Quality Level
material
glass bottle
agency
EP 2.6.1, JP 4.06, USP 71
71
sterility
sterile; autoclaved
form
liquid
shelf life
360 days
feature
closure type Blue screw cap with 3 septa, ready-to-use
composition
Tween® 80, 3.3% (33 mL)
packaging
pack of 6 bottles
concentration
3.3%
technique(s)
direct inoculation: suitable
bottle capacity
1000 mL
bottle filling volume
1000 mL
pH
6.5-7.5
application(s)
cosmetics
food and beverages
pharmaceutical
sterility testing
storage temp.
2-25°C
suitability
nonselective for
General description
Tween 80 3.3% is a washing solution of pharmaceutical samples containing lecithin or oil using the membrane filtration method
Application
Tween 80 3.3% 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 are 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.
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.
存储类别
10 - Combustible liquids
wgk
WGK 1
法规信息
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全球贸易项目编号
| 货号 | GTIN |
|---|---|
| 1466500006 | 04054839382673 |