苏州智享cGMP生产车间按照中国、美国和欧盟现行法规与指南进行设计并建造，各功能区配制齐全，人流、物流通道布局合理，能确保满足全球法规对生物制品生产设施的要求。

IntellectiveBio GMP facility is designed and constructed in accordance with the current regulations and guidelines in China, the United States and the European Union. Each functional area is fully prepared, and the layout for the flow of people and material is reasonable to ensures that the facility meets global regulations for biological product manufacture requirement.

作为一家专注于生物制品合同开发与生产的服务商，苏州智享生产车间采用单向流和一次性生产系统的设计理念，从源头降低污染、交叉污染的风险，保障客户和患者利益。

As a service provider focusing on the contract development and manufacture organization (CDMO) of biologics, IntellectiveBio has facilities using the design concept (uni-directional flow and single use production system) to reduce the risk of contamination and cross-contamination. This protects the interests of clients and patients.

• 产品流向按照工艺步骤单向流动

  Manufacture work flow is one-way flow during process steps

• 人物流，污物流向在各功能间保持单向流动并退出

  Personnel flow, material flow and waste flow are separated and one-way flow in each function area

• 采用一次性无菌封闭系统进行原液的生产

  Utilize sterile disposable close system on DS manufacturing

• 采用一次性无菌耗材系统进行无菌灌装产品的生产

  Utilize disposable sterile consumables for DP production

车间空调净化系统、纯化水系统、注射用水系统，已经过了全面确认，并建立了完善的日常监控体系，符合生产工艺和法规要求，能够持续为客户的产品质量保驾护航。

The HVAC system, purified water system, and water-for-injection system have been fully qualified, and a comprehensive routine monitoring plan has been established to meet the manufacturing process and regulatory requirements, which continually ensure the product quality for our clients.