Abstract: Biosafety units, methods of making and sealing the same are disclosed herein. The present invention includes a unitary structure able to be validated for pharmaceutical manufacturing comprising: at least one controlled air, sealable, sterilizable cleanroom; a mechanical system room adjacent to and separate from the cleanroom comprising: one or more air handling units that provide conditioned air to the cleanroom; and one or more power busses that provide power to electrical outlets in the cleanroom from two sources, wherein the at least two power supplies are connectable to one or more external electrical power sources; an integrated fire suppression system integral to the cleanroom; and one or more corridor connectors, wherein a corridor can be attached at the corridor connector.

Abstract: Biosafety units, methods of making and sealing the same are disclosed herein. The present invention includes a unitary structure able to be validated for pharmaceutical manufacturing comprising: at least one controlled air, sealable, sterilizable cleanroom; a mechanical system room adjacent to and separate from the cleanroom comprising: one or more air handling units that provide conditioned air to the cleanroom; and one or more power busses that provide power to electrical outlets in the cleanroom from two sources, wherein the at least two power supplies are connectable to one or more external electrical power sources; an integrated fire suppression system integral to the cleanroom; and one or more corridor connectors, wherein a corridor can be attached at the corridor connector.

Abstract: Biosafety units, methods of making and sealing the same are disclosed herein. The present invention includes a unitary structure able to be validated for pharmaceutical manufacturing comprising: at least one controlled air, sealable, sterilizable cleanroom; a mechanical system room adjacent to and separate from the cleanroom comprising: one or more air handling units that provide conditioned air to the cleanroom; and one or more power busses that provide power to electrical outlets in the cleanroom from two sources, wherein the at least two power supplies are connectable to one or more external electrical power sources; an integrated fire suppression system integral to the cleanroom; and one or more corridor connectors, wherein a corridor can be attached at the corridor connector.

Abstract: The present invention includes a removable utility unit and/or removable utility room for providing one or more utilities to at least one of a controlled air, a sealable, a sterilizable, a sanitizable cleanroom comprising: at least one of a utility connection selected from air, water, gas, or electricity; and a substantially hermetic connector between the removable unit and the cleanroom, wherein the at least one of air, water, gas, or electricity are connectable to matching utility inputs in the cleanroom.

Abstract: Biosafety units, methods of making and sealing the same are disclosed herein. The present invention includes a unitary structure able to be validated for pharmaceutical manufacturing comprising: at least one controlled air, sealable, sterilizable cleanroom; a mechanical system room adjacent to and separate from the cleanroom comprising: one or more air handling units that provide conditioned air to the cleanroom; and one or more power busses that provide power to electrical outlets in the cleanroom from two sources, wherein the at least two power supplies are connectable to one or more external electrical power sources; an integrated fire suppression system integral to the cleanroom; and one or more corridor connectors, wherein a corridor can be attached at the corridor connector.

Abstract: Biosafety units, methods of making and sealing the same are disclosed herein. The present invention includes a unitary structure able to be validated for pharmaceutical manufacturing comprising: at least one controlled air, sealable, sterilizable cleanroom; a mechanical system room adjacent to and separate from the cleanroom comprising: one or more air handling units that provide conditioned air to the cleanroom; and one or more power busses that provide power to electrical outlets in the cleanroom from two sources, wherein the at least two power supplies are connectable to one or more external electrical power sources; an integrated fire suppression system integral to the cleanroom; and one or more corridor connectors, wherein a corridor can be attached at the corridor connector.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: The present invention includes a removable utility unit and/or removable utility room for providing one or more utilities to at least one of a controlled air, a sealable, a sterilizable, a sanitizable cleanroom comprising: at least one of a utility connection selected from air, water, gas, or electricity; and a substantially hermetic connector between the removable unit and the cleanroom, wherein the at least one of air, water, gas, or electricity are connectable to matching utility inputs in the cleanroom.

Abstract: 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.