At the beginning of the establishment, Jiangsu Haoke has introduced the advanced one-time production process (the production equipment is mainly linear equipment, except the auxiliary equipment). At the same time, the professional production management software is implemented to customize the production process. In addition, the production process follows the cGMP standard, and the whole process can be traced.
Disposable production equipment (process)
Eliminate possible cross-contamination during production
Produced in accordance with cGMP standards
Traceability of the whole process (from raw materials to finished products)
Customized professional production management software
ISO 9001 Quality Management System Certification
Clinical Application Medium Series DMF Record
Production filing and product filing for Class I medical devices
For the design of Haoke's production plant, our company specially invited well-known German bio-industrial design masters to participate in the design of each production line, and then cooperated with Nanjing Medical and Engineering Institute to determine the plan according to domestic regulations and the future development needs of Haoke. The overall design ensures that the workshop's production, process, environment, including equipment and facilities not only comply with China's biological regulations, but also meet advanced standards in the biological field such as Europe and the United States, and can meet the company's future development needs.