Sterile University


Sterile University Overview

Figure 1: Sterile University Overview

Sterile University Hall

Figure 2: Sterile University Hall

Main purpose


At Ausia BioTech, we understand that product quality and safety depend not only on hardware developments, i.e. facility design, equipment, etc, but also on software advances, such as training, research, testing and so on. Managing the business risks of non-compliance must include relevant and effective education. Human factor and innovation are two driving forces behind our recent effort in building the Center for Training and Management of Sterile Manufacturing, or “Sterile University” (Sterile U).

The sterile U is committed to a singular idea: providing practical training in sterile manufacturing and quality management for the pharmaceutical industry.

Sterile U is designed to present comprehensive, up-to-date content specifically structured for the unique needs of the pharmaceutical community. Courses are focused on four core areas: Pharmaceutical Engineering, Sterile Manufacturing, Quality Management and Regulatory Compliance.


Trainees


The first tier of trainees comes from Ausia’s own employees. We believe that investing in human capital will eventually pay off in terms of product quality, brand reputation, and excellent compliance track records. Quality management is a process that strives on continuous improvement. One of the simple ways to archive this is to rotate our employees through training programs in this state-of-art facility. We are also in the process of reaching an agreement with China FDA (SFDA) to provide training to their inspectors. Other perspective trainees includes employees from pharmaceutical companies, equipment vendors, and etc.

We partner with subject matter experts universities, regulatory agencies, equipment vendors, and consulting firms to develop high-impact, customized training solutions to meet the needs of the industry. Our instructors and program designers possess a unique blend of experience with a deep understanding of the core functional area of the pharmaceutical industry and its operating principles.

Classroom and Meeting Rooms:








Simulation Areas:


Training offered at Sterile U has a strong emphasis on hands-on, practical activities. For example, trainees can utilize the production facility to practice the skills and knowledge they learn through classroom training. At the same time, the Cleanroom Behavior Lab can analyze the impact of human and equipment activities to the cleanroom environment.

Gowning Activities:








Washing and Assembling Activities:








Cleanroom Behavior Lab:








Managing human factors


The message Sterile U tries to send out is clear: managing human factors and advancing through innovation are essential in delivering qualified products. Patients depend on us to provide a quality product. That’s why quality and compliance are fundamental in our culture. Finally, we firmly believe that understanding not only our own function, but the responsibilities and contents of other functions, helps us operate with a more strategic perspective and have a greater sense of value and purpose.


 
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