STBMRFD34

Fluid D

bottle of, ready-to-use, bottle volume 300 mL , filling volume

• Synonym(s): Rinse Fluid, Washing Fluid
• UNSPSC Code: 41106214
• eCl@ss: 32014001
• NACRES: NA.74

Properties

• Agency: in accordance with EP 2.6.1; in accordance with JP 4.06; in accordance with USP 71
• Quality Level: 400
• description: For rinsing of solutions containing oil or lecithin
• sterility: sterile; autoclaved
• form: liquid
• shelf life: 17 mo.
• feature: closure type screw cap with septum; ready-to-use
• packaging: bottle of
• bottle volume: 300 mL , filling volume; 500 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

Description

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

Culture Medium

Fluid D

Legal Information

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

Safety Information

• Storage Class Code: 12 - Non Combustible Liquids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable