MODULAR, SELF-CONTAINED, MOBILE CLEAN ROOM

摘要

Biosafety units, methods of making, and sealing the same are disclosed herein. The units comprise at least one controlled air, sealable, sterilizable cleanroom; and a mechanical system room adjacent to the cleanroom comprising: at least two air handling units in a support room adjacent the cleanroom that provide redundant air to the cleanroom with at least Class 100,000 air purity, the air handling units connected to a one or more supply ducts to the cleanroom, and an exhaust duct in communication with the cleanroom and the air handling unit exhaust, wherein a pressure gradient is formed between the cleanroom and the exterior of the structure; and at least two power supplies that provide redundant power to electrical outlets in the cleanroom, wherein the at least two power supplies are connectable to one or more external power sources and the structure is pre-validatable or validated for pharmaceutical manufacturing.

主权项

1. A manufacturing system comprising: a building shell; at least one corridor extending within the building shell;
a supply of two or more utilities from the building shell, wherein at least two of the two or more utilities are selected from the group consisting of (a) clean air, (b) chilled water, (c) electricity, and (d) nitrogen; a first movable manufacturing bay disposed within the building shell and positioned adjacent to the corridor and removably coupled for receiving the utilities; a first clean room defined by the first movable manufacturing bay and accommodating a first facility for performing at least a part of a manufacturing process; a second movable manufacturing bay disposed within the building shell and positioned adjacent to the corridor and removably coupled for receiving the utilities; a second clean room defined by the second movable manufacturing bay and accommodating a second facility for performing at least a part of a manufacturing process; a first entry point disposed between the first clean room and the corridor when the first movable manufacturing bay is removably coupled to the corridor, the first entry point for controlling access to and from the first clean room; a second entry point disposed between the second clean room and the corridor when the second movable manufacturing bay is removably coupled to the corridor, the second entry point for controlling access to and from the second clean room; wherein the first and second entry points are connected by the corridor such that personnel can pass between the first and second clean connect areas via the corridor; and wherein each of the first and second entry points comprises a gowning room and a de-gowning room separated from each other by a partition, wherein operating personnel can gown and de-gown within the gowning and de-gowning rooms, respectively.