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Safety Information

HCDC0001L0250

Mobius Gold High Cell Density Cryopreservation Assembly

(-196C), 250 mL, sterile; y-irradiated (at 25-40 kGy)

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UNSPSC Code:
41103801

material

(flouropolymer)
(thermoplastic elastomer)
device
polypropylene
silicone (thermoplastic elastomer)

Quality Level

Agency

according to ISO 11137
meets EN 2.6.14
meets JP 4.01
meets USP 85

sterility

sterile; γ-irradiated (at 25-40 kGy)

parameter

-196- 60 °C temp. range (-321- 140 °F)
0.3 bar max. pressure (4.4 psi)
150 mL process volume

capacity

250 mL

impurities

<0.25 EU/mL Aqueous extraction (LAL test)

application(s)

mAb

storage temp.

2-30°C

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General description

Device configuration: 5 bags per assembly
Our Mobius® High Cell Density Cryopreservation (HCDC) Assembly (-196C) is a single-use assembly specially designed to facilitate the freeze and thaw of cryopreserved cells in liquid nitrogen vapor phase (? -196°C). Available in two assembly bag sizes of 100 mL and 250 mL, our Mobius® HCDC Assembly (-196C) enables seed train inoculation with cells at a higher cell density and larger volume compared to the traditional seed train process using vials, which significantly accelerates the cell expansion process. Our Mobius® single-use assembly also provides a closed processing environment preventing contamination while improving process reproducibility.

Specificity

All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo.
Application

Application

Croyopreserved storage of cells

Packaging

Five (5) assembies per package with each assembly containing five (5) 100 mL cryo bags

Components

Fluoropolymer bags: Tubing: Silicone and Thermoplastic ElastomerFittings: PolypropyleneNovaSeal Pinch Pipes: Nickel plated brass
Pinch clamp: Nylon

Other Notes

Bags manufactured under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 standards. Assembly performed under ISO Clean Room Class 7 conditions in a facility certified to ISO 14644-1 standards.

Legal Information

MOBIUS is a registered trademark of Merck KGaA, Darmstadt, Germany

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Regulatory Information

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Certificates of Analysis (COA)

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Articles

High cell density cryopreservation (HCDC) is a closed processing alternative to the traditional seed train expansion process. Learn more about the benefits of HCDC.

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