“PCI has invested substantially in serialization capacity over the past three years and the latest capital investment will triple its available capacity, adding both integrated Serialization equipment as well as stand-alone FlexSuite equipment,” Justin Schroeder, a PCI representative, told us.
The investment allows clients who may need serialization as a finishing solution for goods packaged without serialization and need to be compliant to the November DSCSA requirements.
Schroeder explained the investment also positions PCI to support demand increases for ex-US markets, including the upcoming FMD requirements in Europe as well as evolving requirements in emerging markets including Brazil, China, South Korea, Turkey, and others.
In additional to increasing its serialization capacity, PCI has concurrently grown its serialization team by four-fold since 2015.
The pharmaceutical services company partnered with Antares Vision, Marchesini, and Domino for the multi-site installations, which support various drug delivery forms, including bottles, unit cartons, and parenteral kits, in addition to unit dose wallets and child resistant/compliance prompting packaging.
The company is also supported by Xyntek in the US.
“Having a dual-sourced solution helped PCI stay ahead of the increasing demand for Serialization equipment and lead times due to the market pressures brought on by the need for November 2017 readiness,” Schroeder said.
Preparing for November
PCI has hosted geographically focused Serialization Forum events in the US and Europe over the past 18 months and, as Schroeder explained, has consistently seen that less than 40% of the market is ready for the November deadline.
“There is a bit of a mad rush in the market for pharmaceutical companies to get prepared for November,” said Schroeder. “It is crunch time for meeting the November deadlines from a supply chain perspective and there is considerable activity in the market.”
PCI has follow-on investments planned as it looks to finalize its Serialization infrastructure.
Schroeder also noted the European FMD requirement looms in 2019.
“From a supply chain perspective, that itself is not far away and client activity is ramping up significantly to meet those requirements including the EU specific demand for incorporating Tamper Evident features,” he said.