1、環(huán)氧乙烷滅菌過(guò)程控制規(guī)范Ethylene Oxide Sterilization Process Control Specification版權(quán)所有，注意保密JMSZ-MOS-SP-110Rev A第1頁(yè)共7頁(yè)版本號(hào)VersionNo修改日期Modified Date修改內(nèi)容描述Description about modified contentA2020.3.16首次發(fā)布Initial Released制定：Draft審核：Review批準(zhǔn)：Approval簽名Sign簽名Sign簽名Sign發(fā)放部門(mén)Distribution department研發(fā)中心、質(zhì)量法規(guī)、生產(chǎn)運(yùn)營(yíng)、物料管理R&D

2、, Quality regulation, Operation department, Material management department.1.0 目的 Purpose對(duì)環(huán)氧乙烷滅菌進(jìn)行控制，保證文件的適用性和有效性。Control of ethylene oxide sterilization to ensure the suitability and effectiveness of the documentation.e環(huán)氧乙烷滅菌過(guò)程控制規(guī)范Ethylene Oxide Sterilization Process Control Specification版權(quán)所有，注意保密J

3、MSZ-MOS-SP-110Rev A第2頁(yè)共7頁(yè)范圍 Scope適用于本公司環(huán)氧乙烷滅菌產(chǎn)品控制。Suitable for the control of our companys ethylene oxide sterilization products職責(zé) Responsibility研發(fā)中心：負(fù)責(zé)提供產(chǎn)品材料所能夠承受的滅菌方式，且滿足設(shè)定的滅菌條件。R&D: Responsible for providing the sterilization method that the product materials can withstand and meet the set steril

4、ization conditions.生產(chǎn)運(yùn)營(yíng)：負(fù)責(zé)準(zhǔn)備滅菌的產(chǎn)品。Operation department: Responsible for preparing products for sterilization質(zhì)量法規(guī)：負(fù)責(zé)滅菌供商的審核，滅菌驗(yàn)證；滅菌前、后產(chǎn)品指標(biāo)的檢測(cè)，審核滅菌公司提 供滅菌報(bào)告；Quality regulations: responsible for the audit of sterilization suppliers, sterilization verification; testing of product indicators before and a

5、fter sterilization, and inspection of sterilization reports provided by the company.物料管理：負(fù)責(zé)外包裝后，產(chǎn)品放行前(滅菌前、后)的隔離，滅菌貨物的運(yùn)輸、與滅菌公司的 滅菌協(xié)議簽訂和溝通。Material management: After being responsible for the outer packaging, the product is released before the release (before and after sterilization), the transportati

6、on of the sterilized goods, and the sterilization agreement with the sterilization company.4.0 程序 Process定義 definition滅菌批：在同一滅菌柜內(nèi)，同一滅菌條件下，滿足同滅菌要求的一定量的產(chǎn)品。Sterilization batch: a certain amount of products that meet the sterilization requirements under the same sterilization conditions in the same ster

7、ilizer.SAL=Sterility Assurance Level無(wú)菌保證水平，表示已滅菌物品的微生物存活的概率。Aseptic assurance level, indicating the probability of microbial survival of sterilized items.BI=Biological Indicator生物指示物，對(duì)特定滅菌過(guò)程具有確定抗力的染菌測(cè)試系統(tǒng)。Biological indicator, a bacterial test system with defined resistance to a specific sterilizatio

8、n process.滅菌供商選擇及評(píng)價(jià)Sterilization supplier selection and evaluation對(duì)供貨商的質(zhì)量管理和生產(chǎn)能力評(píng)估(查看供商的資質(zhì)、現(xiàn)場(chǎng)審核等方式)。Quality management and production capacity assessment for suppliers (check supplier qualifications, on-site audits, etc.)e環(huán)氧乙烷滅菌過(guò)程控制規(guī)范Ethylene Oxide Sterilization Process Control Specification版權(quán)所有，注意保

9、密JMSZ-MOS-SP-110Rev A第3頁(yè)共7頁(yè)對(duì)滅菌廠商評(píng)估的項(xiàng)目：Project for evaluation of sterilization manufacturersA）確認(rèn)滅菌設(shè)備是經(jīng)過(guò)安裝驗(yàn)證和運(yùn)行驗(yàn)證。Confirm that the sterilization equipment is verified by installation and verified by operationB）確認(rèn)滅菌操作員是經(jīng)過(guò)專(zhuān)業(yè)培訓(xùn)并持有上崗證。Confirm that the sterilization operator is professionally trained and h

