::: 台灣東洋製藥 | TTY Biopharm :::

State-of-the-art Oncology Plant – Modern factory with high QC standards

Professional Facilities

TTY Biopharm strictly demands each detail, including environment, equipment, and protection of employees, and insists on high standard operations to ensure the quality of drugs and protect the safety of employees.

Professional Factory of Orally Taken Cancer Medications

The factory, located on the first floor of Building C, launched mass production in March 2001. It is 550 square meters in area and equipped with advanced equipment for the production of orally taken cancer capsules.

Cleanroom Applications

‧Special apparel designed for cleanrooms is used in normal work areas to ensure an uncontaminated environment.
‧ Disposable Dupont Tyvek garments are worn in high-risk work areas to ensure safety of our employee.
‧ Disposable Dupont Tyvek visor is applied to prevent repetitive use.
‧ 3M 8710 mask is adopted to ensure the safety first policy.
‧ Half calf bootees specially designed for cleanrooms are worn.

Advanced Equipment

‧ The visitor’s pathway is built apart form the production area to keep our visitors from contaminations.
‧ The factory is replete with advanced equipment and machines made by Germany Glatt, UK Phaematech Inc., Korea Puchon, Taiwan Haur Sheng Machinery Company, Shang Yuh Machine Company, and Chin-Yi Machinery Co.。
‧ From materials release to final packaging, the production is conducted within closed containers so as to minimize particles and risks of contraindication.
‧ All of the production equipment are computer-controlled to ensure a standard quality of our products.

Professional Factory of Cancer Injection

To reach the highest production standard, we re-planned and modified the origin factory to establish a professional factory of cancer injections with a systematic production line. With a comprehensive design, the new factory will be completed and launched at the end of November 2007. This cancer injection factory is located on the first floor of Building B, measured 986 square meters in area and equipped with advanced equipment specially for producing cancer injections.

Sterile Production

‧ From the material, production to the storage of final products, all processes are conducted on the same floor with a continuous production line conforming to the 5-flow planning to avoid cross contamination.
‧ The facility is an airtight enclosure space design, which can ensure sterile characteristics and avoid the leak of medicine.
‧ The Millipore sterile membrane filtration system and membrane integrity testing instrument are used.
‧ A complete sterile environment and monitoring of personnel is maintained to comply with PIC/S specifications.

Advanced Equipment

‧The visitor’s pathway is built apart form the production area to keep our visitors from contaminations.
‧Professional equipment for producing liposome cancer injection.
‧A closed mixing equipment with the Sweden NovAseptic bottom stirring system is used to avoid contamination.
‧Automatic washing, sterilization and filling equipment for ensuring the highest quality of production.
‧All production machines are controlled by computer systems to ensure stable quality of the products.

Factory for Other Formulations

To prevent cross contamination, Building M is built as the factory for producing external medicines, especially Mentholatum external medicines. This factory is completed and starts the mass production in January 2007.

Professional Support Systems

Water Purification System

‧ Establish water supply system, water purification system, and injection water system for different uses.
‧ All systems are monitored by computer to maintain high-speed cycling and purification around the clock.
‧ Seamless plumbing is adopted to prevent any possible contamination.
‧ GE online TOC monitoring system is adopted to ensure the highest quality of water.

Air Conditioning System

‧Production areas are divided in to Grade A, B, C and D according to the requirements of the production, and comply with PIC/S standards.
‧Each grade area is supplied with air from its own air conditioning system.
‧The pressure, temperature and humidity of production areas are indicated micro-computer controllers. Alarms will go off in case of any atypical numbers.

Environmental Protection

‧The factory is equipped with a computer-controlled incinerator capable of burning at 1000℃ to ensure that the emission complies with environmental protection specifications.
‧Equipped with advanced computer-controlled dry and wet dust collecting and wastewater processing equipment. The emission is tested and approved to be directed to the disposal station of the sewage treatment factory in the industrial area.

High QC Standards

‧ Quality Assurance Department (QA) strictly monitors the quality.
‧ Ensure the implementation of the quality policy and perform validations.
‧ Strict document control and audit management to ensure the quality standard.
‧ Comprehensive non-conformity control and customer complain service to ensure high satisfaction.
‧ Quality Control Department (QC) performs professional laboratory testing.
‧ Independent QC laboratory (Building D) and the entrance control to monitor the safety.
‧ Advanced equipment include the following:
　　◎ Waters high performance liquid chromatography
　　◎ Varian high performance gas chromatography
　　◎ Varian atomic absorption spectrophotometer
　　◎ Perkin Elmer infrared absorption spectrophotometer
　　◎ Varian ultraviolet ray / visible light analyzer
　　◎ Malvern particle analyzer device
　　◎ Beckman Coulter nano particle analyzer
　　◎ Varian automatic dissolution testing system

Outstanding Production Management

‧ The warehouse management strictly monitors the environmental condition for storage. A special cold storage area is available for products that need to be stored in a cold environment.
‧ A computerized ERP system is built to improve the quality and management. In addition to the current AS-400 system for managing materials and products, a new advanced ERP system is introduced to enhance the management.