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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 green screw cap with septum, ready-to-use
Agency:
in accordance with EP 2.6.1, in accordance with JP 4.06, in accordance with USP 71
Ph:
7.3
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 green screw cap with septum, ready-to-use
packaging
double packed of 12 bottles
bottle capacity
125 mL
bottle filling volume
100 mL
input
sample type pharmaceutical(s)
pH
7.3
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
nonselective for
General description
大豆酪蛋白消化肉汤是一种无菌培养基,是我们STERITEST® 溶液的关键组分。该培养基的组成和生长性能符合欧洲药典(EP)2.6.1、美国药典(USP)71和日本药典(JP)4.06的要求,适用于大豆酪蛋白消化物培养基。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。经过消毒的双层 Tyvek® 包装提高了测试方法的可靠性,可以简化清洁程序,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。培养基外观为淡黄色澄清液体。pH值为7.3±0.2,储存稳定为2-25℃。孵育温度在20-25℃之间变化,孵育时间为7-14天。该产品以12瓶100 ml培养基、带隔膜密封件的螺旋盖形式提供,可最大程度降低交叉污染风险并优化消毒程序。
Application
大豆酪蛋白消化物培养基预期用于检测需氧菌和真菌。QC微生物包括枯草芽孢杆菌(ATCC 6633)、白色念珠菌(ATCC 10231)、巴西曲霉(黑曲霉)(ATCC 16404)、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。它也可用作非无菌产品的预富集肉汤。
无菌检查(膜过滤和直接接种)
生物负荷测试
生物负荷测试
Preparation Note
胰蛋白胨大豆
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
flash_point_f
Not applicable
flash_point_c
Not applicable