Production
As people's lives may depend on the efficacy and safety of Tissue Engineered Medical Products (TEMPs), their manufacture must result in products of the highest possible quality. J-TEC complies with the GMP standards for the manufacture of drugs and medical devices. The environment within our production facilities is thoroughly controlled, with the use of high-performance equipment and a facilities management system to maintain its highly clean state. Furthermore, to enable the production of high-quality, reliable products within this environment, production is carried out by operatives who are fully trained in cell culture techniques and who work according to standard operating procedures.
J-TEC Head Plant (right) and Research Facility (left)
Image Layout of Facilities
Clean Environment
A HEPA filter*1 has been installed and a Class 100*2 environment is maintained to enable sterile operations.
*1HEPA filter: A High Efficiency Particulate Air (HEPA) filter purifies the air by removing particles of diameter 0.3 micrometers or greater with an efficiency of 99.97% or more. It is necessary for clean environment and sterile operations.
*2Class 100: An extremely clean environment, with less than 100 particles of diameter 0.5 micrometers or greater per cubic foot of air.
Safety Cabinet
Clean Room Corridor
Facility Control and Monitoring System
Centralized monitoring system conducts 24-hour monitoring of air conditioning and production facilities to maintain clean environment. Security measures based on fingerprint authentication is implemented to control entry to the GMP area.
Centralized Monitoring System
Entry Control by Fingerprint Authentication
Fully Trained Operatives
All operatives possess specialist knowledge in cell cultivation and have been fully trained concerning the specific knowledge and cell culture techniques required for TEMPs. Only personnel who have thoroughly mastered the necessary skills are employed.
Efficient Operation using Connectable Safety Cabint
Use of Pass Box