Quality

International cGMP compliance:
YaoPharma’s oral solid production facility passed Health Canada and US FDA cGMP inspection.

Quality of the drug is crucial to a patient’s health. A substandard drug sometimes even endangers the life of a patient. High-quality products come from optimized and well-controlled production processes. The formulation of Lutasun is sterilized lyophilized powder for injection. In its production process, there are five critical points: API, water, lyophilizing, washing and sterilizing. Quality defects in any of these five points could cause undesirable effects on patients.

Quality of sterilized lyophilized powder is hard to control

API
Currently, fermentation is the only method to manufacture reduced glutathione. Control of its manufacturing process is extremely complex. Only few developed countries, e.g. Japan, can master it.
Water
Impurity or bacterial in the water used during preparing have fatal impact on the life of a patient.
Vial, rubber stopper
Preparation
Sterile filtration
Washing
In a high manufacturing speed, the capacity of equipment in washing and drying is critical to guarantee no impurity or bacterial in vials.
Lyophilizing
Pressure, temperature and time are the critical factors during lyophilization to make the lyophilized powder soft texture, moisture content in line with standards. The high-quality lyophilizer is the key here.
Sterilization
In a high manufacturing speed, the capacity of equipment in washing and drying is critical to guarantee no impurity or bacterial in vials.
Filling
Cap-crimping
Light inspection
Labelling
Packing

For each of the five critical points mentioned above, controlling the manufacturing process is technically challenging, therefore, quality varies significantly among the products from different manufacturers. We control the five critical points by the means of importing API from Japan and equipped with lyophilizer, vial washer and drying tunnel oven made by Japanese (Kyowac) or German (BOSCH) manufacturers, purifying water through double-reverse osmosis process and 6-stage distillation, ensuring that Lutasun is free from quality defects.

How do we guarantee the quality of GSH

API
We import high-quality API from Japan.
Water
The purified water is prepared through double-reverse osmosis process with filter membrane imported from the US. Subsequently, the purified water is distilled with the 6-stage distillation, and transformed into water for injection. Water for injection is stored in a tank made from stainless steel 316, and carried by the pipes in line with biological standards. With such a rigorous process, the quality of water for injection is guaranteed.
Vial, rubber stopper
Preparation
Sterile filtration
Washing
Our German-made (Bosch) washing machine and drying machine ensure that each vial well-cleaned and sterile in a high speed 24,000 vials per hour.
Lyophilizing
We are equipped with the Japanese-made lyophilizer (Kyowac), which can control the pressure, temperature and time during lyophilizing perfectly, ensuring the moisture content in line with standards and the texture softness. It also boasts the advanced functions of online cleaning and sterilizing to ensure the product sterility.
Sterilization
Our German-made (Bosch) washing machine and drying machine ensure that each vial well-cleaned and sterile in a high speed 24,000 vials per hour.
Filling
Cap-crimping
Light inspection
Labelling
Packing