/ Integrated Process and Packaging Equipment & Systems / Case Study

Complex Preparation-Suspensions-Preparation System

The client is a high-tech innovative pharmaceutical enterprise dedicated to developing high quality inhalation preparations and innovative drug delivery systems with the integration of R&D and production. At present, the company has already built the internationally advanced scientific platform for innovative drug delivery systems, such as inhalation aerosols, powder aerosols for inhalation, atomizing agent for inhalation and nasal spray. The original inhalant production line could not meet the production capacity requirements of the company. A set of inhalant suspension process system was needed to add, with compliance with cGMP standards.

AUSTAR Solution

Suspensions preparation design, installation, construction and validation services were provided. All skids were assembled at site. AUSTAR adhered to high quality services, without technical deviation at all through out the project execution and validation.

Highlights

Successfully delivered a high-standard cGMP suspension preparation system, assisting the client in passing the GMP inspection for the BFS production line.

Achieved zero quality deviations during high-intensity work through modular construction.

Earned high client recognition through professional services, resulting in consecutive years of orders.

AUSTAR Value & Client Benefits

• The client successfully passed Chinese GMP inspection for BFS radioactive drug production line . • AUSTAR technical service abilities and teamwork spirit were high recognized, and also the progress control of overall project and the construction quality. Suspension preparation systems for budesonide production were provided successively in 2021 and 2022, including design, implementation, validation and later stage maintenance.
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