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Multi-layer Biocontainers for Aseptic Fluid Management

SpecialChem / Apr 15, 2010

In an effort to reduce cleaning & validation efforts, minimize turnaround time & risk of cross-contamination, and make the fluid management process simple & less time consuming, Meissner has recently introduced ‘Flexistation’ transport and shipping containers. The product belongs to the One-Touch single-use systems family and uses a USP Class VI film.


Made of five-layered polyolefin-based TepoFlex film with great visual clarity, its chamber provides extractables & leachables profiles, water vapor & oxygen barriers, and fluid integrity to mitigate the risk of product degradation. These assembled sterile biocontainers are connected with either thermoplastic elastomers (TPE) or platinum-cured silicone customized tubing. SteriLUX PVDF (polyvinylidene fluoride) / EverLUX PES (polyethersulfone) / StyLUX PES filters are used in the 3D biocontainers that are compatible with its rigid external containers, called Flexstation. In this system, one can easily trace the whole process of fluid moving within the assembly. These biocontainers come in four shapes: 2D end-ported, 2D face-ported, 3D top-ported and 3D top & bottom-ported. Tepoflex was tested on seven different fluids - WFI, PBS (pH3), PBS (pH11), 3M sodium chloride in WFI, 96% ethanol, one percent Tween 80 in WFI and 10% DMSO in WFI - wherein gamma was irradiated at a dosage of 30kGy (kilo grey). Biocontainers were filled with respective model extraction fluids and incubated at a certain volume ratio for three months at 40°C & 75%RH.

  • Hold/store/shipping products, like media, buffers, water for injection (WFI), reagents, etc
  • Media & buffer preparation; formulation of drug products
  • Cell culture/fermentation
  • Bioreactor and process sampling
  • Microfiltration/purification/ultrafiltration
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