公开(公告)号：US09518748B2

公开(公告)日：2016-12-13

申请号：US12856888

申请日：2010-08-16

Applicant: R. Barry Holtz ,  Troy Arledge ,  Phillip B. Maples ,  David M. Shanahan

Inventor： R. Barry Holtz ,  Troy Arledge ,  Phillip B. Maples ,  David M. Shanahan

IPC: B01L1/04 ,  F24F3/16 ,  C12M1/12

CPC classification number: F24F3/16 ,  B01L1/04 ,  C12M37/00 ,  F24F3/161 ,  Y02A50/22 ,  Y10T29/49826

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 translation: 本文公开了生物安全单元，制造方法和密封方法。 这些单元包括至少一个受控的空气，可密封的可消毒洁净室; 以及与洁净室相邻的机械系统室，包括：在与洁净室相邻的支撑室中的至少两个空气处理单元，其向洁净室提供具有至少100,000级空气纯度的冗余空气，所述空气处理单元连接到一个或多个供应 与无尘室和空气处理单元排气连通的排气管，其中在洁净室和结构外部之间形成压力梯度; 以及至少两个电源，其为洁净室中的电源插座提供冗余电力，其中所述至少两个电源可连接到一个或多个外部电源，并且所述结构是预先验证的或用于药物制造的验证。

公开(公告)号：US20110053486A1

公开(公告)日：2011-03-03

申请号：US12856888

申请日：2010-08-16

Applicant: R. Barry Holtz ,  Troy Arledge ,  Phillip B. Maples ,  David M. Shanahan

Inventor： R. Barry Holtz ,  Troy Arledge ,  Phillip B. Maples ,  David M. Shanahan

IPC: B01L1/04 ,  B23P19/00

CPC classification number: F24F3/16 ,  B01L1/04 ,  C12M37/00 ,  F24F3/161 ,  Y02A50/22 ,  Y10T29/49826

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 translation: 本文公开了生物安全单元，制造方法和密封方法。 这些单元包括至少一个受控的空气，可密封的可消毒洁净室; 以及与洁净室相邻的机械系统室，包括：在与洁净室相邻的支撑室中的至少两个空气处理单元，其向洁净室提供具有至少100,000级空气纯度的冗余空气，所述空气处理单元连接到一个或多个供应 与无尘室和空气处理单元排气连通的排气管，其中在洁净室和结构外部之间形成压力梯度; 以及至少两个电源，其为洁净室中的电源插座提供冗余电力，其中所述至少两个电源可连接到一个或多个外部电源，并且所述结构是预先验证的或用于药物制造的验证。