版本号 Version No | 修改日期 Modified Date | 修改内容描述 Description about modified content 的重要性英语 |
A | 家务的英文2020.3.16 | ● 首次发布 Initial Relead |
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制定：Draft 签名 Sign | 审核：Review 签名 Sign | 批准：Approval 签名 Sign |
发放部门 Distribution department | 研发中心、质量法规、生产运营、物料管理 R&D，Quality regulation, Operation department, Material management department. |
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1.0 目的 Purpo
对环氧乙烷灭菌进行控制，保证文件的适用性和有效性。
Control of ethylene oxide sterilization to ensure the suitability and effectiveness of the documentation.
2.0 范围 Scope
适用于本公司环氧乙烷灭菌产品控制。
Suitable for the control of our company's ethylene oxide sterilization products
3.0 职责Responsibility
3.1研发中心：负责提供产品材料所能够承受的灭菌方式，且满足设定的灭菌条件。
R&D: Responsible for providing the sterilization method that the product materials can withstand and meet the t sterilization conditions.
3.2生产运营：负责准备灭菌的产品。
Operation department: Responsible for preparing products for sterilization
3.3质量法规：负责灭菌供商的审核，灭菌验证；灭菌前、后产品指标的检测，审核灭菌公司提供灭菌报告；
Quality regulations: responsible for the audit of sterilization suppliers, sterilization verification; testing of product indicators before and after sterilization, and inspection of sterilization reports provided by the company.
3.4物料管理：负责外包装后，产品放行前（灭菌前、后）的隔离，灭菌货物的运输、与灭菌公司的
灭菌协议签订和沟通。
Material management: After being responsible for the outer packaging, the product is relead before the relea (before and after sterilization), the transportation of the sterilized goods, and the sterilization agreement with the sterilization company.
4.0 程序 Process
4.1定义 definition
4.1.1灭菌批：在同一灭菌柜内，同一灭菌条件下，满足同灭菌要求的一定量的产品。
Sterilization batch: a certain amount of products that meet the sterilization requirements under the same sterilization conditions in the same sterilizer.
4.1.2 SAL=Sterility Assurance Level 无菌保证水平，表示已灭菌物品的微生物存活的概率。
Aptic assurance level, indicating the probability of microbial survival of sterilized items.
4.1.3 BI=Biological Indicator生物指示物，对特定灭菌过程具有确定抗力的染菌测试系统。
Biological indicator, a bacterial test system with defined resistance to a specific sterilization process.
4.2灭菌供商选择及评价 Sterilization supplier lection and evaluation
4.2.1对供货商的质量管理和生产能力评估（查看供商的资质、现场审核等方式）。
Quality management and production capacity asssment for suppliers (check supplier qualifications, on-site audits, etc.)
4.2.2 对灭菌厂商评估的项目：
Project for evaluation of sterilization manufacturers
A) 确认灭菌设备是经过安装验证和运行验证。
Confirm that the sterilization equipment is verified by installation and verified by operation
B) 确认灭菌操作员是经过专业培训并持有上岗证。
Confirm that the sterilization operator is professionally trained and holds a certificate of employment.
在线背单词C) 确认质量体系相关文件的建立。
Confirm the establishment of relevant documents of the quality system.
D) 灭菌过程是经过确认，并能够提供符合要求的报告。subscriber
The sterilization process should be confirmed and can provide a report that meets the requirements
E) 当更换灭菌公司或者出现无菌不合格情况时，需要重新进行灭菌验证。
When the sterilization company is replaced or the sterility is unqualified, the sterilization verification needs to be repeated.
4.3验证前设定Pre-verification tting
4.3.1对需要灭菌产品，根据产品风险分析，规定产品的SAL。
nippon paintProducts that require sterilization, according to product risk analysis, specify the SAL of the product.
4.3.2对灭菌产品做灭菌的抗性对比。新产品与已确认产品灭菌做抗性对比。使用新产品的短周期与已确认产品进行产品生物负载（BI）评估，即生物指示物（BI）抗性对比。
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).
4.4首次验证流程First verification process
4.5灭菌再验证 caerphillyRe-validation
在设备符合性的前提下（即IQ、OQ完成），进行以下确认：
On the premi of equipment compliance (ie IQ, OQ completed), confirm the following
4.5.1 灭菌再验证进行短周期、半周期、整周期确认。
Sterilization and re-verification for short cycle, half cycle, and full cycle confirmation.
4.5.2 验证过程所使用的产品和装载的灭菌难度与日常灭菌所具备的灭菌难度相同。
The sterilization process of the products and loads ud in the verification process is the same as the sterilization difficulty of daily sterilization.
新东方西安分校4.5.3 明确说明载荷物品，灭菌验证PQ过程中选择的载荷物品须与日常灭菌产品密度一致。
Defining the load item clearly, the load item lected during the sterilization verification PQ process must be consistent with the daily sterilization product density.
4.5.4 灭菌验证中明确装载模式：包装、装载的密度、装载示意图、装载最大量、包装材料尺寸、托盘尺寸。
maple是什么意思va国际教育Loading mode in sterilization validation: packaging, loading density, loading schematic, maximum loading, packaging material size, tray size.cathou
