Freeze Bag Assemblies
Brand: Aramus™
Our Freeze Bag Assemblies are the only gamma-sterilizable bags made of fluoropolymer material worldwide. These fluoropolymer bags are comparable to Teflon® and are unique for their working temperature and chemical resistances. Pre-sterilized assemblies are mostly used in frozen applications, for example freezing of drug substance or intermediates at -85°C.
Features
Benefits
- Ideal for frozen applications from -85°C to 40°C, maintaining flexibility even in liquid nitrogen.
- Made from a single fluoropolymer without additives like plasticizers or colorants, ensuring a superior leachables and extractables profile. BPOG-compliant test data available upon request.
- Highly durable with no risk of delamination.
- Monolayer coating.
- Sterilizable.
- Produced in an ISO Class 5 cleanroom, reducing endotoxins and particle contamination.
Applications
- Downstream processes
- Freezing cell cultures and intermediates
- Storage and transport of active ingredients
- Freezing and storage of stem cells
- Storage and transport of aggressive media
- Storage and transport of binding media
- Filling
- Critical sampling
Specifications
Temperature Range | : | -85°C to 40°C |
Sterilizable | : | Yes |
Bag Volumes / Sizes | : | 50 ml / L120 x W100 mm |
: | 100 ml / L160 x W100 mm | |
: | 250 ml / L240 x W100 mm | |
: | 500 ml / L210 x W158 mm | |
: | 1 L / L285 x W178 mm | |
: | 2 L / L354 x W254 mm | |
: | 5 L / L470 x W323 mm | |
: | 10 L / L570 x W383 mm | |
Bag Material | : | Single fluoropolymer without additives |
Tube Materials | : | Platinum-cured silicone |
: | C-flex® tubing, formulation 374 | |
Tube Length | : | 6″ (for bag volumes 50 ml to 250 ml) |
: | 12″ (for all bag volumes) | |
: | 18″ (for bag volumes 500 ml to 20 L) | |
: | 24″ (for bag volumes 500 ml to 20 L) | |
Main Connectors | : | Luer (for bag volumes 50 ml to 250 ml) |
: | MPC (for bag volumes 500 ml to 20 L) | |
Sample Connector | : | Luer (for bag volumes 500 ml to 20 L) |
Fasteners | : | Stainless steel ear clamps |
: | BarbLock® clamps |
Note: 20mL and 50L Aramus™ bags available on request.
Compliance
- USP Class VI
- USP <87> (Biological Reactivity)
- USP <88> (Biological Reactivity Testing In Vivo)
- USP <85> and EP 2.6.14 (<0.125 EU/ml)
- ISO 10993-4 (Non-Hemolytic)
- USP <661> (Extractables)
- USP <788> and EP 2.9.19 (Particulate Matter)
- BSE/TSE Certification