1.46483

Fluid D

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

• Synonym(s): Rinse Fluid, Washing Fluid
• UNSPSC Code: 41106200

Properties

• Agency: EP 2.6.1; JP 4.06; USP 71
• Quality Level: 300
• sterility: sterile; autoclaved
• form: liquid
• shelf life: 12 mo.
• feature: closure type crimp cap with septum; ready-to-use
• packaging: bottle of ; pkg of (300 ml in 500 ml bottle with yellow flip cap and septum (6 bottles per box))
• technique(s): sterile filtration: suitable
• bottle capacity: 500 mL
• bottle volume: 300 mL , filling volume
• pH: 7.1
• application(s): cosmetics; food and beverages; 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)
• storage temp.: 2-25°C
• suitability: nonselective for

Description

General description

Fluid D is a suitable washing solution for sterility testing of pharmaceutical products containing lecithin or oil. The medium can be adjusted and/or supplemented according to the required performance criteria.

Application

Fluid D may be used for performing sterility tests of articles containing lecithin or oil using 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.

Features and Benefits

Our ready to use media provide the highest level of quality and testing confidence. They have been formulated and tested to meet the pharmacopoeia requirements. Sterility testing media and rinse solutions are manufactured in an ISO 9001, environmentally controlled production center. Each lot undergoes a stringent quality control (QC) procedure, including pH, sterility and growth promotion tests. Our manufacturing approach ensures the highest level of clarity for our media and rinsing fluids, therefore improving accuracy and significantly reducing the risk of incorrect interpretation and false results.

Legal Information

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

Safety Information

• Storage Class Code: 10 - Combustible liquids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable