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(this section is available only in english)
The MPI isolator allows the hospital pharmacy to produce sterile finished forms without
contamination risk.
The MPI isolator is bio-decontaminated with vaporized hydrogen peroxide (106 spores log
reductions) and is fully equipped with control and recording probes (temperature, pressure,
relative humidity), particle counting and microbiological monitoring devices.
The inside of the working chambers is made off stainless steel AISI 316 L, mirror polished.
A laminar air flow maintains the GMP class A conditions and a positive pressure (>60 Pa) protects
the internal environment from potential external contaminations.
To allow multi-batch productions, a special egress pass box is in place, so that the finished
products can leave the isolator without compromising the sterility of the inside.
Moreover the MPI isolator is fully qualified (IQ/OQ) and process could be validated to document
the evidence of its total compliance to the current GMP requirements.
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