Fluid D

半岛bd体育手机客户端 说明

一般描述

Fluid D is suitable for testing samples that contain lecithin or oil, and compatible with most antibiotics. Composition of this fluid comply with the European Pharmacopeia (EP) 2.6.1, United States Pharmacopeia (USP) 71 and Japanese Pharmacopeia (JP) 4.06. This is a clear colorless fluid and the pH of the product is 7.1 ± 0.2 at 25℃. It can be stored at 2-25℃ (protected from light) for 17 months. One box of product contains 4 bottles of 300 mL of fluid. Each bottle has a screw cap with a septum to minimize the risks of cross-contamination and optimize the disinfection procedures.

应用

Sterility testing
Bioburden testing
Fluid D can be used in combination with the STERITEST^?sterility testing system for the rinsing of solutions containing oil or lecithin during sterility testing by membrane filtration. It can also be used for the removal of antimicrobial activity by membrane filtration for non-sterile products. The fluid is also excellent for rinsing sterile pathways of devices, and typically used for rinse method testing of medical devices.

组分

装有隔膜的螺旋盖

半岛bd体育手机客户端 规格

美国药典、欧洲药典、日本药典

培养基

冲洗液 D

分析说明

QC organisms
S. aureus(ATCC 6538)

B. subtilis(ATCC 6633)

P. aeruginosa(ATCC 9027)

C. albicans(ATCC 10231)

A. niger(ATCC 16404)

生孢梭菌(ATCC 11437)
Target Microorganisms: 清洗缓冲液和附加剂

法律信息

STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany

基本信息

eCl@ss	32014001
NACRES	NA.74

半岛bd体育手机客户端 性质

质量水平	400
agency	in accordance with EP 2.6.1 in accordance with JP 4.06 in accordance with USP 71
无菌性	sterile; autoclaved
形式	liquid
保质期	17 mo.
特点	ready-to-use
包装	pkg of 300 mL (Bottle with screw cap and septum) pack of 4 bottles
体积尺寸	300 mL
颜色	clear, with no precipitate and free of visible particles
input	sample type pharmaceutical(s)
pH值(酸碱度)	7.1±0.2 (25.0 ℃)
application(s)	pharmaceutical sterility testing
相容性	for use with Steritest?
运输	ambient
储存温度	2-30℃
适用性	nonselective for

安全信息

储存分类代码	12 - Non Combustible Liquids
WGK	WGK 1
闪点(F)	Not applicable
闪点(C)	Not applicable