PDA的湿热消毒系统工作组已经开发了一份科学技术报告，将帮助您设计和操作湿热消毒器。提供以下方面的建议:设置用户要求和规范设计鉴定（DQ）设备和控制系统设计湿热灭菌器的功能要求和支持灭菌要求的公用设施的期望操作，包括校准和维护设备鉴定，其中可能包括工厂验收测试（FAT），现场验收测试（SAT）和调试持续控制要求循环开发本技术报告涉及用于制药、医疗器械和生物技术行业的湿热消毒器。 本技术报告的重点是湿热灭菌器的设计和操作，从用户需求规范（URS）的制定到设备鉴定（安装鉴定（IQ）/操作鉴定（OQ）），最后是持续的维护要求。本报告的重点不包括性能鉴定（PQ）。读者可参考PDA技术报告第1号（2007年修订版），以讨论负载循环开发和工艺性能鉴定。

PDA's Moist Heat Sterilization Systems Task Force has developed a scientific technical report that will help you design and operate moist heat sterilizers. Advise is offered on the following areas:Setting User Requirements and SpecificationsDesign Qualification (DQ)Equipment and Control System DesignFunctional Requirements for the moist heat sterilizer and expectations for utilities supporting the sterilizerEquipment Operation, including calibration and maintenanceEquipment Qualification, which may include Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioningOn-going control requirementsCycle DevelopmentThis Technical Report addresses moist heat sterilizers intended for use in the pharmaceutical, medical device and biotechnology industries. This technical report focuses on the design and operation of moist heat sterilizers, from the development of User Requirements Specifications (URS) through equipment qualification (Installation Qualification (IQ) / Operational Qualification (OQ)) and culminating with ongoing maintenance requirements. The focus of this report does not include Performance Qualification (PQ). The reader is directed to PDA Technical Report No. 1 (2007 Revision) for discussion of load cycle development and process Performance Qualification.