Introduction of the Company's Production System
Fangsheng Green Chemical Pharmaceutical Co., Ltd. has established a mature production management system, which is divided into Production Department I and Production Department II. Production Department I is engaged in the production of APIs, and Production Department II is mainly responsible for the extraction of traditional Chinese medicine. At present, Production Department I has completed the construction of the workshop 101 project, and staff have passed the company's training in production process, GMP, safety, environmental protection, etc. The workshop is equipped with glass lined reactor, stainless steel reactor, centrifuge, double cone dryer, circular dryer, airflow pulverizer, universal pulverizer, three-dimensional mixer and so on. The relevant public systems include Roots water jet vacuum unit, water jet vacuum unit, purified water system, air compression nitrogen system, air conditioning system.
The 101 workshop is divided into general area and Class D clean area, which can meet the needs of multiple plant facilities and equipment. At present, there are varieties of Ezetimibe, Ornidazole, Benidipine Hydrochloride, Glucosamine Sulfate Sodium Chloride in Workshop 101. And Ezetimibe passed the GMP on-site compliance inspection in October 2021.
The API is equipped with a high-level technology room, which is mainly responsible for the process optimization of existing varieties and the process routine confirmation of new varieties. Production Department I has the ability to undertake CMO/CDMO business.
Workshop 201 is a multi-functional production workshop for pretreatment and extraction of traditional Chinese medicine subordinate to Production Department II. It is designed and built as a multi-storey industrial workshop with four floors of cast-in-situ reinforced concrete frame structure above the ground. The total area of structure of the workshop is more than 13000 square meters. The workshop is equipped with alcohol extraction and water extraction production lines to meet the production needs of multiple varieties and different extraction processes. The overall capacity of the workshop is designed to handle 20000 tons of traditional Chinese medicine materials annually. At present, the Phase I project ( handle 5000 tons of traditional Chinese medicine materials annually) has been successfully completed and passed the GMP on-site compliance inspection in September 2022.
The equipment and facilities are complete, and the workshop is equipped with more than 100 sets of pre-treatment, extraction &concentration equipment, dryers and utility system such as the automated production line, dust-free crushing unit, multi-functional extraction tank, alcohol sedimentation tank, single and double effect concentrator, falling film MVR concentrator, ethanol recovery tower, spray dryer, low-temperature pulse vacuum dryer, low-temperature vacuum belt continuous dryer, various storage tanks, reverse osmosis purified water unit. Following the forefront of the industry, the workshop is equipped with advanced slag removal and output systems to ensure that the production environment fully meets the requirements of environmental protection and GMP.
The workshop has established a integrated GMP production quality management system, equipped with a high-level production quality management team, and all employees have received systematic and strict GMP training, with high quality awareness and strong job skills, which can ensure that the workshop can consistently produce products that meet the quality requirements.