XELTA LINR is a premium multi-layer film solution designed for biopharmaceutical and pharmaceutical manufacturing. With optimized dimensions for NXTbin and other tanks, it ensures efficient fluid storage. Validated and manufactured under cGMP conditions, XELTA LINR eliminates post-cleaning steps, reduces cross-contamination risks, and saves material costs. It maximizes space utilization, increases operational efficiency, and facilitates the hydration of powdered media and buffers. A reliable and versatile choice for fluid storage, XELTA LINR enhances productivity in critical processes.
Manufactured in an ISO7 environment under cGMP conditions and gamma irradiated, ensuring minimal bioburden risks.
Eliminates the need for post-cleaning steps, reducing cross-contamination risks.
Efficient space utilization compared to reusable systems that require separate storage areas for soiled and clean containers.
Cost savings by eliminating the need for CIP (Clean-in-Place) and SIP (Sterilize-in-Place) processes.
Improved operational efficiency with shorter cycle times and reduced manpower requirements.
Facilitates easy hydration of powdered media and buffers, enhancing process convenience and productivity.
The following tests are conducted for Pharmacopoeia 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 Physiochemical Tests, Extractable Metals, Plastic Additives
The film used in XELTA LINR is specialized for biopharmaceutical and pharmaceutical processes.
The thickness of the film is 0.25mm
The recommended sterilization method is Gamma Irradiation. The dose for gamma sterilization is 25-50 KGy
Good resistance to many chemicals
Good resistance to polar solvents (alcohols, esters, etc)
Water pH = 2.5 to 11 compatible