The Cellular Labeling in Nuclear Medicine are classified by Good Radiopharmacy Practice Standards in the Preparation of Radiopharmaceuticals in Nuclear Medicine as “extemporaneous preparations” and must be carried out in a laminar flow hood (Class A) located in a Class B environment, or within an isolator, which can maintain sterility, located in a Class D environment.
The second solution avoids having to set up a cleanroom within the Nuclear Medicine Department and guarantees full protection of the product and operator.
The labeling operations are carried out inside the box, thanks to a pair of gloves found on the main wall. The material passes through the pre-chamber (in Class B) for the main chamber to never be in direct communication with the external environment.
Highlights
Modular design and flexible configuration
7” touch-screen operator panel to check and trace the critical parameters of the machine both in “at rest” or “in operation” mode.
DOP test connections (filter leakage test).
The handling environment, just like the pre-chamber, is in negative pressure with respect to the external environment, thereby ensuring compliance with the Radiation Protection Standards.
All the operations, normally performed within an area in the Nuclear Medicine Department intended for cellular markings, are summarised inside the isolator.
All the production phases can be monitored closely with maximum protection through the large windows.
The cleaning operations at the end of the cycle can be performed with the gloves, whereas the front wall of the work chamber can be opened completely in order to facilitate maintenance operations.