As the leading manufacturer in the mass production of Liposomes in Asia, TTY implements strict control over API management, product storage, and cool chain logistics to secure drug quality and stability to international standard and ensure customers’ safety. Achieving the purpose of United Nations Sustainable Development Goal 12 "Responsible Consumption and Production".
API Management
Despite Taiwan's API management not yet being under GDP, the Chungli factory has followed the international management system and is ready to follow potential regulations in Taiwan. API storage and management comply with the GDP of PIC/S GMP. Liposome is a product under cool chain management. Since arrival at the factory, the API and excipient of Liposome are stored in a temperature-controlled warehouse with refrigeration equipment until entering the manufacturing process.
Product Storage
Upon the completion of product packaging, products are immediately stored in a warehouse of 2℃~8℃. To ensure 24-hour temperature control, all refrigeration warehouses are equipped with 2 air conditioners and fans so either can cover a faulty airconditioner should the occasion arise. All refrigeration warehouse equipment is linked to backup power to prevent equipment malfunction or power disruption.
General refrigeration warehouse maintenance, in addition to twice inspections every day, is subject to nonstop data logger and alarms inside the manufacturing warehouses. When the temperature exceeds a certain range, flashing lights and a sound alarm will go off and security will notify the relevant authorities accordingly. Every refrigeration warehouse in the Chungli factory is access-controlled, and only authorized warehouse personnel may enter the factory to safeguard products and minimize changes of temperature due to unnecessary entry and exit. A Temperature Mapping Qualification (TMQ) is conducted in every refrigeration warehouse during the coldest and hottest season of the year to ensure the temperature meets storage requirements.
Cool Chain Product Transportation
2℃~8℃ end-to-end temperature control must be followed during the transportation and delivery of Liposome to hospitals and clients. The warehouse and QC departments conducted a number of visits and audits to find a qualified logistics company that could ensure the storage, delivery, and temperature control of LN2, gel packs, and dry ice. TTY then signed agreements with such logistics companies who become qualified cool chain logistics suppliers for TTY.
Our Liposome is packed in the most suitable refrigerated delivery box made from qualified material and created the best size scientifically when being transported from the Chungli factory’s refrigerated warehouse. Moreover, the maximum number of times the ice can be used, its efficacy period, and other standard procedures are specified. The package is then sealed by TTY-Logo void tape with a 3M Monitor Mark. Every year TTY invests nearly a million NTD on WHO-certified 3M Monitor Marks. There were no cases of abnormal temperatures reported in year 2022.
Cool chain delivery by ground or by air to the Taiwan mainland, Kinmen, and Penghu should not exceed 24 hours from pickup to proof of delivery. 3 statistic tests and route dynamic tests are each performed for different box sizes, and the shortest delivery time should be selected and recorded as a standard for general transportation management. Validation should be run once every summer and winter to eliminate various factors affecting temperature changes during transportation.
Continuous Improvement
To continuously improve the stability of the cold chain, TTY optimizes the inner box of coolers and unifies the material and volume to facilitate the simplification of material and storage management. At present, the preliminary comparison and verification was completed in year 2022, confirming that the new inner box is better than the original one as it can provide more stable temperature and longer thermal insulation effect. The new inner box is expected to be fully in place in January 2023 so temperature remains stable during transportation to ensure product quality.
n addition, TTY expects to expand its refrigerated space in year 2022 as a response to increased demand for inventory and in line with the optimization of the production line for the oncology plant. After the construction and optimization of the production line for the oncology plant, semi-finished products can be stored and refrigerated space will convert semi-finished products into finished products in stages. The newly expanded refrigerated space will not only increase the refrigerated space for finished products by about 30 boards, but also enable the tally staff to have more space to conduct cold chain operations.