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1.46779

Fluid K - Ready-to-use Rinse Fluid

bottle capacity 500 mL, bottle filling volume 500 mL, closure type, Blue flip cap with septum, pack of 6 bottles

Synonym(s):

Diluting Fluid K, Fluid K, Fluid K for Sterility Testing, Rinse Fluid, Rinsing Solution Fluid K, Washing Fluid

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About This Item

UNSPSC Code:
41106214
Bottle capacity:
500 mL
Bottle filling volume:
500 mL
Feature:
closure type Blue flip cap with septum, ready-to-use
Agency:
EP (2.6.13), JP (4.06), USP
(71)
Ph:
6.7-7.1
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material

glass bottle

Quality Level

300

agency

EP (2.6.13), JP (4.06), USP
(71)

sterility

sterile; autoclaved (tested for 14 days at 20-25°C and 30-35°C)

form

liquid

shelf life

180 days

feature

closure type Blue flip cap with septum, ready-to-use

composition

Beef Extract, 3 g , Peptic Digest of Animal Tissue, 5 g , Tween® 80, 10 g

packaging

pack of 6 bottles

technique(s)

microbiological culture: suitable, sterile filtration: suitable

bottle capacity

500 mL

bottle filling volume

500 mL

color

clear slightly to yellowish

pH

6.7-7.1

application(s)

pharmaceutical
sterility testing

compatibility

for use with Sterility Testing

storage temp.

2-25°C

suitability

nonselective for bacteria

General description

Fluid K is designed as a washing solution for sterility testing of petrolatum solutions or oil-soluble pharmaceutical products using the membrane filtration method. Post filtration, the membranes are rinsed with Fluid K, whose composition also supports the growth of microorganisms upon incubation.

Application

Fluid K is suitable for sterility testing of petrolatum products or oil-soluble pharmaceutical products. The washing solution serves as a medium for the growth of microorganisms in test samples. The fluid is also excellent for rinsing pathways of medical devices and products that are difficult to filter or dissolve.

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 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.

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.

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Storage Class

12 - Non Combustible Liquids

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

新产品

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Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Global Trade Item Number

SKUGTIN
146779000604061838830852