In recent years, there have been major advances in automation equipment for the manufacture of radiopharmaceuticals.
Creating modern facilities that incorporate automated manufacturing processes improves product consistency, quality, and operator safety.
Many radiopharmaceuticals are produced under aseptic conditions to ensure they meet all purity and quality standards. There can be multiple manual processes in the manufacturing of sterile drugs, and each manual process during the aseptic assembly has the potential to introduce contamination. In addition to product safety, operator safety can be improved when introducing automation by reducing radiation exposure to personnel.
Automation in Hot Cells
Most operations in the hot cell are accomplished by using manipulators and robotic arms. Robotic arms can be programmed to automate processes inside and outside the hot cell including the opening of lead pots, the handling of lead pots and vials, automatic filling, and automatic visual inspection of labeling and cartoning. These automated processes can increase production speed, product quality, and reduce radiation exposure to operators.
ACIC Pharmaceutical Machinery and our partners have extensive experience in the design and commissioning of state-of-the-art equipment and turnkey solutions for the manufacture of radiopharmaceuticals.
1. FDA. Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. September 2004. https://www.fda.gov/media/71026/download
2. IAEA. Radioisotope Handling Facilities and Automation of Radioisotope Production. December 2004. https://www-pub.iaea.org/MTCD/publications/PDF/te_1430_web.pdf
3. U.S. Pharmacopeia. <1015> Automated Radiochemical Synthesis Apparatus. USP 32, NF 27, 2009. https://www.drugfuture.com/Pharmacopoeia/USP32/pub/data/v32270/usp32nf27s0_c1015.html
4. Our Partners.
This article was taken from our Radiopharmaceutical Newsletter.
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