The XELTA 2D bags have been designed for crucial applications where systems are required to be reliable, flexible, and easy to install. Manufactured from premium film and with a film thickness of 0.325mm the XELTA 2D bags are validated for use in the biopharmaceutical and pharmaceutical manufacturing processes. The XELTA 2D bags bring together state-of-the-art design features that improve the robustness of single-use systems. This brings considerable advantages in terms of ease of use and product recovery when dealing with biopharmaceutical fluids.

The XELTA 2D bags are designed to meet the demands of crucial applications in the biopharmaceutical and pharmaceutical industries. These bags are reliable, flexible, and easy to install, offering advantages in terms of product recovery and ease of use. Manufactured from premium film with a thickness of 0.325mm, the XELTA 2D bags are validated for use in manufacturing processes. They are available in a wide range of sizes and are suitable for various applications such as storage, transport, and filtering of biopharmaceutical fluids. The bags can be customized with connectors, tubing, and clamps to meet specific process requirements. Manufactured in accordance with ISO 9001:2015 certified quality management systems and cGMP requirements, the XELTA 2D bags undergo extensive testing to ensure compliance with pharmacopoeial standards and bio-compatibility. The specialized film used in these bags provides good resistance to chemicals and polar solvents, with favorable properties such as clarity, tensile strength, and gas permeability.

 

The XELTA 2D bags offer users the flexibility to order a wide range of configurations. You can choose from a diverse selection of connectors, tubing, clamps, and other components from any supplier to customize the bags according to your specific process requirements.

Our XELTA 2D bags are meticulously designed, developed, and manufactured in strict adherence to an ISO 9001:2015 certified Quality Management System. Prior to shipping, these bags undergo rigorous testing to ensure their quality and reliability. We take great care to manufacture our products in compliance with cGMP requirements, making them suitable for cleanroom processes.

 

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TECHNICAL INFORMATION

The XELTA 2D bags are designed to meet the demands of crucial applications in the biopharmaceutical and pharmaceutical industries. These bags are reliable, flexible, and easy to install, offering advantages in terms of product recovery and ease of use. Manufactured from premium film with a thickness of 0.325mm, the XELTA 2D bags are validated for use in manufacturing processes. They are available in a wide range of sizes and are suitable for various applications such as storage, transport, and filtering of biopharmaceutical fluids. The bags can be customized with connectors, tubing, and clamps to meet specific process requirements. Manufactured in accordance with ISO 9001:2015 certified quality management systems and cGMP requirements, the XELTA 2D bags undergo extensive testing to ensure compliance with pharmacopoeial standards and bio-compatibility. The specialized film used in these bags provides good resistance to chemicals and polar solvents, with favorable properties such as clarity, tensile strength, and gas permeability.

The XELTA 2D bags offer users the flexibility to order a wide range of configurations. You can choose from a diverse selection of connectors, tubing, clamps, and other components from any supplier to customize the bags according to your specific process requirements.

Our XELTA 2D bags are meticulously designed, developed, and manufactured in strict adherence to an ISO 9001:2015 certified Quality Management System. Prior to shipping, these bags undergo rigorous testing to ensure their quality and reliability. We take great care to manufacture our products in compliance with cGMP requirements, making them suitable for cleanroom processes.

1) Compliance:
The following tests are conducted for Pharmacopoeial compliance and Bio-compatibility.

USP <85> Bacterial Endotoxins – LAL test

USP <87> Biological Reactivity Test in-vitro

USP <88> Biological reactivity testing, in-vivo, Class VI European Pharmacopoeia tests 3.1.5

USP <661.1> Polyethylene Physicochemical Tests, Extractable Metals, Plastic Additives

2) Film Properties
The film used in XELTA 2D bags is specialized for biopharmaceutical and pharmaceutical
processes.
The thickness of the film is 0.325mm

The recommended sterilization method is Gamma Irradiation. The dose for gamma sterilization is 25-50 KGy

Good resistance to a wide range of Pharmaceutical and Biopharmaceutical grade chemicals

Good resistance to polar solvents (alcohols, esters, etc)

Water pH compatibility is 2.5 to 11.

Clarity – ASTM D-1003

Tensile Strength at break – ASTM D-882 

O2 permeability – ASTM D-3985

CO2 permeability – ASTM F-2476

 

 

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