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CTO Single-Use 3D Bag with Ports Only

In stock
Part No. B3D50LX4NNA1
$112.00 USD
Volume
Number of Ports
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*Ships within 2 Weeks
*Customers are responsible for any import duties or taxes
*Read our Shipping Policy and Refund Policy
*Not for medical use

Configuration-to-order (CTO) products provide a good solution between off-the-shelf products and fully custom systems.

Cobetter CTO 3D single-use bioprocess bags with ports are used for buffer and media storage and transfer, accommodating volumes ranging from 50L to 3000L. The 3D single-use bag can be heat-sealed with 0-4 dimple barb or opposable barb. Port sizes available from 1/8'' HB to 1'' HB. 

Features

  • Flexible customized solutions
  • Good physical strength and great biological safety with Topene™ RB film
  • Fast lead time, fully self-produced components 

Topene™ Film

Cobetter Topene RB blown film designed for biological processes is composed of ULDPE (ultra-low density polyethylene), EVA (ethylene-acetic acid ethylene copolymer), EVOH (ethylene-vinyl alcohol copolymer) and LDPE (low density polyethylene).

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • ISO 4.8 / ISO 7 / ISO 8 cleanroom production
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • COA/COQ provided with shipment
  • Validation documents are available upon request
  • TSE/BSE certificate available
Physical Properties Product Name Lifecube™ 3D Storage & Shipping Bag
Bag Volume 50 L/ 100 L/ 200 L/ 250 L/ 500 L/ 650 L/ 1000 L/ 1500 L/ 2000 L/ 2500 L/ 3000 L
Materials Film Material Topene™ RB film
Connections Available Port Type

Disc Barbed Bag Port

Opposing-Barb Disc Bag Port
Available Port Size 4 Ports available in 1/8" HB, 1/4" HB, 3/8" HB, 1/2" HB, 3/4" HB, 1" HB
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Sterility Delivery Condition Non-sterile
Sterilization Option Can be sterilized by gamma irradiation at 25-45 kGy
Package Pack Size Pack of 1
Packaging Individually packed in double PE bag

 
What are the specifications of Cobetter single-use storage bioprocess bags? What is the maximum storage volume?

Cobetter 2D single-use bioprocess bags are available in 250mL, 500mL, 1L, 2L, 5L, 10L, 20L, 35L, 50L.

3D single-use bioprocess bags are available in 20L, 50L, 100L, 200L, 500L, 1000L, 1500L, 2000L.

Generally, the maximum storage volume for the storage bioprocess bag is 110% of the nominal volume.

What are the applicable conditions for the use of single-use storage bioprocess bags?

Cobetter single-use storage bioprocess bags are used for Liquid collection, storage, transport, and liquid sampling during the production process, such as media storage, buffer storage, collection of filtered liquids, buffer filling, and so on.

The recommended temperature range is -80°C to 60°C, pH range is 2.5-11.

What ISO cleanroom classifications apply to the manufacturing of Cobetter single-use bags?

Cobetter operates one ISO Class 5 manufacturing line dedicated to the production of filling system–related products. In addition, Cobetter is equipped with eleven ISO Class 7 and ISO Class 8 production lines for the manufacture of single-use storage bags, mixing bags, and customized tubing assemblies.

What tests are typically performed on Cobetter single-use bags prior to release?

A Certificate of Quality is provided with each shipment, listing routine test items and applicable reference standards. These tests include bag integrity, endotoxin levels, sterility, and insoluble particulate matter, among others.

How should single-use storage bioprocess bags be transported?

Generally, single-use bioprocess bags with a capacity of 20L or less can be hung or carried by hand for transportation. However, for bags larger than 20L, it is recommended to place them on pallets or flatbed carts for transferring.