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STBMRFD34
Fluid D
pkg of 300 mL (Bottle with screw cap and septum), For rinsing of solutions containing oil or lecithin, suitable for sterility testing, for use with Steritest®
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Synonym(s):
Washing Fluid, Rinse Fluid
eCl@ss:
32014001
NACRES:
NA.74
Quality Level
Agency
in accordance with EP 2.6.1
in accordance with JP 4.06
in accordance with USP 71
sterility
sterile; autoclaved
form
liquid
shelf life
17 mo.
feature
ready-to-use
packaging
pkg of 300 mL (Bottle with screw cap and septum)
pack of 4 bottles
volume size
300 mL
color
clear, with no precipitate and free of visible particles
input
sample type pharmaceutical(s)
pH
7.1±0.2 (25.0 °C)
application(s)
pharmaceutical
sterility testing
compatibility
for use with Steritest®
shipped in
ambient
storage temp.
2-30°C
suitability
nonselective for
General description
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°C. It can be stored at 2-25°C (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.
Application
Sterility testing
Bioburden 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.
Culture Medium
Fluid D
Legal Information
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
Storage Class Code
12 - Non Combustible Liquids
WGK
WGK 1
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
Certificate of Analysis
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Certificate of Quality
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