The USA IV bag turnkey project, the first pharmaceutical turnkey project in the United States undertaken by a Chinese company – IVEN Pharmatech, has recently completed its installation. This marks a significant milestone in China pharmaceutical industry.

IVEN designed and constructed this modern factory in strict compliance with US CGMP standard. The factory complies with FDA regulations, USP43, ISPE guidelines, and ASME BPE requirements, and has been validated through the GAMP5 quality management system, enabling a comprehensive quality control system that covers the entire process from raw material handling to finished product warehousing.

The key production equipment integrates automation technology: the filling line adopts the full-process linkage system of printing-bag making-filling, and the liquid dispensing system realizes CIP/SIP cleaning and sterilizing, and is equipped with high-voltage discharge leakage detection device and multi-camera automatic light inspection machine. The back-end packaging line achieves a high-speed operation of 70 bags/min for 500ml products, integrating 18 processes such as automatic pillow bagging, intelligent palletizing and online weighing and rejecting. The water system includes 5T/h pure water preparation, 2T/h distilled water machine and 500kg pure steam generator, with online monitoring of temperature, TOC and other key parameters.

The plant complies with international standards such as FDA, USP43, ISPE, ASME BPE, etc., and has passed GAMP5 quality management system validation, forming a whole-process quality control system from raw material processing to finished product warehousing, ensuring that the final sterilized products with an annual production capacity of 3,000 bags/hour (500ml specification) comply with the global regulatory requirements for pharmaceuticals.

In five Central Asian countries, most of pharmaceutical products are imported from foreign countries. Following several years of hard work, we have helped customers produce pharmaceutical companies in these countries provide affordable products to domestic users. In Kazakhstan, we built a large integrated pharmaceutical factory, including two soft bag IV-solution production lines and four ampoules injection production lines.

In Uzbekistan, we built a PP bottle IV-solution pharmaceutical factory capable of producing 18 million bottles annually. The factory not only brings them considerable economic benefits, but also gives the local people access to more affordable medical treatment.

In Russia, although the pharmaceutical industry is well established, much of the equipment and technology used are outdated. After multiple visits to European and Chinese equipment suppliers, the largest injection solution pharmaceutical manufacturer in the country chose us for their PP bottle IV-solution project. The facility can produce 72 million PP bottles per year.

In Africa, many nations are in a stage of developing and many people do not have sufficient healthcare access. Currently, we are building a soft bag IV-solution pharmaceutical factory in Nigeria, capable of producing 20 million soft bags per year. We look forward to producing more high-class pharmaceutical factories in Africa. Our hope is to help the people of Africa by providing equipment that will result in safe pharmaceutical products.