By Oliver Stauffer, CEO, PTI Inspection Systems and Jeff Morrow-Lucas, Principal Engineer, Helium Technologies, PTI Inspection Systems
The COVID-19 pandemic has highlighted many of the challenges facing the pharmaceutical industry, among them the importance of distribution logistics. Along with COVID and other vaccines, pharma has seen a dramatic increase in the production of cell and gene therapy treatments, biologics, and other large-molecule products. Many of these require unique storage conditions to ensure the safety and efficacy of the drug, and container performance during the cold chain is of particular concern.
Some of the most novel products are now filled and sealed in combination devices. Since the components must function together, design and distribution considerations are critical to the early design of both the drug and the container. Fill-finish quality and container performance in cryogenic distribution are areas where the industry can improve rapidly, through new container design supported by the most sensitive container testing methods.
Helium leak detection technology is widely available, most everyone in the industry is familiar with it, and it is generally regarded as the most effective means of ensuring container integrity. Yet, many manufacturers still only use it sparingly or not at all because of its complexity compared to less reliable methods. Utilizing helium detection early in development is a sensible solution that companies can apply immediately to make profound improvements in the quality of their drug delivery system design for the complete container life cycle. Doing so will save time and money while raising the standard of safety.