Relying on its rich experience in processes, regulations, manufacturing, operations, and verification in the field of microbial fermentation and synthetic biology, Triowin integrates digital and intelligent application technologies to provide personalized overall solutions for fermentation and pharmaceutical companies of different sizes, covering everything from raw materials, warehousing, processes, manufacturing, quality, equipment maintenance to final products, forming an overall solution capability for the entire process of bioengineering smart factories.
The solutions provided by Triowin strictly follow GMP requirements to ensure the safety and quality controllability of the entire preparation and filling process. This not only helps customers' products pass regulatory approval smoothly, but also ensures the market acceptance and patient safety of the final product.
The stainless steel liquid preparation and distribution system integrates all key components, such as tanks, high-efficiency agitators, precision sterilization and filtration devices, etc., and with a comprehensive operating platform and intelligent operating system, it not only simplifies the installation and operation process, but also improves the overall efficiency of the system. The modular design allows the system to be flexibly adjusted and expanded according to different production stages or future production needs, reducing long-term operating costs. The aseptic processing capability system supports cleaning in place (CIP) and sterilization in place (SIP), effectively avoiding cross contamination and ensuring a sterile environment during the preparation and filling process.
In response to the diverse needs of customers, Triowin not only provides traditional stainless steel systems, but also single-use systems (SUS) or hybrid solutions (combining stainless steel and disposable components), which greatly enhance the adaptability and economy of the production line.
During the small-scale production and R&D stages, Triowin's intelligently integrated disposable formulation, sterilization filtration, aseptic storage and transfer systems, and disposable filling pipeline systems not only reduce the need for cleaning validation and speed up product launch, but also improve process flexibility and ease of operation. It is an ideal choice for rapid response to market changes and new drug development.
The downstream granulation and packaging workshop is mainly responsible for converting the active substances obtained from the upstream fermentation into a stable final product form that is easy to store and use, including granulation, drying, mixing, packaging and other steps.
After fermentation is complete, a harvesting step is performed to separate the target product from the fermentation broth. This involves physical methods such as centrifugation and filtration to remove cell debris, unused raw materials and other impurities. Subsequently, the primary purification stage uses chromatography, ultrafiltration, extraction and other techniques to further improve the purity of the target product.
Granulation is the process of converting pure active substances into granular forms suitable for oral administration or further processing. Wet granulation is done by mixing the active ingredients with a binder, using a granulator to form a wet mass and then drying it into granules; dry granulation is done by directly bonding the powder into granules under high pressure; melt granulation is suitable for heat-stable materials, which are formed into granules by melting and spray cooling.
The wet granules obtained by drying and granulation need to go through a drying process to remove excess moisture, ensure product stability and prevent microbial growth. Drying technologies include fluidized bed drying, spray drying, etc., which can complete the drying task efficiently and quickly while maintaining the good shape of the granules. After drying, the granules need to be appropriately crushed and screened by granulation equipment to ensure that the particle size distribution meets the requirements.
In order to ensure that the ingredients of each tablet or package of medicine are uniform, the dried particles will enter the mixing process and be evenly mixed with excipients such as fillers and lubricants. Drugs that need to control the release rate or improve the taste will also be coated.
The Triowin packaging line can efficiently complete a series of operations such as metering, filling, sealing, labeling, etc. According to the nature of the drug, various forms such as bottle packaging, blister packaging, and strip packaging can be selected. During the entire packaging process, a sterile environment and quality control are essential to prevent contamination and meet GMP (Good Manufacturing Practice) standards.