10、olds a certificate of employment.C）確認(rèn)質(zhì)量體系相關(guān)文件的建立。Confirm the establishment of relevant documents of the quality system.D）滅菌過(guò)程是經(jīng)過(guò)確認(rèn)，并能夠提供符合要求的報(bào)告。The sterilization process should be confirmed and can provide a report that meets the requirementsE）當(dāng)更換滅菌公司或者出現(xiàn)無(wú)菌不合格情況時(shí)，需要重新進(jìn)行滅菌驗(yàn)證。When the sterilization co

11、mpany is replaced or the sterility is unqualified, the sterilization verification needs to be repeated.驗(yàn)證前設(shè)定 Pre-verification setting對(duì)需要滅菌產(chǎn)品，根據(jù)產(chǎn)品風(fēng)險(xiǎn)分析，規(guī)定產(chǎn)品的SAL。Products that require sterilization, according to product risk analysis, specify the SAL of the product.對(duì)滅菌產(chǎn)品做滅菌的抗性對(duì)比。新產(chǎn)品與已確認(rèn)產(chǎn)品滅菌做抗性對(duì)比。使用新產(chǎn)品的

12、短周期與已確認(rèn)產(chǎn)品進(jìn)行產(chǎn)品生物負(fù)載（ BI）評(píng)估，即生物指示物（BI）抗性對(duì)比。Comparison of resistance to sterilization of sterilized products. The new product is compared with the confirmed sterilization of the product. Bioburden （BI） resistance comparison using short-term cycles of new products and confirmed products for bioburden （BI

13、）.首次驗(yàn)證流程 First verification process環(huán)氧乙烷滅菌過(guò)程控制規(guī)范Ethylene Oxide Sterilization Process Control Specification版權(quán)所有，注意保密JMSZ-MOS-SP-110Rev A第4頁(yè)共7頁(yè)短周期循環(huán)（確認(rèn)BI）存活）溫度、壓力下限，時(shí)間一半以 下，加濕上或下限實(shí)施1次BI存活嗎？NO確認(rèn)培養(yǎng)條件、培養(yǎng)基性能、BI應(yīng)設(shè)定BI能存活的時(shí)間（7天）yes半周期確認(rèn)（時(shí)間：一半）溫度、壓力、加濕：全下 限條件實(shí)施3次溫度、壓力下限、加濕上 限實(shí)施1次結(jié)果設(shè)定：溫度、壓力、EO農(nóng)度的下限、 濕度上下限值（參考全周

14、期的結(jié)果）BI全部滅死嗎?NOyes確認(rèn)有無(wú)培養(yǎng)問(wèn)題確認(rèn)氣體有無(wú)滲透到BI（有無(wú)導(dǎo)管折痕）,品溫是否太低全周期確認(rèn)（時(shí)間：上限）溫度、壓力、加濕上限實(shí)施次產(chǎn)品性能評(píng)價(jià)、殘留EO結(jié)果設(shè)定：溫度、壓力、上限值各參數(shù)確認(rèn)、性能評(píng)價(jià)沒(méi)問(wèn)題嗎？NOyes確認(rèn)原因（特別是溫度、濕度）（若必要應(yīng)改變條件）結(jié)束：完成報(bào)告滅菌再驗(yàn)證 Re-validation在設(shè)備符合性的前提下（即IQ、OQ完成），進(jìn)行以下確認(rèn):On the premise of equipment compliance (ie IQ, OQ completed), confirm the following滅菌再驗(yàn)證進(jìn)行短周期、半周期、整周

15、期確認(rèn)。Sterilization and re-verification for short cycle, half cycle, and full cycle confirmation.驗(yàn)證過(guò)程所使用的產(chǎn)品和裝載的滅菌難度與日常滅菌所具備的滅菌難度相同。The sterilization process of the products and loads used in the verification process is the sameas the sterilization difficulty of daily sterilization.明確說(shuō)明載荷物品，滅菌驗(yàn)證PQ過(guò)程中選擇

16、的載荷物品須與日常滅菌產(chǎn)品密度一致。Defining the load item clearly, the load item selected during the sterilization verification PQprocess must be consistent with the daily sterilization product density.滅菌驗(yàn)證中明確裝載模式：包裝、裝載的密度、裝載示意圖、裝載最大量、包裝材料尺寸、托盤(pán)尺寸。環(huán)氧乙烷滅菌過(guò)程控制規(guī)范Ethylene Oxide Sterilization Process Control Specification

