The ISPE recently published the discussion paper, Unique Identification on Primary Containers to Drive Produce Traceability & Quality. It’s the outcome of a collaboration with a working group lead by the Stevanato Group, which includes pharmaceutical companies, contract manufacturing organizations (CMOs), fill & finish machine manufacturers, inspection machine producers, and a software company.
The document outlines the current implementation of unique container identification technology in parenteral manufacturing lines, including potential solutions, and a summary of the challenges technology developers face to develop and implement solutions within their operations.
Being able to trace each container within manufacturing operations reduces risk and enables a detailed root cause analysis to improve each process.
Stevanato Group has developed container traceability solution that marks each primary container with a machine-readable 2D data matrix barcode. Each bulk or pre-sterilised glass syringe, cartridge, and vial aggregated in nested secondary packaging is given its own 'fingerprint'. Using the group’s visual inspection machines, marked filled containers with defects can be identified and segregated.
“Primary container serialisation enables pharma companies to have unit-level traceability in the key steps of their manufacturing process, avoiding batch mix-ups before labelling and limiting batch segregation in the event of a problem, which often result in lost or missed revenue," said Fabio Bertacchini, Product Management Director at Stevanato Group.
"With this document, Stevanato Group is levelling the playing field of primary serialization to facilitate its implementation by the industry. As many of the existing technologies are closed due to IP ownership, our goal is to create an open-source solution that could benefit all. To do that, we are working with multiple stakeholders to remove any possible barriers to entry and implement solutions that minimize any impact on existing processes," said Tod Urquhart, Product Manager and Core Team Leader at Stevanato Group.