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Merck
CN

1.46806

Fluid D - Ready-to-use Rinse Fluid

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

Synonym(s):

Fluid D, Fluid D for Sterility Testing, Rinse fluid, Rinsing Solution Fluid D, Washing Fluid

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About This Item

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

Key Documents

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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

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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.

Storage Class

12 - Non Combustible Liquids

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

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