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Merck
CN

FRZ0001L001P5

Mobius® Gold 2D Freeze Assembly w/Helium IT

1L PureFlex™ film with AseptiQuik® S connectors

别名:

Mobius®, Gold w/Helium IT, 1L PF FRZ TRN Assy w/ ASPQ S

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UNSPSC Code:
23151806

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material

PureFlex™ device (film), connections (AseptiQuik S connector), tubing (Pharma 65)

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

technique(s)

buffer exchange: suitable, media fill: suitable

fitting

connector (AseptiQuik S 1/8”HB), (end-ported (2 X 1/8"))

application(s)

cell therapy
gene therapy
life science and biopharma
liquid processing
mAb
ophthalmics
parenterals
pharma/biopharma processes
viral therapy
waste management

Quality Level

400

storage temp.

10-30°C

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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

Features and Benefits

Standard products eliminate design and manufacturing lead times.
Utilizes PureFlex™ Film and components that can easily scale up.

Packaging

Five (5) assembies per package with each assembly containing five (5) 1L bags

Other Notes

PureFlex™ filmPharma 65 tubingAseptiQuik S connector NovaSeal pinch pipe
• 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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Bioprocess Considerations for Manufacturing Allogeneic Cell Therapies

This article explains how to streamline transfer of an allogeneic cell therapies process to a CDMO partner and long-term manufacturing success.

Building Regional Single-Use Supply Chains

Our global network of raw material suppliers and regional production sites for single-use technologies ensures business continuity for biopharma customers.

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