First aseptic filling line and facilities completed in Taiwan

July 13, 2022 - 2 minutes
Image: Amaran Biotech

The construction of a fully-automated aseptic filling line and facilities has been finished in Taiwan.

Amaran Biotechnology Inc., a subsidiary of Taiwan’s OBI Pharma Inc., made the announcement that the new facility, a first for the country, minimizes the risks of human factors affecting the quality of pharmaceutical products, and enhances their safety.

The project is now entering the final process validation phase of the medium fill procedures.

Amaran says the new facility cements its reputation and many years of experience in the development of manufacturing process of high-value biopharmaceuticals, analysis services, and solutions for cGMP solutions. It says it will help to strengthen its position as the original equipment manufacturers (OEM) of active pharmaceutical ingredients (APIs) of OBI Pharma’s active immune-oncologic therapeutic products.

Gloveless, automated robotics

Jamie Hung  Amaran Biotech’s quality management vice president  said: “The soon-to-be commissioned fully-automated aseptic filling equipment, called Vanrx SA25, originates from Canada and is the first gloveless, automated robotics arm aseptic filling system in the world.

“We are thrilled that Amaran Biotech is the first company in Taiwan to successfully introduce the system. Using single-use consumables technology, the system not only improves the efficiency of pharmaceutical production, but it also prevents the risks associated with cleaning validation and cross-contamination issues with conventional DP filling lines.”

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Aseptic production line

In preparation for the system introduction, the facilities at Amaran Biotech were planned and designed according to the international regulatory guidelines and the aseptic production line was completed in two years.

The fully-automated aseptic filling line integrates a gloveless isolation system and robotic arms to perform loading and unloading, filling, capping, sealing and inert gas replacement operations with advanced automation.

Human intervention is not needed during the process to complete the operations. The system can fill vials, pre-filled syringes and cartridge formats ranging from 0.1 to 50 mL with a filling precision of 99.99%, suitable for the filling of high-value liquid-type biopharmaceuticals. The system can be integrated with the lyophilization process in the future to provide customers with more CDMO service options.

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