Overview
As concern over issues such as product recalls, tampering, and counterfeits grow, manufacturers are seeking to implement serialization and tracking mechanisms to protect both their products and their consumers. Few manufacturing companies can afford not to worry about these issues: it is a big concern in electronics, cosmetics, foodstuffs, and other industries, but it is a particularly important issue in pharmaceuticals, as the United States Government has announced it is enforcing the Drug Supply Chain Security Act (DSCSA), originally adopted in 2013, and mandating product serialization and tracking.
The Challenge
The DSCSA demands strict accountability for drug serialization and tracking to protect consumers from stolen, counterfeit, contaminated, or otherwise compromised drugs. The standards apply to distributors and logistics providers as well as manufacturers, and the Federal government requires licensing and reporting to the FDA annually
In order to be in compliance, manufacturers and packagers need to provide unique product identifiers (for example, bar codes) on their packages; be able to identify each individual who handled the drug each time it’s sold in the United States; verify the product identifier on the packages; identify and quarantine suspect packages; and notify the FDA when they find tainted or fraudulent product.
Given the seriousness of the issue, the government established severe penalties for ignoring or violating the act. Companies can be fined up to $500,000; individuals can be imprisoned
There have been a number of attempts to provide serialization and tracking solutions for existing product lines. The difficulty such initiatives present, however, is that existing systems were not designed to institute serialization on the production line – companies often need to turn to add-on solutions requiring additional hardware, repurposed plant space, and extended processes. For example, it’s not unusual to find companies moving completed product to a newly specialized “serialization area” to catalog product dates, lots, and serial numbers. Results of such hardware-based solutions have been mixed: new hardware has proven expensive, and some of the controlling software has not performed well.
This case study concerns a contractor who packs product for a number of major pharmaceutical firms: they receive bulk product and bundle it in various forms for final distribution and sale. The company had commissioned a hardware-based tracking and serialization solution from another company, but that solution failed. The packaging contractor contacted Adents, makers of a software-based solution, who recommended Avanceon as their implementation partner.
Analysis
Avanceon originally expected that the client would require tracking and serialization for a single production line, but that did not turn out to be the case. There were, in fact, multiple lines requiring different types of packaging and serialization, each of which required individual analysis, and each of which presented its own challenges. For example, the Avanceon team had to determine the serialization requirements presented by each line – how each product would be separated and distributed and whether it would require serialization by individual bottles, cartons, aggregated cases, pallets, or whatever. The team also had to consider the “speed” of the serialization – how each process would accept or reject items. A particularly important consideration was to analyze why the original solution designers had failed and determine how to integrate and communicate with existing hardware or hardware purchased for the failed solution– the customer definitely did not want to purchase new devices. This was a particularly knotty problem, as the client had not standardized on equipment: the hardware differed substantially across the first two production lines. In addition, given that the client packages nearly 20 million pharmaceutical products annually, any solution needed to be implemented via a centralized, site-level configuration and with a minimal amount of downtime.
The Avanceon Solution
In the failed solution, product needed to be moved to a holding area for the serialization to take place. In the Adents/Avanceon solution, all serialization steps are carried out inline with the packaging process on the existing manufacturing line. The packaged product comes off the line fully serialized and traceable, and no temporary storage is required.
While the Adents software is hardware agnostic, the customer’s non-standardized hardware in the first two lines required individual configurations. Avanceon successfully configured the first two lines and but also suggested the customer standardize on hardware for their additional lines. Based on Avanceon’s recommendations, the customer has now adopted standardized cameras, scanners and printers.
The customer will now also be able to take advantage of the software’s ability to minimize repetitive qualification and validation processes for new projects and/or clients. As the software includes Instrumentation Qualification (IQ) and Operational Qualification (OQ) routines for client facilities, the customer will only need to dedicate resources to the Process Qualification procedure. Finally, the Adents software can accommodate most of the necessary documentation request for quality purposes.
A key success factor on the project was the implementation of a test-bed serialization system. This system was similar to the server that controls production: this allowed the customer to carry out tests and analyses before going live with additional production lines. This is a highly recommended addition for any facility handling multiple lines at a single site.
With the addition of this functionality the customer has been able to meet all federal and customer serialization requirements now and in the future, as the Adents solution provides all components necessary to support quality assurance activities throughout the serialization system lifecycle.
The Team
The Avanceon team originally involved an account manager and two experienced senior staffers: a validation expert and a project manager. As work progressed, we added a controls engineer and an electrical design engineer. Additional controls engineers were added as the project expanded to multiple production lines. Now that configuration and installation has proven successful, the client is doing its own validation.
Result
As the deadline for serialization has passed, it’s a critical to consider the challenge of designing and implement a successful serialization solution, especially if the solution requires leveraging existing packaging line hardware. The decision of which integrator to choose becomes pivotal in the project’s path. Avanceon has had the benefit of being a foundational Adents serialization implementation partner since 2016 and, as a result, has implemented Adents solutions for many numerous clients, through those experiences, we have had the honor of being the first United States company to complete a validated, FDA compliant Adents-based serialization solution. With those successes we look forward to the opportunity to continue to leverage our experience and expertise in serialization with further life science and medical device manufacturers that look for help in compliance.
For more information on Avanceon’s serialization services, please view our serialization web page.
Image Source: Adents.com