PETTEN – New essential analysis equipment for Quality Control has been installed in FIELD-LAB. This equipment will be used to perform measurements on isotopes, produced by FIELD-LAB in the near future, to establish if the isotope is up to GMP (Good Manufacturing Practice) standards and, consequently, can be used in patients.

Isotope products (Active Pharmaceutical Ingredients) are used for therapy and diagnosis of patients with certain types of cancer. These products enter the patient's bloodstream directly and must therefore meet very strict GMP requirements.

To meet these requirements, quality control measurements must be performed by the department QC FIELD-LAB. The products will be tested for radiochemical and radionuclidic purity, absence of metals, content of endotoxins and pH. This needs to be documented and must be upheld as with a new drug.

All necessary analysis equipment is now installed in FIELD-LAB and our other facilities. This is a major milestone. The coming period will be used to validate the analysis equipment under GMP conditions and to get various documentation in order.