Isolator Bag
Description
As the demand for complete sterility increases, forcing isolation technology to become more precise, ATMI LifeSciences designs and manufactures bags that can be sterilized and connected to transfer and glove ports without contamination. Our Ultrapure Cleanconnect™ Isolator Bags are the solution.
Product Design
Manufactured under HEPA filters under cleanroom ISO Class 5 conditions, our bags are custom-designed to customer specifications (single- or double-walled), in shape (sizes of up to 10 ft long are not unusual for the packaging and sterile transfer of plastic components,) in chosen material, and in sterilization techniques (gamma, steam, EtO, Plasma and UV). The bags are connectable to either reusable or single-use isolator connectors currently available on the market. We can heat-seal plastic connectors to our flexible transfer systems and will assist you in all steps necessary to validate your transfer system.
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Application
• Solid components
• Sterile waste
• Sterile liquids
• Transfer of powders
Features
• Single - or double walled bag
• Various materials available:
• Multi-layer, puncture resistant, pinhole-free medical grade PE film bag extruded in a controlled environment, produced in ISO Class 5 environment and available up to level 50 (according to IEST-STD-CC1246D)
• HDPE/Tyvek® bag produced in ISO Class 5 environment and ultraclean to level 200 (according to IEST-STD-CC1246D )
• Available with Easy-Tear opening for easy manipulation and opening without using any cutting device
• FDA approved materials
• Sterilizable by gamma irradiation (25 kGray), steam and EtO (depending on the material)
Benefits
• Reduces the need for expensive and time consuming cleaning processes
• Reduces validation time
• Eliminates traceability issues
• Lowers initial capital investment in comparison to rigid transfer containers, as well as reduced storage place
• Certificate of sterilization delivered with every shipment
• Free of ionic and organic contaminates
• No-additive, PE film free of black points and gels
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