Mobius® 2D Freeze Assembly by Merck – Secure Frozen Liquid Storage & Transport for Pharma & Biopharma
Pharmaceutical manufacturing demands safe and reliable solutions for the frozen storage and transportation of bulk drug substances. The Mobius 2D Freeze Assembly by Merck is a single-use freeze-thaw bag system constructed from high-purity PureFlex™ film and helium-tested for micro-integrity, ensuring product safety at temperatures as low as -80 °C. Designed for use in single-use bioprocessing workflows, this advanced assembly supports regulatory compliance and process flexibility across pharma and biopharma operations.
Discover how this advanced single-use assembly supports compliance and process flexibility.
Key Benefits & Features of Mobius® 2D Freeze Assembly
Performance & Integrity
- Reliable product protection at ultra-low temperatures: Integrity is assured at temperatures down to -80 °C throughout the entire freeze, storage, transportation, and thaw cycle.
- 100% helium integrity testing: Every assembly is individually tested, detecting defects as small as 2 µm across the entire assembly, including tubing and connection points.
- Compliance-ready quality standards: Gold Certification with gamma irradiation sterilization (25–40 kGy) and testing against USP <85>, <88>, <661>, and <788> standards supports regulatory compliance in pharmaceutical manufacturing.
Process Flexibility & Scalability
- Four available bag sizes: 1 L, 5 L, 10 L, and 20 L, accommodating both lab-scale and large-scale bulk drug substance operations.
- Safe multi-site transfers: When secured within a compatible RoSS® shell from Single Use Support GmbH, the assembly enables flexible and protected product transfers between multiple manufacturing sites.
- Reduced validation burden: PureFlex™ film — a high-purity, medical-grade, coextruded film — can be qualified once across multiple process steps, streamlining implementation.
- Two-year shelf life: Supports inventory planning and reduces the risk of product expiry in storage.
Assembly Configuration
- Port Configuration (1 L): End-ported design with 2 ports; AseptiQuik® S connector (1/8 in. HB); Pharma 65 tubing (3 mm ID × 6 mm OD).
- Port Configuration (5 L, 10 L, 20 L): Boat-ported design with 3 ports; Lynx® S2S male and female connector (3/8 in. HB) or AseptiQuik® G connector (3/8 in. HB); C-Flex® 374 tubing (1/4 in. ID × 1/2 in. OD and 3/8 in. ID × 5/8 in. OD).
- Disconnect Mechanism: NovaSeal™ pinch pipe across all sizes.
Technical Specifications of Mobius® 2D Freeze Assembly
| Parameter | 1 L | 5 L | 10 L | 20 L |
|---|---|---|---|---|
| Maximum Filling Volume | 0.9 – 1.0 L | 3.7 – 4.0 L | 7.2 – 7.4 L | 11.7 – 12.2 L |
| Bag Dimensions | 6 in. W × 12.3 in. H | 12.5 in. W × 12 in. H | 11.5 in. W × 21.75 in. H | 16.5 in. W × 23 in. H |
| Operating Temperature (inside RoSS® shell) | -80 °C to 60 °C (-112 °F to 140 °F) | |||
| Certification Level | Gold Certification with Helium Integrity Testing | |||
| Shelf Life | 2 Years | |||
| Integrity Testing | 100% assembly integrity tested using helium as a tracer gas; detects defects down to 2 µm | |||
| Sterility | Sterilized using a validated gamma irradiation level of 25–40 kGy | |||
| Quality Testing Standards | USP <85> Endotoxins; USP <788> Subvisible Particulates; USP <88> Biological Reactivity in vivo (Class VI); USP <661> Physicochemical Tests; Bioburden; Bacteriastasis/Fungistasis — all tested post-gamma irradiation (1 assembly per lot) | |||
| Film | PureFlex™ film with hanger and support rod | |||
| Tubing | Pharma 65 (3 mm ID × 6 mm OD) | C-Flex® 374 (1/4 in. ID × 1/2 in. OD); C-Flex® 374 (3/8 in. ID × 5/8 in. OD) | ||
| Port Configuration | End-ported, 2 ports | Boat-ported, 3 ports | ||
| Connectors | AseptiQuik® S (1/8 in. HB) | Lynx® S2S male and female (3/8 in. HB) or AseptiQuik® G (3/8 in. HB) | ||
| Disconnect | NovaSeal™ pinch pipe for 3 mm ID × 6 mm OD tubing | NovaSeal™ pinch pipe for 3/8 in. ID × 5/8 in. OD tubing | ||
| Compatible RoSS® Shell Part Number | RoSS_1043 | RoSS_1042 | RoSS_1022 | RoSS_1040 |
| Compatible RoSS® Shell Dimensions | 183 × 462.6 × 41.6 mm (7.2 × 18.2 × 1.6 in.) | 333 × 490 × 70 mm (13.1 × 19.3 × 2.8 in.) | 303 × 712 × 70 mm (11.9 × 28 × 2.8 in.) | 460 × 823.6 × 69.6 mm (18.1 × 32.4 × 2.7 in.) |
Applications of Mobius® 2D Freeze Assembly
- Bulk Drug Substance Freeze, Storage, and Transport: The Mobius® 2D Freeze Assembly is used for the freezing, storage, transportation, and thawing of bulk drug substances and biopharmaceutical products, supporting safe multi-site transfers when secured within RoSS® shells.
- Single-Use Bioprocessing Workflows: As a fully single-use freeze-thaw bag system, it eliminates cross-contamination risk and reduces cleaning validation requirements in GMP manufacturing environments.
- Scale-Up and Tech Transfer: With volumes from 1 L to 20 L, the assembly supports process development, clinical manufacturing, and commercial-scale bulk drug substance handling across multiple sites.
Mobius® 2D Freeze Assembly Product Portfolio
| Mobius® Bag Size | Catalogue Number | Description |
|---|---|---|
| 1 L | FRZ0001L001P5 | Mobius® bag, Gold w/Helium IT, 1 L STD PureFlex™ film with AseptiQuik® S connectors |
| 5 L | FRZ0005L001P5 | Mobius® bag, Gold w/Helium IT, 5 L STD PureFlex™ film with AseptiQuik® G connectors |
| 5 L | FRZ0005L002P5 | Mobius® bag, Gold w/Helium IT, 5 L STD PureFlex™ film with Lynx® S2S connectors |
| 10 L | FRZ0010L001P5 | Mobius® bag, Gold w/Helium IT, 10 L STD PureFlex™ film with AseptiQuik® G connectors |
| 10 L | FRZ0010L002P5 | Mobius® bag, Gold w/Helium IT, 10 L STD PureFlex™ film with Lynx® S2S connectors |
| 20 L | FRZ0020L001P5 | Mobius® bag, Gold w/Helium IT, 20 L STD PureFlex™ film with AseptiQuik® G connectors |
| 20 L | FRZ0020L002P5 | Mobius® bag, Gold w/Helium IT, 20 L STD PureFlex™ film with Lynx® S2S connectors |
Chemical Express is the official Merck distributor in Thailand, with over 23 years of experience supporting pharmaceutical and biopharma laboratories. Contact us to source Mobius® 2D Freeze Assemblies and related Merck single-use bioprocessing products with local technical support and reliable supply.
Get Expert Support or Request a Quote for Mobius® 2D Freeze Assembly
Simply fill out our Inquiry Form or chat with us instantly on Line using the buttons below.
We’re here to help!
English 
Thai