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AssigneeNeuroplast Beheer B.V.
InventorsJohannes Petrus Jozef Maria De Munter, Ekkehard Lang
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The invention relates to the field of clean room facilities for manufacturing of a pharmaceutical product or item according to a sequence of manufacturing steps under extreme low levels of particulates. According to a first aspect of the disclosure a clean room mimicking system is proposed, for example for the manufacturing of a pharmaceutical product or item according to a sequence of manufacturing steps under extreme low levels of particulates, the clean room system at least comprising one clean room facility being composed of multiple air conditioned compartments, each of the multiple air conditioned compartments equipped for performing at least one of the manufacturing steps, wherein the multiple air conditioned compartments are mechanically interconnected and each are constructed in accordance with an associated clean room classification ranging from high to low in terms of the number and size of particulates permitted per volume of air, seen in the direction of the sequence of manufacturing steps through the clean room facility.
A clean room system for the manufacturing of a pharmaceutical product or item according to a sequence of manufacturing steps under extreme low levels of particulates in accordance with internationally standardized classifications of atmospheric cleanliness, the clean room system comprising at least one clean room facility being composed in a modular manner of multiple air conditioned compartments mechanically interconnected, with, during use, the staff personnel operating the clean room facility outside and next to the multiple air conditioned mechanically interconnected compartments forming the clean room facility, each of the multiple air conditioned compartments equipped for performing at least one of the manufacturing steps, wherein the multiple air conditioned compartments are mechanically interconnected by means of intermediate wall elements, each intermediate wall element being provided with an air permeable transfer passage and each of the multiple air conditioned compartments are constructed in accordance with an associated clean room classification decreasing in terms of the number and size of particulates permitted per volume of air, when seen in the direction of the sequence of manufacturing steps through the clean room facility from an air conditioned compartment having a least stringent clean room atmospheric requirement towards an air conditioned compartment having a most stringent clean room atmospheric requirement of the multiple modular interconnected air conditioned compartments.
Dependencies are inferred from the claim text.