Your firm must use garments that are suitable for aseptic processing.
你们公司必须使用适合无菌工艺的防护服。
If multiple sterile bags are used, operations should be performed in aseptic processing areas.
如果用到多重无菌袋子，操作应在无菌处理区进行。
Validation of aseptic processing should include a process simulation test using a nutrient medium (media fill).
无菌生产过程的验证，要包括利用营养培养基进行的模拟试验。
In response to this letter, perform a full review of aseptic processing equipment design and aseptic techniques.
在回复此函时，请对无菌加工设备设计和无菌技术进行全面审核。
This is accomplished primarily by validation of the sterilization process or of the aseptic processing procedures.
这主要是通过灭菌工艺或者无菌操作程序的验证来完成。
In addition, it is critical that your aseptic processing operators have the knowledge and skills to practice strict aseptic techniques.
此外，你们的无菌操作人员要有实践严格无菌技术的知识和技能是很关键的。
We believe that industry and regulatory communities currently find themselves caught on the horns of a dilemma regarding aseptic processing.
我们相信，现在制药公司和药证机构发现他们对于“无菌工艺”处于进退两难之间。
Your aseptic processing gowns were inadequate to prevent contamination of your sterile products with particles and microorganisms shed from employees' bodies.
你们的无菌操作衣不足以防止你们的无菌药品受到来自员工身体脱落的颗粒物和微生物的污染。
SIP is often a pivotal step of aseptic processing for sterile product manufacture, and as such, may benefit from the application of risk management methodologies.
对于无菌产品的生产，SIP经常是无菌处理的关键环节，因此，可以从风险管理方法的应用中受益。
Aseptic processing equipment should provide for appropriate ergonomics that enable operators to reproducibly conduct aseptic manipulations.
无菌加工设备应提供适当的人体工程学保证，使得操作人员可以重复实施无菌操作。
Aseptic processing equipment should provide for appropriate ergonomics that enable operators to reproducibly conduct aseptic manipulations.
无菌加工设备应提供适当的人体工程学保证，使得操作人员可以重复实施无菌操作。
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