Stevanato Group Leads First Industry Discussion Paper on Primary Container Traceability

With years of experience in unit-level traceability of containers, Stevanato Group has been the lead in drafting this document. Having a standard for the unique identification of parenteral glass containers provides a common approach to key players in the pharmaceutical supply chain. Pharma companies will benefit from production efficiency and product quality that will further improve patient safety.

Health authorities and regulators are increasingly looking for much higher levels of traceability during the manufacture of parenteral medicines. The most common processes and technologies applied to achieve compliance are now reaching their technical limitations – so new approaches are needed to deliver the traceability requirements.

The International Society for Pharmaceutical Engineering (ISPE)  recently published the Discussion Paper, Unique Identification on Primary Containers to Drive Produce Traceability & Quality. It is 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.

Modern manufacturing operations in parenteral medicines are complex processes. Being able to trace each container within the process reduces risk and enables a detailed root cause analysis to improve each process.

Stevanato Group played a key role in drafting the document, leveraging its multi-year experience in the development of its novel container traceability solution that marks each primary container with a unique machine-readable 2D data matrix barcode. Each bulk or pre-sterilized glass syringe, cartridge, and vial aggregated in nested secondary packaging is given its own ‘fingerprint’. Thanks to Stevanato Group’s high-speed visual inspection machines, marked filled containers with defects can be immediately identified and segregated.

“Primary container serialization enables pharma companies to have unit-level traceability in the key steps of their manufacturing process, avoiding batch mix-ups before labeling 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 leveling 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,” added Tod Urquhart, Product Manager and Core Team Leader at Stevanato Group.

Established in 1949, Stevanato Group is one of world’s largest, privately owned designer and producer of glass primary packaging for the pharmaceutical industry. From its outset, the Group has developed its own glass converting technology to ensure high standards of quality. The Group comprises a wide set of capabilities dedicated to serving the biopharmaceutical and diagnostic industries: from glass containers with its historical brand Ompi, to high-precision plastic diagnostic and medical components, to contract manufacturing for drug delivery devices, to vision inspection systems, assembly, and packaging equipment.

The Group also provides analytical and testing services to study container closure integrity and integration into drug delivery devices, streamlining the drug development process. Thanks to its unique approach as a one-stop-shop, Stevanato Group can offer a wide set of solutions to biopharma companies for a faster time to market and a reduced total cost of ownership. For more information, visit www.stevanatogroup.com.