Company Introduction |
Company Profile
CHANSE regards “Keep Innovating, Pursue Excellence, Create Standards and Serve Customers” as mission since foundation of 2004. Adhering to years of careful efforts, CHANSE’s solid preparation equipments of independent research and development has reached international advanced level in manufacturing quality and use performance. CHANSE is praised as "made in China with German quality” by domestic and foreign counterparts. Meanwhile, CHANSE provides customers with full support from process exploration, process optimization to process scale-up. Besides, CHANSE introduces and develops smart production lines with “Continuous Granulation, Real-time Release”. Relying on PAT technology and MES, CHANSE achieves digitalized, informationized and intelligent plants, and provides powerful safeguard for the quality and efficacy of drugs.
Company Introduction
Equipment expert of oral solid dosage preparation
Process Technology Research Center
Formerly known as CHANSE science and technology department, it was founded in Shanghai Zhangjiang High Tech Park in 2008. In 2017, Changzhou Municipal oral solid intelligent process engineering technology center was established. In 2018, a continuous granulation laboratory was set up, and through the application of process analysis technology (PAT), a total solution from product development cycle shortening, process scale up to process quality design (QbD) was provided with the support of experimental design. The laboratory of 500 square meter consists of clean area and non-clean area. It includes all kinds of lab size, pilot test equipment, and intelligent management system with LIMS system as the core, which can meet various process requirements of solid preparations. At present, CHANSE provides process support services of about 200 different varieties for clients every year.
Factory Overview
The plant area is over 40,000 square meters, including R & D office building, manufacturing workshop, assembly and debugging workshop, processing workshop, warehouse, lab size and pilot test laboratory, etc. Besides, there are many advanced equipment, such as CNC machine tools, machining centers, laser cutting and welding robots. Digitalized and informationized smart network management platform has been established.
Company Culture
Gather Strength and Work together with High Aspirations!
1.CHANSE regards “Keep Innovating, Pursue Excellence, Create Standards and Serve Customers” as our core value, infiltrates “win-win cooperation” into our operation and management, and establishes our corporate value and operation ideas with CHANSE’s characteristics.
2.CHANSE focuses on creating new industry standards and provides an integrated process solution with excellent quality, such as dust-free high containment granulation line, vertical-flow granulation line, OEB5, AGV system, WIP system, and so on. CHANSE provides customers with technical support from process exploration to process scale up, helping customers improve product quality, improve yield, improve efficiency, reduce labor and energy consumption, save raw and auxiliary materials, so as to help customers increase benefits and reduce costs.
3.CHANSE always takes innovation and technologies as our core competitiveness. Adhering to independent research and development, and integrating international advanced technologies for innovative improvement, CHANSE aims to lead the development of the pharmaceutical industry towards higher quality, higher efficiency, higher reliability and higher safety.
Company Honor
Win-win cooperation
deputy-director unit of Intelligent Manufacturing Committee of China Pharmaceutical Industry Associationmember unit of the Intelligent Manufacturing Special Committee of China Association of Traditional Chinese Medicinedirector unit of China Medicine Education AssociationCHANSE has laboratories co-built with China Pharmaceutical University, Shenyang Pharmaceutical University and Xiangya School of Medicine, Central South University.
Professional Team
Keep Innovating, Pursue Excellence
CHANSE’s backbones are graduated from professional pharmaceutical colleges, such as China Pharmaceutical University, Shenyang Pharmaceutical University and so on. They all have more than 20 years’ working experience in the pharmaceutical industry and have been the general manager of pharmaceutical factory, the quality authorizer, the general manager of R&D and the general manager of API R&D.
Production guidance
1.More than 20 years working experience in pharmaceutical factory.
2.He has been responsible for EMEA and FDA certification projects of API and preparation,
3.He has been responsible for equipment, energy, metrology and project construction management, entrusted processing of drugs, drug production, and led the team to do liquid preparation system, water system and blood product system of pharmaceutical enterprises.
4.He has cooperated with European and American experts in the design and construction of oral solid preparation, monoclonal antibody and API.
5.He has been invited by China food and drug international exchange center to train provincial flight inspection officials and has been invited to be included in the intelligent manufacturing expert database of MIIT.
6.He has been invited to teach courses by the drug administration departments of Guangdong province, Zhejiang province, Jiangsu province, Jiangxi province, Anhui province, Hainan province, Tibet autonomous region and other pharmaceutical groups such as Yangzi River, 7.Tianshi, Hengrui, Kelun, Fosun, Qilu, etc.
8.He has made technical exchange reports in Shenyang Pharmaceutical University, China Pharmaceutical University, the third, fourth and Fifth Asian pharmaceutics forum, international excipients exhibition, 2015-2020 ISPE annual meeting, China pharmaceutical preparation conference, and speech of intelligent pharmaceutical equipment special committee of China Chemical Pharmaceutical Industry Association.
Catalog
Based on years of accumulation in the pharmaceutical industry, advanced pharmaceutical concept and excellent process understanding, good equipment performance and engineering advantages, CHANSE develops total solution of digitalization, informatization and intellectualization with customers in pharmaceutical industry. To meet the challenges of "industry 4.0" and "made in China 2025" era, CHANSE will help China's pharmaceutical industry realize industrialization upgrading and develop towards the direction of high quality and low cost.
In 2018, at the invitation of CFDA, CHANSE participated in the compilation of the Guidelines for OSD Process and On-Site Inspection of Oral Solid Dosage Products. It is our commitment to society to create higher industry standards and strive for more significant and stable drug efficacy.
To provide professional customized solutions, industrial technical support and intelligent production mode is CHANSE’s philosophy. To contribute to the society and benefit the people is CHANSE’s corporate responsibility. To realize intellectualization of China’s high-end pharmaceutical equipment and make ‘Made in China’ become a world standard are CHANSE’s eternal visions!
Total Solution
PAT Series
TEWS Moisture Measuring Instrument
In-Line Real Time Particle Analyzer
FT-NIR Process Analyzer
OSeeT Optical Coherence Tomography
Smart MES
Continuous Granulation
HME
Ezi-Dock High Containment Transferring System
EPCV Service for OSD
Equipment Introduction
Granulation Drying Closed Transfer WIP System
Multi-Functional Fluid Bed
High Shear Mixer / Wet Granulator
Roller Compactor
Low Shear Vertical Extruder and Spheronizer
Isolator
High Efficient Coater
Hopper Blender
Hopper
Mobile Mill
Total Solution
Intensively Research on Solutions, refine on Technologies and Processes
PAT smart testing system
In-Line Real Time Particle Analyzer
TEWS Moisture Measuring Instrument
FT-NIR Process Analyzer
OSeeT Optical Coherence Tomography
PAT Products
Innovative technology leads the future
Advanced PAT system helps to reflect the real time changing trend of material, product or overall state during process operation, which provides in-time feedbacks for process parameter adjustment and eliminates product quality risk. Online PAT system is the basis of intelligent production process. It has the following advantages:
1.Shorten R & D and production cycle, improve productivity
2.Reduce the deviation of inspection results in batch production and R & D
3.In depth understanding of process technology
4.Optimize and stabilize the process technology
5.Improve the feasibility of products scale up
6.Feedback controls the production process
7.Improve first pass yield and improve quality consistency between batches
8.No damage to the product, reduce the cost of sampling and testing, and improve the analysis efficiency
9.Reduce the inventory of intermediate products and reduce the cost of workshop
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