1.46468

Lösung D – Gebrauchsfertige Spüllösung

Peptone 1 g, bottle capacity 125 mL, bottle filling volume 100 mL, closure type, Yellow flip cap with septum, pack of 10 bottles

• Synonym(e): Fluid D, Rinsing solution, Washing fluid
• UNSPSC Code: 41106214
• Bottle capacity: 125 mL
• Bottle filling volume: 100 mL
• Feature: closure type Yellow flip cap with septum, ready-to-use
• Agency: EP 2.6.1, JP 4.06, USP 71; 71
• Ph: 6.5-7.5

Eigenschaften

• Quality Level: 300
• material: glass bottle
• agency: EP 2.6.1, JP 4.06, USP 71; 71
• sterility: sterile; autoclaved (tested for 14 days at 20-25°C and 30-35°C)
• form: liquid
• shelf life: 360 days
• feature: closure type Yellow flip cap with septum, ready-to-use
• composition: Dithiothreitol, 0.31 g , Peptone, 1 g , Sodium-Thioglycollate, 0.5 g , Tween^® 80, 1 mL
• packaging: pack of 10 bottles
• technique(s): sterile filtration: suitable
• bottle capacity: 125 mL
• bottle filling volume: 100 mL
• pH: 6.5-7.5
• application(s): cosmetics; food and beverages; pharmaceutical; sterility testing
• storage temp.: 2-25°C
• suitability: nonselective for

Beschreibung

General description

Fluid D with Sodium Thioglycollate and 1,4-Dithiothreitolis a washing solution for sterility testing of pharmaceutical samplescontaining lecithin or oil using the membrane filtration method.Rinse the membrane with Fluid D after filtration and provide a suitable mediumto observe microbial growth.
Sodium Thioglycollate facilitates the growth ofaerobic and anaerobic microorganisms in the test sample and 1,4-Dithiothreitolensures complete detachment from the sample e.g. prosthetic implant or medicaldevices.

Application

Fluid D is suitablefor rinsing the solutions containing oil or lecithin during sterility testingby membrane filtration. It is also suitable for the removal of antimicrobialactivity of non-sterile products by membrane filtration. The fluid is alsoexcellent for rinsing sterile pathways of devices and is used for rinse methodtesting of medical devices.

Features and Benefits

• Our ready-to-use mediaprovide the highest level of quality and testing confidence. They areformulated and tested to meet the pharmacopeia requirements.
• Sterility testing media andrinse solutions are manufactured in an ISO 9001, environmentally controlledproduction center. Each lot undergoes a stringent quality control (QC) procedure, including pH, sterility, and growth promotion tests.
• Our manufacturing approachensures the highest level of clarity for our media and rinsing fluids, thusimproving accuracy, and reducing the risk of incorrect interpretation and falseresults.
  

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.

Legal Information

TWEEN is a registered trademark of Croda International PLC

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

• wgk: WGK 1
• Lagerklasse: 12 - Non Combustible Liquids