Parenteral drug products are protected by appropriate primary packaging to protect against
environmental factors, including potential microbial contamination during shelf life duration. …

Dual-chamber systems provide an option as a drug and device combination product, when
home care and emergency lyophilized products are intended. Nevertheless, until today, there …

Low volume aseptic filling of parenterals, particularly monoclonal antibodies is becoming
increasingly important with the development of more and more intravitreal drugs and high …

Capping completes the closure of parenteral drug products in the final packaging container
and is critical in maintaining an integral seal to ensure product quality. Residual seal force (…

The reconstitution of freeze-dried products is usually determined by visual inspection with the
naked eye. This can inevitably lead to significant variability in the ability to detect complete …

2 ice crystals. Compared to the established process, drying times were reduced by half using
the 1 new processes. The drying time was however, longer for syringes compared to vials …

Biopharmaceuticals are often lyophilized to improve their storage stability. Controlling ice
nucleation during the freezing step of the lyophilization process is desired to increase …

… of the scaffold matrix decreased by 1 K accounted for 7.10 J for SLS nylon scaffolds, 6.95 J
for CNC alu scaffolds and 15.28 J for the SLS SS scaffolds. Compared to stainless steel, the …

Reconstitution time of dried products is influenced by various factors including formulation,
process, and reconstitution method itself. This manuscript describes factors affecting …

Biological drug Drug/device combination products products are usually filled into the primary
packaging Primary packaging container Primary packaging containers under aseptic VPHP …