HCDC0001L101

Mobius Gold High Cell Density Cryopreservation Assembly

(-80C), 100mL, sterile; γ-irradiated (at 25-40 kGy)

• Synonym(s): Mobius^®Gold High Cell Density Cryopreservation Assembly (-80C), 100 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); 60 mL process volume
• capacity: 100 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

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