Working according to GMP guidelines
MCPL’s new hot cell installation complies with all European standards and regulations. From the start, the customer insisted on working according to GMP guidelines. These guidelines provide requirements for manufacturers to assure that their products are consistently high in quality. In Europe, this is standard for the production and sale of radiopharmaceutical products, but not yet mandatory in India.
Dr. Ajith, Owner of MCPL: “Our organization wanted to establish the best commercial cyclotron facility in India. With the EU GMP standards we ensured the quality in radiopharmaceutical production and radiation safety for the staff and working environment.” MCPL is the first radiopharmaceutical company in India to do so. Their installation is also futureproof, because it’s probably a matter of time before the Indian government requires working according to GMP guidelines too.
The dispensing hot cell is connected to an active gas compression system with storage tanks.
A national standard for active gas compression
The dispensing hot cell is connected to an active gas compression system with storage tanks. This is rather unique in Europe, but mandatory in India. The system prevents radioactive particles from leaving the hot cell via the exhaust system. The air from the hot cell is compressed and placed in a gas tank. The collected gas is stored for radioactive decay and released after 10 half-lives. The buffer tanks are installed in the same room as the cyclotron that generates the radioactivity.
Dr. Ajith: “This process is quite new in India and the Atomic Energy Regulatory Board (AERB), an Indian government organization that carries out regulatory duties and safety functions according to the Atomic Energy Act, used our installation as a model for other cyclotron centres across the country.”
Along with routine FDG production, MCPL is also using the hot cell installation to produce other F-18 radiopharmaceuticals, like F-PSMA, F-Choline, FDOPA, FET, FMISO and NaF. [name]: “The installation is user-friendly, and the dose rates are well controlled during production. The required maintenance is minimal; the parts are easily accessible and simple to clean. The hot cells meet all of our requirements without compromising radiation safety.”
The benefits of our active gas compression system:
- Prevents contaminated air to be released into the atmosphere
- Controlled through the hot cell interface
- Low maintenance compressor
If you have similar needs for your laboratory, please do not hesitate to discuss the possibilities with us.