When you are creating pure, high quality radiolabeled compounds, you need to hold your production process to the absolute highest material and clean room standards possible. There is a reason Moravek was given two large grants by the National Institutes of Health — it is due to strict adherence to Good Manufacturing Practice, or GMP.
The GMP quality control system does not simply cover the manufacturing processes themselves; it dictates every step and every element of the production. These guidelines must be strictly followed and documented to ensure the utmost consistency. The following parts of the production process are all informed by Good Manufacturing Practice standards:
Top notch equipment is an essential component of the manufacturing of radiolabeled compounds. Not only that, but the equipment must be extremely well-maintained. It must be “visually clean,” and be cleaned at intervals sufficiently frequent as to prevent any buildup of contaminants.
- Buildings and Facilities
According to GMP quality control standards, buildings which house the production of Active Pharmaceutical Ingredients (API) must incorporate the principles of quality risk management. This means that the facilities and their controls need to be designed with containment in mind, taking into account the specific properties of the raw materials being used and the final products which will result. With advances such as electronic humidity sensing devices, clean room parameters are very carefully controlled.
In order to adhere to GMP quality control standards, it is not enough simply to design a proper training program. The training must also be assessed periodically to ensure that personnel continue to operate at the standards initially imposed. If the performance slips even just a small amount, additional trainings or a greater training frequency may need to be introduced. And since the industry is constantly evolving, it is essential that all training is updated accordingly.
At Moravek, the Good Manufacturing Practice guidelines are followed religiously. This is why the company has achieved the success and longevity it enjoys today — there are no circumstances under which there would be a compromise of these high standards. To this day, Moravek remains a trusted name in the production of the Carbon 14 isotope and other useful compounds.