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About This Item
UNSPSC Code:
41106214
agency
EP (2.6.13), JP (4.06), USP (71)
sterility
sterile; autoclaved
form
liquid
shelf life
12 mo.
feature
closure type Blue screw cap with 3 loci, ready-to-use
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
General description
Fluid A is a washing solution for sterility testing of aqueous solutions or water-soluble pharmaceutical products using the membrane filtration method.
It serves as a rinse buffer in general and can be used for an initial rinse of the filter membrane to inactivate any inhibitors if present.
It serves as a rinse buffer in general and can be used for an initial rinse of the filter membrane to inactivate any inhibitors if present.
Application
Fluid A is a general rinse buffer and is compatible with most test samples. It is suitable for dissolving or diluting the test samples, reconstituting commercial microbes, or as a transport medium for a broad range of microorganisms.
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.
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Storage Class
12 - Non Combustible Liquids
flash_point_f
Not applicable
flash_point_c
Not applicable
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
| SKU | GTIN |
|---|---|
| 1468070006 | 04061838831040 |