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UNSPSC Code:
41106225
NACRES:
NA.74
eCl@ss:
32014001
Bottle capacity:
125 mL
Bottle filling volume:
100 mL
Feature:
closure type Red screw cap with septum and protector, ready-to-use
Agency:
in accordance with EP 2.6.1, in accordance with JP 4.06, in accordance with USP 71
Ph:
7.1
Quality Segment
agency
in accordance with EP 2.6.1, in accordance with JP 4.06, in accordance with USP 71
sterility
sterile; ethylene oxide treated
form
liquid
feature
closure type Red screw cap with septum and protector, ready-to-use
packaging
double packed of 12 bottles
bottle capacity
125 mL
bottle filling volume
100 mL
input
sample type pharmaceutical(s)
pH
7.1
application(s)
pharmaceutical
sterility testing
compatibility
for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01), for use with Steritest®
shipped in
ambient
storage temp.
2-30°C
suitability
anaerobic bacteria
General description
流体巯基乙酸盐培养基(FTM)是我们STERITEST® 溶液的关键组分。本品的处方和检测符合EP 2.6.1、USP 71和JP 4.06的要求。我们的制造方法确保了我们的培养基的最高质量水平,提高了准确性,并大大降低了错误解释和错误结果的风险。灭菌的双层Tyvek®包装可简化清洁程序,以最大程度地降低层流罩中的交叉污染风险,并确保隔离器腔室的有效去污。液体呈浅黄色、微乳白色和粘性,混悬液中有粉红色环≤1厘米。产品的pH值为7.1±0.2,可在2-25℃下保存。孵育温度在30-35℃之间变化,孵育时间为7-14天。该产品以12瓶100 mL培养基的形式提供,带有隔膜密封件的螺旋盖,可降低交叉污染和生长抑制的风险。
Application
无菌检查(膜过滤和直接接种)
生物负荷测试
生物负荷测试
流体巯基乙酸培养基(FTM)主要用于检测厌氧菌。但是,它也可以进行需氧细菌检测。QC微生物包括生孢梭菌(ATCC 19404)、金黄色葡萄球菌(ATCC 6538)和铜绿假单胞菌(ATCC 9027)。该培养基用于通过薄膜过滤法或直接接种法进行无菌检查。
Preparation Note
流体巯基乙酸盐
Analysis Note
浑浊表明生长
Other Notes
带隔膜的螺旋盖
Legal Information
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
Tyvek is a registered trademark of E. I. du Pont de Nemours and Company
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存储类别
12 - Non Combustible Liquids