Single Use Systems

mdi offers a wide range of gamma irradiated Single Use Systems for various critical applications in biopharmaceuticals and pharmaceuticals. These range from simple storage and transfer systems for media, buffers and drug substances; and sampling manifolds for bioreactors and process intermediate reservoirs; to more complex disposable filling lines complete with separate tubing connections for integrity testing and drain bags for collection of wetting fluids. mdi Single Use Systems are custom designed, in close interaction with the user, to maximize regulatory compliance and process efficiency. All the key components used in these SUS are produced in house which are deeply characterized and validated for integrity, microbial retention/ingress, sterility, bacterial endotoxins, biosafety and extractables.

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Product Realization

mdi works closely with the process owners to understand their application requirements in terms of working environment, volume range, temperature conditions, fluid pressure, size and number of connections, transfer lengths, sampling needs, chemical compatibility etc. Subsequently technical feasibility of the system is established based on available single use components and to propose an initial SUS drawing. Product prototyping and final approval lead to customized product realization.