17、版權(quán)所有，注意保密JMSZ-MOS-SP-110Rev A第5頁(yè)共7頁(yè)Loading mode in sterilization validation: packaging, loading density, loading schematic, maximum loading, packaging material size, tray size.BI放置圖，BI應(yīng)放置于產(chǎn)品最難滅菌位置或難度相當(dāng)位置。BI placement: BI should be placed in the most difficult location of sterilization position or di

18、fficulty position.至少每年進(jìn)行一次滅菌再驗(yàn)證。Sterilization verification at least once a year滅菌再驗(yàn)證流程圖常規(guī)滅菌控制 Conventional sterilization control滅菌供應(yīng)商根據(jù)滅菌確認(rèn)形成的滅菌工藝參數(shù)和裝載方式等，進(jìn)行滅菌。Sterilize according to sterilization process parameters and loading methods confirmed by sterilization.按照SOP進(jìn)行日常滅菌裝箱操作。滅菌裝箱方式如有變動(dòng)，由質(zhì)量法規(guī)部人員進(jìn)行

19、評(píng)估 對(duì)滅菌有效性的影響。Daily sterilization and packing operations in accordance with SOP . If there is a change in the sterilization and packing method, the impact of the evaluation by the quality and regulations department on the effectiveness of sterilization.采購(gòu)應(yīng)與滅菌供方形成滅菌委托協(xié)議，在協(xié)議中明確滅菌要求和質(zhì)量責(zé)任。Procurement sho

20、uld form a sterilization entrustment agreement with the sterilization supplier, specifying the sterilization requirements and quality responsibility in the agreement.生產(chǎn)部負(fù)責(zé)整理滅菌產(chǎn)品清單，并填寫(xiě)委外滅菌單，將滅菌產(chǎn)品運(yùn)送或快遞至滅菌供方，滅菌供方根據(jù)滅菌協(xié)議進(jìn)行滅菌。The production department is responsible for sorting the list of sterilized prod

21、ucts, and filling out the “ External Sterilization Order ” , transporting or degvee sterilized products to thesterilizing supplier, and the sterilizing supplier sterilizes according to the sterilization protocol.e環(huán)氧乙烷滅菌過(guò)程控制規(guī)范Ethylene Oxide Sterilization Process Control Specification版權(quán)所有，注意保密JMSZ-MOS

22、-SP-110Rev A第6頁(yè)共7頁(yè)滅菌供方完成滅菌過(guò)程和BI檢測(cè)后返回本公司，同時(shí)出具環(huán)氧乙烷滅菌報(bào)告。The sterilization supplier completes the sterilization process and simultaneously issues the Ethylene Oxide Sterilization Report.質(zhì)量法規(guī)部負(fù)責(zé)對(duì)滅菌后的產(chǎn)品進(jìn)行檢驗(yàn)。The quality regulation department is responsible for inspecting the sterilized products.重新驗(yàn)證 Re-ver

23、ification當(dāng)滅菌設(shè)備或輔助系統(tǒng)有重大變更時(shí)需重新進(jìn)行滅菌驗(yàn)證。比如設(shè)備內(nèi)部結(jié)構(gòu)、加熱系統(tǒng)， 給蒸系統(tǒng)，控制系統(tǒng)等。Sterilization verification is required when there is a major change in the sterilization equipment or auxiliary system. Such as the internal structure of the equipment, the heating system, the steaming system, the control system, etc.當(dāng)發(fā)生以下

24、改變，需要重新評(píng)估是否需要進(jìn)行再驗(yàn)證When the following changes occur, need to re-evaluate whether need to re-verify產(chǎn)品包裝材質(zhì)、裝載方式(包括內(nèi)外包裝)變化Product packaging materials, loading methods (including internal and external packaging) changes裝載方式變化Loading method change生產(chǎn)設(shè)備變化Production equipment change原材料供貨商Raw material supplie

25、r change生產(chǎn)工藝變化Production process change生產(chǎn)環(huán)境變化Production environment change新產(chǎn)品增加(包括產(chǎn)品族建立、抗性評(píng)估)New product additions (including product family establishment, resistance assessment)生物負(fù)載變化(包括抗性評(píng)估)Bioburden changes (including resistance assessment)不合格品控制 Nonconforming product control在滅菌過(guò)程(包括滅菌驗(yàn)證過(guò)程)和檢測(cè)過(guò)程中發(fā)生不合格，依照不合格品控制程序執(zhí)行。Nonconforming occurs during the ste