Sterile Single-Use storage bags 2D-3D from JYSS BIO

The bags are preferably made with Renolit 9101 film.

However, in the event of a sustained supply issue with this film, it can be replaced, with your agreement, by JYSS BIO EB1596 film, which has the same certificates of conformity but is less well-known to European customers.

This ensures the continuity of your business. The EB1596 multilayer film, developed by JYSS BIO for biopharmaceutical applications, is the first 9-layer co-extruded film on the market. It meets the requirements of the European, American, and Chinese pharmacopoeias, as well as national and international standards and industry standards.

The films are primarily composed of PE, PA, and EVOH; they offer various properties such as abrasion resistance, adhesion, gas barrier properties, and tensile strength. Because the liquid-contacting layer is composed of inert materials, the films exhibit good tensile strength, puncture resistance, and heat-sealing resistance, as well as satisfactory levels of extractables and releasers (E&L).

The film is designed to combine:

• mechanical strength;

• flexibility;

• puncture resistance;

• barrier properties;

• compatibility with biological fluids;

• suitability for cell culture applications;

• maintenance of integrity during storage and transfer.

The EB1596 film is also used by JYSS BIO for its culture bags, mixing bags, and single-use assemblies.

Biocompatibility and Extractables

The Renolit 9101 and EB1596 films have undergone physicochemical and biocompatibility testing. They comply with USP 661, 665, 85, 87, 88 and ISO 10993.

E&L documentation is available upon request. Extractables and Leachables (E&L) testing is performed by the Swiss General Surveillance Company (SGS).

• Tubing: Platinum-vulcanized silicone tubing, TPE tubing, PVC tubing

• Standard lines: Inlet, outlet, sampling

• Connectors: Quick connector, Y-splitter, T-splitter, cross joint, reducer, TC connector, sampling connector, Luer

• Components: Sterile connector, sterilizing filter

2D bags are made of welded film sheets that form a flat container when empty.

They are particularly well-suited for small to medium volumes and for operations requiring frequent handling.

Common applications:

• Storage of media and buffers;

• Preparation of feeding solutions;

• Feeding a bioreactor;

• Harvest recovery;

• Collection of intermediate products;

• Sampling;

• Distribution to multiple pieces of equipment;

• Temporary storage before filtration;

• Packaging of small batches.

Their compact size when empty facilitates the storage of consumables and their transport to the workstation.

2D bags can be used flat, suspended, or placed in a protective tray, depending on their volume and configuration.

3D bags are designed to be deployed in a rigid container, bin, or trolley.

They are intended for larger volumes and for storage or transfer operations carried out in pilot plants or production environments.

Common applications:

• Storage of large volumes of media;

• Storage of buffer solutions;

• Bioreactor collection;

• Collection of intermediate products;

• Feeding for a clarification operation;

• Storage prior to chromatography or ultrafiltration;

• Transfer between two production areas;

• Internal transport of biopharmaceutical fluids.

The outer container supports the weight of the liquid and protects the bag during filling, storage, and transport.

Trolleys and transport systems can be used with high-capacity bags.

Choose a 2D bag when:

• the volume is small or medium;

• the bag must remain easy to handle;

• the operation involves a one-time supply, sampling, or transfer;

• available storage space is limited;

• the bag must be suspended or installed in a small container.

Choose a 3D bag when:

• the volume becomes significant;

• the liquid must be stored in a rigid container;

• the bag must remain stable during filling;

• the installation requires a transport trolley;

• the fluid must supply a pilot or industrial stage.

Blanc-Labo helps you verify the actual usable volume, the container geometry, and the position of the connections.

A storage SU Bag can integrate several lines and components.

Tubing available

Depending on the application, JYSS BIO offers:

• platinum vulcanized silicone tubing;

• weldable thermoplastic tubing;

• PVC tubing;

• other tubing selected according to process compatibility.

Available lines

The standard configuration may include:

• an input line;

• an output line;

• a sampling line;

• a vent line;

• a filling line;

• a drain line.

Fittings and accessories

Assemblies can include:

• quick connectors;

• Y fittings;

• T-fittings;

• cross connections;

• discounts;

• Tri-Clamp sanitary fittings;

• Luer fittings;

• sampling ports;

• sterile connectors;

• sterilizing filters;

• vent filters;

• clamps;

• end caps and protections.

The choice of components depends on the diameter of the lines, the flow rate, the pressure and the interfaces present on your installation.