Vial, QA/QC microCT - 1275
Contact Us

Fast and accurate non-destructive processes for packaging

Drug manufacturing monitoring requires efficient processes and safety and manufacturing controls in order to provide high quality, safe, active pharmaceutical ingredients (APIs) at the right dosage to patients. Pharmaceutical manufacturing requires continual monitoring and development of all aspects of the process including, filling and packaging of vials and syringes following FDA approval of a drug.

Packaging is an important component in the development of various drug formulations in the pharmaceutical industry. One area of ensuring product quality within the pharmaceutical industry is where processed powders and solutions are filled into vials and syringes and it is critical to carefully control the filling load. Contactless check weighing (CCW) is a non-destructive process already in use at Roche, using an established procedure for at-line process control for different vials and syringes using CCW to measure the filling weight of parenteral drug product solutions in vials and syringes.

In CCW, TD-NMR technology offers a convenient and quick, one-step solution. Within seconds the filling load is determined to high precision, and without the need for the sample to be removed from the vial.

Package and seal integrity for injectable drugs (Vial tops) can be just as critical as the drug formulation itself. Poor seals can allow moisture to enter the container, changing the stability of the drug and causing a decrease in efficacy. In worst-case scenarios, the patient can be exposed to contaminants or microbes resulting in a major illness or fatality.

In package and seal integrity [SG1] for injectable drugs, X-ray micro-computed tomography (μCT) is one of the most powerful methods for getting 3D insights into products and devices. It is non-destructive, requiring minimal to no sample preparation, eliminating the tedious task of embedding, coating, or thin slicing. μCT can help recognise nonconforming packaging machines, discover supplier variation in components, and isolate problematic design issues.