Methods The sterility test technology was applied after dry heat sterilization.
方法干热灭菌，用无菌检测技术检测。
Objective To discuss the current situation of drug sterility test in our country.
目的讨论目前我国药品无菌试验的实际情况。
A sterility test method for the Compound Sulfadiazine Zinc Cream was established.
建立复方磺胺嘧啶锌乳膏无菌检查法。
Conclusion The sterility test reassured by verification test is feasible and reliable.
方法采用直接接种法，通过无菌验证试验确定无菌检查方法的有效性。
Conclusion Sterility test medium manufacturers should be put in production license system.
结论应实行无菌试验培养基生产企业生产许可证制度。
Conclusion: The established sterility test method for Imipenem monohydrate may be practical.
结论：建立的亚胺培南一水合物无菌检查法可供实用。
Conclusion the established sterility test method of the Burn I oil agent is scientific and accurate.
结论采用该法对烧伤一号油剂进行无菌检查，方法可行，结果准确。
They are widely used for gravimetric analysis, microanalysis, colloid separation and sterility test.
广泛用于重量分析、微量分析、胶体分离及无菌实验中。
Conclusion: This method is accurate, it can be used for sterility test of Oxaliplatin for Injection.
结论：注射用奥沙利铂的无菌检查通过验证。
Objective To establish a methods for determining sterility test of Cefonicidum Natricum for Injection.
目的建立注射用头孢尼西钠的无菌检查方法。
Objective To establish and verify the sterility test method for Ginseng and Prepared Aconite Injection.
目的建立参附注射液无菌检查方法并对其进行验证。
Leading sterilization team on sterilization daily work, Microbiology lab routine work and sterility test.
领导灭菌团队的日常工作，微生物实验室和无菌测试管理。
Methods the method was based on the membrane filtration of sterility test of Chinese Pharmacopoeia 2005.
方法按《中国药典》2005年版附录无菌检查法项下薄膜过滤法。
Conclusion: The method is accurate and reliable. It can be used for sterility test of Xingnaojing injection.
结论：经方法学验证，醒脑静注射液无菌检查法准确可靠。
Methods: The validation for sterility test includes inhibition test for bacteria and fungi and irrigation test.
方法：无菌检查法的验证试验——抑细菌和抑真菌试验及冲洗量试验。
Objective:To determine the validity of membrane filtration method in the sterility test of little capacity injection.
目的探讨薄膜过滤法在小容量注射剂无菌检查中应用的可行性。
Objective:The suitable method was selected for the sterility tests of Imipenem Monohydrate to guarantee the test result accurate and reliable.
前言： 目的：选择对亚胺培南一水合物无菌检查的适宜检查方法，保证检验结果的准确性和可靠性。
Objective:To verify soybean-casein digest medium in USP whether or not substitute fungi medium in Pharmacopeia of P. R. China(ChP)by sterility test.
前言： 目的：验证美国药典用大豆- 酪蛋白消化物培养基能否替代中国药典无菌检查用的真菌培养基。
The microorganism which discovered in the production environment should take regularly uses in the sterility test method confirmation the challenge mold mushroom spawn;
在生产环境中发现的微生物应定期地作为用于无菌检查方法验证的挑战菌种；
Methods Sterility test, mycoplasma detection, pyrogen detection and abnormal toxicity test were performed respectively on culture supernatant of neural stem cells from bone marrow.
方法对骨髓源性神经干细胞的培养上清分别进行无菌试验、支原体检测、热原质检测和异常毒性试验。
The isolation system shall be validated according to the relevant requirements, and the cleanliness of the internal environment shall comply with the requirements of the sterility test.
隔离系统按相关的要求进行验证，其内部环境的洁净度须符合无菌检查的要求。
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.
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。
The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed.
无菌检查应在无菌条件下进行，为了达到该条件，检测环境应符合无菌检查的规定。
If no evidence of microbial growth is found in the repeat test, the product examined complies with the test for sterility.
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 microbial growth is found in the repeat test, the product examined does not comply with the test for sterility.
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。
The test for sterility may then be carried out without further modification.
然后，无菌试验可以进行，而无需进一步的变更。
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.
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。
If no evidence of microbial growth is found, the product to be examined complies with the test for sterility.
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 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.
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。
The validated method can be used to test for sterility of Cefpirome Sulfate for Injection.
采用验证过的试验方法进行注射用硫酸头孢匹罗的无菌检查可行。
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