HCDC0001L102

Mobius Gold High Cell Density Cryopreservation Assembly

(-80C), 250 mL, sterile; γ-irradiated (at 25-40 kGy)

• Synonym(s): Mobius^® Gold High Cell Density Cryopreservation Assembly (-80C), 250 mL
• UNSPSC Code: 41103801

Properties

• material: device (thermoplastic elastomer); polyethylene device; polypropylene device; silicone device
• Quality Level: 400
• 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)
• product line: Mobius^®
• parameter: -80-60 °C temp. range (-112-140 °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

Description

General description

Device configuration: 5 bags per assembly

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.

Our Mobius^® High Cell Density Cryopreservation (HCDC) Assembly (-80°C) is a single-use assembly specially designed to facilitate the freeze and thaw of cryopreserved cells at -80°C. Available in two assembly bag sizes of 100 mL and 250 mL, our Mobius^® HCDC Assembly (-80°C) 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.

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

Five (5) assembies per package with each assembly containing five (5) 250 mL cryo bags

Components

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

Polyethylene bags: Pureflex FilmTubing: Silicone and Thermoplastic ElastomerFittings: PolypropyleneNovaSeal Pinch Pipes: Nickel plated brassPinch 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.

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