The Drug Supply Chain Security Act – DSCSA (Title II, Drug Quality and Security Act, 2013) –has been signed into law and represents significant changes for U.S. pharmaceutical manufacturers. Full implementation of the Act is to be phased in over the next 10 years, with several modifications to packaging standards in the pharmaceutical industry expected. The next pivotal deadline, November, 2018, is approaching, requiring all pharmaceutical manufacturers to print unique product identification codes on all Rx units of sale, and any homogenous cases distributed domestically.
With just over one year left to be compliant, the U.S. pharmaceutical industry is at varied levels of preparation for the upcoming serialization mandates. Some major pharmaceutical and biopharmaceutical companies have gotten a leg up on others, already serializing some of their lines, or piloting with trading partners. Unfortunately, though, a majority of the large and mid-sized pharma corporations are just now in the beginning phases of drafting RFPs and strategy development. And with a typical timeline of 24 to 36 months to develop, implement, and pilot an operative strategy via a viable trading partner connection, many of these companies will have a difficult time complying by the deadline. Serpa, a world leader in packaging solutions, is providing a semi-automated case packing solution with an incredibly short lead time that can help pharmaceutical customers meet the deadline for serialization.
Incorporating years of extensive knowledge and expertise of both fully and semi-automated case packers, Serpa developed this machine as a lower cost option for those unable to afford a fully automated case packer. With its ModPack modules, customers use only those modules necessary to complete their respective projects, and the universal camera mount allows ModPack compatibility with all serialization and vision systems. The flexible, modular design of this unit allows for fast, efficient change overs, and the labeler “swings” open for easy operator and maintenance access to the load station, or the front and back of the labeler. It is the most compact footprint available on the market today, with unique collators designed to handle bottles, cartons & bundles.
The Serpa semi-automated case packing solution is the ideal choice for fast and reliable implementation, with quick lead times to meet customer serialization project deadlines and comply with the DSCSA packaging deadline of November, 2018.
Serpa Packaging provides an extensive array of custom solutions for the Pharmaceutical and Medical Device industries. To learn more about their innovative products and more about the DSCSA changes to pharmaceutical packaging standards, visit http://www.serpapackaging.com/products/pharma/.
One of the biggest headaches in manufacturing is having different OEMs for critical production equipment resulting in inevitable integration challenges. Different standards implemented from OEM to OEM create a huge hurdle for integration, and often, the integrator is not the manufacturer of the machines on a line. Without a fully integrated line from a machinery manufacturer, lack of oversight between different vendors leads to finger pointing when downtime occurs.
There are a multitude of benefits, however, of incorporating one project manager and integrator to an entire line. Equipment commonality is increased and timelines are greatly reduced. It also saves time and money during the FAT as engineers can review all equipment issues during one visit to a single site. Plus, having one OEM both manufacture and integrate the equipment leads to a more robust manufacturing protocol due to better equipment commonality and standardized practices with faster recoveries.
While a completely integrated packaging line may include several different types of machines, poor integration can lead to a multitude of problems resulting in unplanned downtime and unforeseen costs. But Serpa Packaging Solutions offers fully integrated lines utilizing less equipment from other manufacturers to do the same job as third-party designs from other OEMs. This can lead to a smaller manufacturing footprint that allows for future flexibility and reduced downtime. Serpa’s automatic and rapid changeover solutions have been critical to their success, and since they engineer every transfer and use only high-quality parts, service expenses can be minimized and production availability is increased. To top all of that off, Serpa is the only U.S. manufacturer able to provide engineered solutions superior to those available from European manufacturers, with shorter lead times and increased service responsiveness.
Serpa Packaging Solutions is an industry leader offering completely integrated packaging lines for very diverse applications within a variety of industries, and currently maintains a major presence in the pharmaceutical, food, medical device, personal care, cosmetics, dairy, and household sectors. While most manufacturing industries use continuous operations combined with advanced process control and automation to drive quality and repeatability, most manufacturing has relied on fixed-recipe batch technologies for more than a century. But batch manufacturing can be a very lengthy and expensive process which can result in huge yield losses from any type of unexpected deviation. However, Serpa’s fully integrated packaging lines have generated a new manufacturing paradigm for these industries, with products being delivered to consumers much quicker, at significantly reduced cost, with consistent high quality and yields.
Serpa’s mission is to become the end-of-line packaging company of choice by not only providing the most advanced technology, but by also establishing long-term relationships with their customers. To learn more about Serpa’s cutting edge innovations and how to maximize your packaging lines to reduce downtime while increasing quality, visit Serpapackaging.com