certified by the (Assembly performed under ISO Clean Room Class 7 conditions in a facility) certified by the ISO (Bags manufactured under ISO Clean Room Class 8 conditions in a facility)
sterility
sterile; γ-irradiated (level of 25-40 kGY)
product line
Mobius® Freeze
packaging
package of 5 ×
parameter
-80-60 °C temp. range (112-140 °F) 1 L process volume
The Mobius® 2D freeze single-use assembly offers a robust freeze and thaw solution that allows safe storage and transportation of your valuable product at a very low temperature while maintaining the integrity of the final product. Combined with the RoSS® (Robust Storage and Shipping) shell, this solution enables easy and safe bulk drug substance and product transfer between multiple sites providing flexibility and security to your processes. Available in 1L, 5L, 10L, and 20L sizes, this standard 2D Freeze assembly is made with our PureFlex™ film and is tested for use at temperatures down to - 80 °C during, freezing, storage, transportation, and thawing.
Application
Freeze/Thaw Applications
Protect and Freeze Your Bulk Drug Substance
Packaging
Five (5) assembies per package with each assembly containing five (5) 1L bags
Components
PureFlex™ filmPharma 65 tubingAseptiQuik S connector NovaSeal pinch pipe
Other Notes
• Mobius® 2D Freeze Assemblies are intended to be used solely with Single Use Support RoSS® shells.• User shall be solely responsible and liable for validation and use of the Mobius® bag assemblies beyond the range of our specifications.• Carefully handle the Mobius® assembly at all times.• Do not handle the Mobius assembly until completely thawed.
Legal Information
AseptiQuik is a registered trademark of Colder Products Company
MOBIUS is a registered trademark of Merck KGaA, Darmstadt, Germany
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany
Ross is a registered trademark of Thermo Electron Corp.
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