We Offer Comparable Replacements
Compatible in systems that use Aramus 2D bags
Our 2D single-use bags are designed for the safe storage and transfer of critical process fluids and final products. Available in a range of sizes, port configurations, and assembly options, they integrate easily into both existing and new manufacturing processes. Whether you need a replacement for an unavailable product or a custom solution for a new application, we work with you to deliver bags that meet your process, performance, and manufacturing requirements.
Custom manifolding enables process efficiency in any application.
2D single-use bags are available with lead times that keep the line running.
Our single use bags are built to integrate into your current process.
We are a U.S. based manufacturer committed to this market for the long term.
We can support deviations, change control plans and qualification work.
Size, geometry, port count, connectors, and tubing are specified to your process rather than selected from a catalog. The assembly fits the shells, cassettes, and racks you already run, so your hardware does not change.
No laminate to delaminate at cryogenic temperature, and no adhesives, binders, or curing agents in the fluid path. FEP is chemically inert across the solvents and formulation components used in cryopreservation.
Our manufacturing process was developed so that seal formation does not shed particulate into the product.
Materials selected for very low glass transition temperature, so integrity holds through long term cryogenic storage rather than surviving only the initial freeze. Post cryogenic seal integrity and visual inspection are qualified to ASTM F3039 and F1886.
Biological reactivity, sub-visible particulate, bacterial endotoxin, and extractables are qualified to USP 87, 788, 85, and 661.2 on post sterilization articles. Results and margins are in the Evidence Summary.
Sterilization is performed both in house and through qualified partners, all within our ISO 13485 scope. Qualified under ISO 11135 with residuals evaluated against implantable device limits under ISO 10993-7. Running both routes protects schedule and capacity without moving product outside our quality system.
Production, inspection, kitting, packaging, and sterilization all occur in Class 6 space certified to ISO 14644-1 by an accredited body. Product reaches your controlled environment with outer layers removed at each stage.
Sterile barrier shelf life established by accelerated and real time aging. Distribution simulation to ASTM D4169 and ISTA 2A.
Complete traceability from component level to finished assembly and in reverse. Laser marking of lot identification directly onto the bag is available where your process requires it.
We commit in advance and in writing to notify you of changes to materials, design, sterilization, packaging, manufacturing site, regulatory status, or discontinuation of a product line. Three certified US sites and a monthly certified inventory position stand behind it.
CryoLoc™ CTF bag assemblies are built to order, from 4 mL to 50 L. Port count, connector type, and tubing configuration are specified to your process. Options include male and female luers, swabable valves, spike ports, capped ends, and weldable sealed ends for closed system transfer, along with pinch clamps and tubing sets matched to what you run today.
Our Cleanroom-to-Cleanroom™ model ensures that products remain in a sterile environment from production to delivery. Manufactured and packaged within our Class 6 Cleanroom, each product is encapsulated in specialized packaging that maintains this pristine environment so that when you open it in your cleanroom, the product is just as clean and safe as when it left our facility.
Our dedicated team of experts is available to provide technical support and guidance, ensuring you choose the right product for your application.
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