Amaran Biotechnology installs first gloveless isolator of its kind in Taiwan
Exhibitor: AMARAN BIOTECHNOLOGY, INC.
Booth No.: N/A
Amaran Biotechnology, a pharmaceutical CDMO and subsidiary of Taiwan's OBI Pharma, has announced that the construction of its fully-automated aseptic filling line and facilities, a first in Taiwan, has been completed.
The new facility minimises the risks of human factors affecting the quality of the pharmaceutical products, and substantially enhances their safety. The project is now entering the final process validation phase of the medium fill procedures.
Amaran chose Vanrx's SA25 workcell for this project, a company based in Canada, and the aseptic production line was completed in two years.
Single-use consumables technology not only improves the efficiency of production, but also prevents the risks associated with cleaning validation and cross-contamination issues with conventional DP filling lines
Amaran Biotech’s Quality Management Vice President Jamie Hung said: “Vanrx SA25, the soon-to-be commissioned fully-automated aseptic filling equipment, 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," Hung added. "Using single-use consumables technology, the system not only improves the efficiency of pharmaceutical production, but also prevents the risks associated with cleaning validation and cross-contamination issues with conventional DP filling lines.”
In preparation for the system introduction, the facilities of Amaran Biotech were planned and designed according to the international regulatory guidelines including the US FDA, EU’s EMA, ICH, PIC/S and ISPE.
The new capabilities
Amaran Biotech’s fully-automated aseptic filling line integrates a gloveless isolation system and robotic arms to perform loading/unloading, filling, capping, sealing and inert gas replacement operations with advanced automation. Personnel 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 filling high-value liquid-type biopharmaceuticals. The system can be integrated with the lyophilisation process in the future to provide customers with more CDMO service options.
More Exhibitor's Press Release
- Comparison of Maglev Centrifugal Pump and Quaternary Diaphragm Pump Effects on mRNA encapsulated LNP LEVITRONIX GMBH TAIWAN BRANCH / 2023-03-21
- Nutrition supplement- Fast&Up effervescent tablet from Switzerland, keep you away from the pandemic. WENDY INTERNATIONAL LTD / 2023-03-08
- WIL charity association achieved great success with the campaign 「I dream it, I make it」. WENDY INTERNATIONAL LTD / 2023-03-08
- The pharmacist, Wendy, strictly controls the pharmaceutical material quality. WENDY INTERNATIONAL LTD / 2023-03-08
- The New BioFlo 720 Bioreactor Controller Is Compatible With The Thermo Scientific™ HyPerforma™ SUBs SUNTEX INSTRUMENTS CO., LTD. / 2023-03-08
- The SciVario Twin Next-Generation Bioreactor SUNTEX INSTRUMENTS CO., LTD. / 2023-03-08
- Mettler Toledo Intelligent Sensor Management (ISM®)sensors SUNTEX INSTRUMENTS CO., LTD. / 2023-03-08
- National Defense Medical Center 2023 Bio Asia Taiwan Exhibiting Projects NATIONAL DEFENSE MEDICAL CENTER / 2023-03-07
- Introduction Of Automatic Tablet ＆ Capsule Inspect YENCHEN MACHINERY CO., LTD. / 2023-03-03
- Yenchen Machinery act as agent of Enwave Optronics YENCHEN MACHINERY CO., LTD. / 2023-03-03
- Yenchen Machinery Was Awarded The Excellent Enterprise Award In Taoyuan City - Invisible Crown Award YENCHEN MACHINERY CO., LTD. / 2023-03-03
- INORA Brand Strategy to Drive Revenue Growth INORA PHARMACEUTICAL MACHINERY CO., LTD. / 2023-03-02
- INORA-Control system conform to 21 CFR PART11 INORA PHARMACEUTICAL MACHINERY CO., LTD. / 2023-03-02
- INORA─『Best Quality and Leading Technology』 INORA PHARMACEUTICAL MACHINERY CO., LTD. / 2023-03-02
- Envirotainer introduces the RAP for the future – part of the Releye® series ENVIROTAINER AB / 2022-06-22