FRZ0001L001P5

Mobius^® Gold 2D Freeze Assembly w/Helium IT

1L PureFlex^™ film with AseptiQuik^® S connectors

• Synonym(s): Mobius^®, Gold w/Helium IT, 1L PF FRZ TRN Assy w/ ASPQ S

Properties

• material: PureFlex^™ device (film); connections (AseptiQuik S connector); tubing (Pharma 65)
• Quality Level: 400
• Agency: 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

Description

General description

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.