url_meta":{"origin":2076,"position":2},"title":"Automatic Conveyor Transmission System for Ethylene Oxide (EO) Sterilization","author":"Bocon Technical Team","date":"2026-06-10","format":false,"excerpt":"Automatic Conveyor System for Ethylene Oxide (EO) Sterilization | Technical Guide Automatic Conveyor Transmission System for Ethylene Oxide (EO) Sterilization Innovating safety and efficiency in full-process industrial Ethylene Oxide (EO) Sterilization logistics. Optimize Your EO Sterilization Logistics 1. Project Design Requirements for Ethylene Oxide (EO) Sterilization Logistics This automated project\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":2453,"url":"https:\/\/zjbocon.com\/?p=2453","url_meta":{"origin":2076,"position":3},"title":"Microbial Killing Performance of Ethylene Oxide Sterilizers","author":"Bocon Technical Team","date":"2024-12-20","format":false,"excerpt":"Note 1: The Ethylene Oxide sterilization conditions must be obtained through validation confirmation and should be verified with monitoring and routine control during each sterilization cycle. The requirements for validation and routine control are outlined in GB 18279. Note 2: This testing method is also applicable to A class Ethylene\u2026","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"eto sterilizer","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":2448,"url":"https:\/\/zjbocon.com\/?p=2448","url_meta":{"origin":2076,"position":4},"title":"eto sterilization Chamber Temperature Distribution Testing","author":"Bocon Technical Team","date":"2024-12-20","format":false,"excerpt":"The temperature of representative areas on the inner surfaces should be measured and recorded using temperature recording instruments that comply with the requirements of Appendix B.","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-54.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-54.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-54.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-54.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-54.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":3100,"url":"https:\/\/zjbocon.com\/?p=3100","url_meta":{"origin":2076,"position":5},"title":"How Does Ethylene Oxide Gas Sterilization Kill Microorganisms?","author":"Bocon Technical Team","date":"2025-02-05","format":false,"excerpt":"How Does Ethylene Oxide Gas Sterilization Work? The effectiveness of ethylene oxide gas sterilization lies in its ability to disrupt the cellular structure of microorganisms. Here\u2019s a step-by-step breakdown of how it works: 1.\u00a0Penetration of EO Gas Ethylene oxide gas is highly penetrative, meaning it can easily reach microorganisms even\u2026","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/tp2.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2076","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2076"}],"version-history":[{"count":9,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2076\/revisions"}],"predecessor-version":[{"id":2085,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2076\/revisions\/2085"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8489"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2076"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2076"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2076"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}