Staying Ahead of New Statutes

Oct. 5, 2016
Impending serialization regulations are driving trends in pharma

As key target dates in the federal regulation of the pharmaceutical industry approach in the next year, processors and manufacturers are exhausting all options for information on new technologies or innovation that will help them pass muster.

The next of many big deadlines from the Drug Quality and Security Act (H.R. 3204), specifically Title II of the law, requires manufacturers to put unique product identifiers on prescription drug packages by November 2017. This includes a National Drug Code (NDC), a serial number, a lot number and an expiration date. (Repackagers face the same requirements in 2018, wholesale distributors in 2019, and dispersers by 2020. Enhanced product tracing at the package-level will be required by 2023.)

Pharma EXPO (McCormick Place, Chicago; Nov. 6-9, 2016), co-located with PACK EXPO International and co-produced by PMMI, The Association for Processing and Packaging Technologies, and the International Society for Pharmaceutical Engineering (ISPE), provides a forum for education sessions on the latest technologies in serialization and aggregation. Among more than 80 education sessions are free seminars and paid offerings about the latest breakthroughs and real-world case studies.

For example, experts from SEA Vision will discuss “Coping with Serialization Regulatory: A Fully-Adaptable Solution for Pharmaceutical Companies and OEMs Worldwide.” This overview of the compound and multi-challenging serialization regulatory landscape will help attendees address serialization needs.

In a similar vein, Antares Vision’s session offers a spirited overview of the exhaustive yet educational process of incorporating modern-day track and trace systems. “Serialization Implementation: Key Challenges and Lessons” details the compromise between line integration and standalone modules according to space, availability, ease, reliability and speed of format changeover.

At the Pharma EXPO Conference, “Serialization – Regulatory Compliance” will investigate the latest industry interpretations for serialization strategy and regulatory compliance. Participants will understand what you can do now to accelerate your implementation; what worked and what can be improved; and discuss the latest industry interpretations for serialization strategy and regulatory guidance to meet the deadlines and how downstream requirements are impacting policy.

Pharma EXPO also offers pharma, biopharma, medical device, personal care and nutraceutical manufacturing professionals over 250 top-tier suppliers serving the pharmaceutical supply chain. A short walk from the West Building of McCormick Place to its South Building takes you to PACK EXPO International, where attendees can peruse opportunities for a cross-pollination of processing and packaging solutions from 2,000+ exhibitors serving a variety of industries.

The following are just a few examples of equipment and technologies that will be on display: 

SencorpWhite will showcase its APM/APS automated pouch sealing system — an ideal solution for medical device manufacturers and contract manufacturers challenged with Unique Device Identification (UDI) compliance and increasing FDA pressure for risk mitigation.

VAC-U-MAX powder and granular handling systems continuously process powders, additives, fillers and granular materials to processing, packaging and refill machines. The system minimizes exposure to fugitive dusts, providing safer plant environments — especially where combustible dusts are handled.

Weiler Labeling Systems will introduce its new label serialization — a system that offers a fully integrated solution in which bottles will be pre-coded with unique 2D Data Matrix tracking codes while being transported on a rotary platform.

Atlas Material Testing Technology will introduce The Suntest XLS+, a complete photostability testing solution. An advanced and cost-efficient instrument, it provides faster test times, superior uniformity, full UV and visible spectrum, and a smaller footprint. Additionally, Atlas has combined the Suntest XLS+ unit with a complete package that provides all of the items required to meet The International Council for Harmonization (ICH) specification including air chiller to provide realistic testing temperatures, filters for both confirmatory and forced degradation studies, sample holders and more.

NJM Packaging’s new Dara Moduline Model NFL system seamlessly integrates Dara’s aseptic fill-and-finish system with Getinge La Calhene’s isolator technology to achieve a class 100 cleanroom working environment when operating the system in a class 100,000 cleanroom. By designing the top plate of the filler into the isolator and manufacturing them simultaneously rather than sequentially, Dara speeds delivery and reduces capital costs. Moduline is a family of compact and modular solutions for filling liquids and powders into vials, syringes and cartridges. It is ideal for small-scale clinical trials and mass production of a wide range of pharmaceuticals and biopharmaceuticals, including lyophilized products. 

For more information or to register for this year’s Pharma EXPO, visit

About the Author

Sean M. Riley | Editorial Director