XELTA LINR is composed of multi-layer film, with dimensions optimized for NXTbin and other tanks. XELTA LINR is manufactured from premium film with film thickness of 0.25mm. XELTA LINR is validated for use in the biopharmaceutical and pharmaceutical manufacturing processes. XELTA LINR solutions are available in various types and specifications starting from 100L, 200L and 500L.
Compliance: 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.
- 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
The XELTA Mix bags are available in various types and specifications starting from 50L, 100L, 200L, 650L and 1000L and can be used independently for the preparation of buffer, media, intermediate or drug substance mixing.
NXTmix is the next-generation levitation-based mixing technology designed to handle all your single-use mixing requirements from media & buffer preparation, intermediate process mixing, final formulation and filling application. Highly flexible and cGMP complaint system allows you to use volumes commonly used in manufacturing processes of up to 1000L. The NXTmix system incorporates levitation technology for a single-use mixing system fitted into either a plastic tote with a trolley or stainless steel tanks. NXTmix offers complete flexibility with options to customize, providing users with easy mixing of powder-liquid or liquid-liquid applications.
NXTbin is a stainless steel cylindrical vessel designed to safely and robustly store pharmaceutical or biopharmaceutical fluids using XELTA 3D single-use bags. This unit has a wide range of bag sizes, making it suitable for many applications. NXTbin units are available in three volumes: 100L, 200L, and 500L. NXTbin is available in a jacket option as well for temperature-sensitive applications.