Advanced Solution Prep System for Complex Formulations

The client is a pharmaceutical company with the integration of pharmaceutical R&D, production and sales, and was listed on SSE A share on July 19, 2017. The company has not only world leading isolator production line and advanced aseptic injection production technology, but also has established a globalized quality system, approved by many countries and regions, including China, the United States, Europe, Japan and Brazil, etc. AUSTAR provided 4 sets of chemical drug solution preparation systems in total in 2021, one of which was propofol fat emulsion solution preparation system. All product parameters during the client's trial production phase were superior to those of the innovator drugs.

AUSTAR Solution

Process design and highlights: - Fully automatic customized equipment, which can edit the process parameters and operate automatically; through parameter conditions setup, the equipment can operate according to the set program. The whole process can be performed automatically by one button. - The replenishment of the oil phase tank is realized by vacuum suction transfer, and CIP&SIP can be online performed, optimizing the conventional manual feeding and offline washing methods, and saving workload. - Oil phase and water phase enter the shearing machine to form primary emulsion, and the ratio of the “oil to water” is precisely controlled by pump and mass flow meter to guarantee that the quality of the primary emulsion complies with the process requirements. - The switchover of the bypass path of the heat exchanger is added for the circulating and pressure boost between the primary emulsion tank and homogenizer, which can effectively avoid the heat exchanger being clogged by large particles and consequent non-uniform homogenizing. Three-dimensional design and highlights: - Tank leg heightening bracket - Mixture feeding pipe of the shearing machine - Vibration-proof flexible pipe for the homogenizer

AUSTAR Value & Client Benefits

• The key parameters of the current products are superior to those of the original research drugs, which significantly enhances the quality of the products and the consistency between batches. • The full - process one - key automated operation and vacuum feeding instead of manual feeding have improved production efficiency and the overall safety of operations. • Enhanced compliance and international capabilities provide strong compliance guarantees for the global market access of customers' drugs.

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