表1总结了无菌产品的范畴。
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。
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.
作为药品生产单位,无菌注射剂生产中污染的控制及无菌检查直接影响到无菌产品的微生物方面的质量控制。
As to be the drag manufacturer, it will directly influence the biological quality control of sterility product that the contaminations control during injection production and sterility test.
这种产品在是工业无菌的。
大多数消费者使用无菌包装的产品,才在形式上的无菌果汁盒子。
Most consumers have used aseptically packaged products before in the form of the aseptic juice box.
在瑞士还有另一种无菌药品由于注射溶液中产品结晶(形成颗粒)需要召回。
Another sterile medicinal product had to be recalled in Switzerland because of crystallization of the product (particle formation) in the solution for injection.
按照下面供试产品无菌检查项下的描述,使用除了下面变更之外完全相同的方法,进行试验。
Carry out a test as described below under test for Sterility of the Product to be Examined using exactly the same methods, except for the following modifications.
如果在复检中未发现微生物生长的证据,则该供试产品符合无菌试验的要求。
If no evidence of microbial growth is found in the repeat test, the product examined complies with the test for sterility.
如果膜过滤技术是不适合的,则使用在供试产品无菌检查法项下的培养基直接接种法。
If the membrane filtration technique is unsuitable, use the Direct Inoculation of the Culture Medium method under Test for Sterility of the Product to be Examined.
这些药典规定程序自身的设计不能确保一批产品无菌或已经灭菌。
These Pharmacopeial procedures are not by themselves designed to ensure that a batch of product is sterile or has been sterilized.
如果在复检中发现了微生物生长,则该产品不符合无菌试验。
If microbial growth is found in the repeat test, the product examined does not comply with the test for sterility.
因公司生产的产品为一次性无菌医疗器械产品,人员与产品的接触会影响产品的质量。
Because our products are sterile medical devices for single use, their quality will be adversely affected due to contact between human and products.
经过科学证明,质量回顾可以通过产品类型分类,如固体制剂、液体制剂、无菌制剂等。
Quality reviews may be grouped by product type, e. g. solid dosage forms, liquid dosage forms, sterile products, etc. where scientifically justified.
通过将选定的乳化剂在适当的无菌稀释液中乳化,例如液体A(见用于膜过滤的稀释和冲洗液),稀释至约1比10,来配制该产品。
Prepare by diluting to about 1 in 10 by emulsifying with the chosen emulsifying agent in a suitable sterile diluent such as Fluid A (see Diluting and Rinsing Fluids for Membrane Filtration).
如果没有找到微生物生长的证据,则该供试产品符合无菌检查。
If no evidence of microbial growth is found, the product to be examined complies with the test for sterility.
产品特点:本产品采用医用高分子材料制造,经环氧乙烷气体灭菌、无菌、无热原、无溶血反应、无急性全身毒性。
Product Feature: The products are made of medical high polymer, sterilized by EO-gas, sterile, pyrogen-free, non-hemolysis reaction, no acute systemic toxicity.
本产品无菌、无害,采用环氧乙烷灭菌处理,效果可靠。
This product aseptic, harmless, using epoxy ethane, reliable sterilization effect.
只要其性质许可,这些药品将使用供试产品无菌检查法项下的膜过滤法来检测。
Pharmacopeial articles are to be tested by the Membrane Filtration method under test for Sterility of the product to be Examined where the nature of the product permits.
第七条应当根据产品特性、工艺和设备等因素,确定无菌药品生产用洁净区的级别。
Article 7 Clean areas for the manufacture of sterile products are classified according to the properties of products, the characteristics of process and equipment used.
然后,产品将在灌装机的无菌区被灌装进纸盒内。
Next, the products are filled into the carton packs in the sterile aseptic zone of the filling machine.
产品质量——无菌,无毒,对皮肤刺激性为零,请放心使用。
This product has the quality of germ-free, nonpoisonous and no harsh to human skin, please feel easy to use.
“灵桥”牌带线缝合针系列产品的生产是在严格按照YY0033- 2000《无菌医疗器具生产管理规范》的要求下进行。
Linqiao "brand line of suture needle with the production of products in strict accordance with the YY0033-2000" the production of sterile medical devices regulations "to carry out the request."
无菌包装技术是指产品、包装容器、材料或包装辅助器材经灭菌后,在无菌的环境中进行充填和封口的一种包装方法。
Aseptic packaging technology refers to a method of filling and sealing in a sterile environment after products to be packaged and packaging containers, materials or AIDS are sterilized.
该产品非无菌状态提供,一次性使用。
The products not provide, the disposable use asepsis position.
我们的产品在无菌设备中生产。
各种包装材料适用于灭菌过程的规定,内包装密封性良好,能保证在产品有效期内内装物保持无菌。
All the package materials shall be suitable for sterilization process. The inner package shall have excellent air-tightness and ensure the product free of Bacterium within its shelf life.
本发明涉及一种养殖技术,具体涉及一种无菌蝇蛆的养殖方法,属农副产品加工技术领域。
The invention relates to breeding technology, in particular to a method for breeding aseptic fly maggots, and belongs to the technical field of agricultural product processing.
本发明涉及一种养殖技术,具体涉及一种无菌蝇蛆的养殖方法,属农副产品加工技术领域。
The invention relates to breeding technology, in particular to a method for breeding aseptic fly maggots, and belongs to the technical field of agricultural product processing.
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