1.46806

Lösung D – Gebrauchsfertige Spüllösung

bottle capacity 500 mL, bottle filling volume 500 mL, closure type, Red screw cap with 3 loci, pack of 6 bottles

• Synonym(e): Fluid D, Fluid D for Sterility Testing, Rinse fluid, Rinsing Solution Fluid D, Washing Fluid
• UNSPSC Code: 41106214
• Bottle capacity: 500 mL
• Bottle filling volume: 500 mL
• Feature: closure type Red screw cap with 3 loci, ready-to-use
• Agency: EP (2.6.13), JP (4.06), USP (71)
• Ph: 6.9-7.3

Eigenschaften

• material: glass bottle
• agency: EP (2.6.13), JP (4.06), USP (71)
• sterility: sterile; autoclaved (tested for 14 days at 30-35°C and 20-25°C)
• form: liquid
• shelf life: 360 days
• feature: closure type Red screw cap with 3 loci, ready-to-use
• composition: Peptone, 1 g , Polysorbate 80, 1 mL
• packaging: pack of 6 bottles
• technique(s): direct inoculation: suitable, microbiological culture: suitable
• bottle capacity: 500 mL
• bottle filling volume: 500 mL
• pH: 6.9-7.3
• application(s): pharmaceutical; sterility testing
• storage temp.: 2-25°C
• suitability: nonselective for bacteria

Beschreibung

General description

Fluid D is a washing solution for sterility testing of pharmaceutical samples containing lecithin or oil using the membrane filtration method.
Rinse the membrane with Fluid D after filtration and provide a suitable medium to observe microbial growth.

Application

Fluid D is suitable for rinsing the solutions containing oil or lecithin during sterility testing by membrane filtration. It is also suitable for the removal of antimicrobial activity of non-sterile products by membrane filtration. The fluid is also excellent for rinsing sterile pathways of devices and is 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 pharmacopeia 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, thus improving accuracy and reducing the risk of incorrect interpretation and false results.

Analysis Note

The appearance of the medium is clear and colorless to slightly yellowish.

Other Notes

Production will take place at Millipore SAS in Molsheim, France. Deliveries will be executed in accordance with the terms and conditions of MLS RTU GmbH. A minimum order quantity is required to process the order. Once the order is placed and confirmed, Merck will ensure product delivery within a maximum timeframe of 10 to 12 weeks. The terms and conditions of Merck KGaA apply to both Millipore SAS and MLS RTU GmbH and can be accessed through the following link: Standard Terms & conditions

This medium can be modified and/or supplemented based on the required performance criteria.

Disclaimer

This item is created at the customer′s request as a customized product and will not be developed or qualified in accordance with the Merck Product Development Process.

Sicherheitshinweise

• flash_point_f: Not applicable
• flash_point_c: Not applicable
• Lagerklasse: 12 - Non Combustible Liquids