Solutions for radiopharmaceuticals

Washing Reusable Parts with Radioactive-Effluent Management.

The parts washer removes product, chemical and radioactive residues through a repeatable cleaning process. Generated wastewater follows a dedicated route to collection and decay storage rather than the conventional drain. Retention is defined according to radionuclide half-life, initial activity, dilution, tank capacity and production frequency. Level monitoring, alarms and sampling or activity verification support traceable discharge only after the site’s authorized criteria are met.

Pass-through parts autoclave to deliver sterile components toward the classified filling area.

After washing, reusable product-contact components undergo a validated saturated-steam cycle. A pass-through configuration separates the preparation side from the classified side and enables unloading toward the hot cell or shielded isolator. This protects the controlled status of the parts, reduces open handling before use and provides traceable cycle evidence before components enter the time-critical filling process across the classified interface.

Remove the intermediate transfer between cleaning and sterilization.

This configuration removes an intermediate equipment interface and limits transfers of contaminated or cleaned components. For radiopharmaceutical applications, radioactive wash effluents must still follow their controlled collection and decay route. The choice between combined and separate systems depends on load, capacity, scheduling, exposure, classified-space requirements and required system availability.

Terminal sterilization is integrated after filling, closing, seal inspection and activity measurement. The cycle is developed around product stability, container behaviour, required lethality and radiological constraints. Automated loading and unloading connect the autoclave with subsequent inspection, shielding, labelling and packaging, supporting rapid downstream progression within the shielded production flow without treating sterilization as an isolated operation.

The rapid growth of biologics, nanoparticle-based medicines and Advanced Therapy Medicinal Products (ATMPs) is redefining the relationship between pharmaceutical formulations and primary packaging.
Interactions between proteins such as insulin, nanoparticles and container surfaces are well-recognised phenomena that can influence product stability, efficacy and patient safety. As these therapies become increasingly sensitive, material compatibility can no longer be considered an intrinsic property of the container alone.

When manufacturers seek to move away from EtO towards a method that reduces toxic-residue concerns and the potential burden on patients, workers and the environment, selecting an alternative sterilant is only the beginning.
This is particularly true for the low-temperature sterilization of RTU glass vials in their complete packaging configuration. The sterilant must pass through the outer transport box, multiple porous barriers and enclosed packaging interfaces before reaching the internal vial surfaces. The same structure must then release residual sterilant within an acceptable aeration time.