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제품정보 (DICE 배송 시 비용 별도)
UNSPSC Code:
41106214
NACRES:
NA.74
eCl@ss:
32014001
Bottle capacity:
500 mL
Bottle filling volume:
300 mL
Feature:
closure type Black 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
description
For rinsing of solutions containing oil or lecithin
sterility
sterile; autoclaved
form
liquid
shelf life
17 mo.
feature
closure type Black screw cap with septum and protector, ready-to-use
packaging
pack of 4 bottles
bottle capacity
500 mL
bottle filling volume
300 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
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
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.
Sterility testing
Bioburden testing
Bioburden testing
Preparation Note
Fluid D
Legal Information
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
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저장 등급
12 - Non Combustible Liquids