Moving beyond process control, and into true prevention of delamination and pH shifts

The delamination of pharmaceutical glass poses serious concerns; a potential problem that has led to a number of drug product recalls in recent years.

Like the pharmaceutical companies, Nipro PharmaPackaging puts the patient's safety and health first. This is why we invested heavily in finding the right solution to address the industry's concerns on delamination.

The VIALEX™ technology addresses the current gap of utilizing only "process control" with statistical screening in the risk reduction of delamination.

• The technology developed by Nipro R&D in Japan is able to reverse the surface effects from the converting operation.
• Tubular vials that are processed using the VIALEX™ technology offer an unprecedented surface quality with unparalleled hydrolytic resistance levels. This leads to exceptional robustness against delamination and a remarkable low pH-shift.
• No revalidation work by the pharmaceutical manufacturer is required since no foreign material is introduced through coatings or other traditional methods.

The improvements in glass surface durability generated by VIALEX™ not only greatly reduces the risk of delamination, but may potentially provide an extended shelf life or reduced need for buffers as additional benefits.

The features and benefits of the VIALEX™ technology will be presented. We will share the results obtained by applying this innovative technology and present the studies executed to date, proving the efficacy of the proprietary VIALEX™ technology.

The audience will better understand the features and benefits of the concerning VIALEX™ technology, why we developed this technology and how it can help to minimize the risk of delamination in glass vials.