Data is the Driver For Small Pharma Manufacturers
By Sean Riley, PMMI, Editorial Director
Small pharma manufacturers can use existing automation to help meet evolving pharma regulations.
When government oversight adds additional regulations and requirements for compliance, small pharma manufacturers often suffer the most, as they don’t have the capital resources in place to adapt to new directives. With automation already incorporated into more and more lines, however, small manufacturers can use their existing footprints to bring their operations up to spec.
The introduction of the Drug Quality and Security Act (DQSA) created a national regulation for pharmaceutical serialization and track and trace, requiring primary and secondary packaging of pharmaceutical goods to have serialized coding.
Signed into law by President Obama in 2013, Title II of DQSA, the Drug Supply Chain Security Act outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs through distribution in the United States. Ten years after enactment, the system will facilitate the exchange of information at the individual package level, about where a drug has been in the supply chain.
What does this mean for pharma manufacturers and, in particular, smaller companies?
While the cost of integrating serialization and track and trace solutions into the packaging line is a concern, small pharma manufacturers understand serialization standards are inevitable. What they seek from their packaging OEMs are solutions to help meet compliance and guidance on how to implementation those solutions.
Previously these regulations mainly came down from the state level, allowing many small manufacturers a reprieve. Now, however, without a clear picture of how the regulatory landscape will shake out on this issue, not only in the U.S. but also globally, small manufacturers need to be prepared when the DQSA comes into force in 2017.
Now in its third iteration, Pharma EXPO 2016 (McCormick Place, Chicago; Nov. 6-9) is the hub for small pharmaceutical manufacturers seeking solutions to comply with this and other regulations. Co-produced by PMMI, The Association for Packaging and Processing Technologies, and the International Society for Pharmaceutical Engineering (ISPE), and co-located with PMMI’s PACK EXPO International, Pharma EXPO will provide a forum where small manufacturers in the pharmaceutical, nutraceutical, biopharmaceutical and medical device sectors can learn about the latest regulations and sophisticated technologies.
Pharma EXPO will also offer educational sessions via the Innovation Stages, Pharma EXPO Live and the Pharma EXPO Conference Program, organized by ISPE.
Real Time Data
As with any sweeping legislation that encompasses an entire industry, the DQSA is confusing to many pharma manufacturers, big and small, just as the Food Safety Modernization Act was/is to food producers, processors and packagers. Pharma does not yet have a handle on how DQSA regulations will affect their plant floors. For the manufacturers that do understand the law, applying it is easier said than done when it comes to their packaging machinery needs.
As a result, pharma and medical device manufacturers are looking to OEMs for equipment to help keep pace with the changes taking place in the industry. For OEMs, that means delivering equipment and solutions that provide manufacturers with a consistency of operations across all their plants and machine performance analytics that allow for back office integration.
In addition, manufacturers expect OEMs to build equipment that is compatible not only with FDA regulations but international quality and consumer safety standards.
Given the uncertainty surrounding serialization, it is not surprising that manufacturers are looking to OEMs to help them find solutions for collecting and aggregating serialized data across the supply chain.
Just as in other packaged goods industries, pharma manufacturers expect OEMs to be partners; a company they can rely on to guide them on how best to set up packaging lines to help them when it comes to impending serialization laws and regulations and provide equipment that increases operating efficiency and plant productivity.
As packaging machinery becomes more automated, the capability to capture real-time analytics increases. Getting to the data, however, starts with flexible ways of integrating systems. PACK EXPO Las Vegas and Pharma Expo 2015 (Las Vegas Convention Center, Sept. 28-30), offered many ways to mine and organize this critical data.
Rockwell Automation showcased its RAPID software program that uses a common equipment interface and a repeatable approach to configure, control and analyze line performance from a standard operator station. Previously, integration required hard-wiring, but RAPID works from the inside out, using instruction sets within the software. These data hooks evaluate machine performance for overall equipment effectiveness (OEE), and can provide real-time historical information, advanced analytics and custom reporting.
Pro Mach used the opportunity of PACK EXPO Las Vegas to introduce ProTech. This suite of remote connectivity and software solutions for both proactive and reactive maintenance provides remote monitoring, downtime and OEE tracking, and a customer portal that enables customers to keep track of line performance offsite. ProTech works across all twenty-plus of ProMach’s packaging machinery brands.
The Script Pack SPrint system from Automated Packaging Systems and Rx Automation offered a unique all-in-one solution for mail order pharma.
The Script Pack Sprint—which includes vision systems from Cognex, a digital printer from Xerox, and label printing from Videojet—could be a game changer from both labor reduction and accuracy-in-packaging standpoints. It combines Rx vial scanning, digital document printing, document verification, document folding, document scanning for re-verification, insertion of vial and paperwork into a bag, label printing and bagging.
These are just some of the litany of solutions small pharma manufacturers will find available to them at Pharma EXPO 2015.
Attendee registration for PACK EXPO International and Pharma EXPO opens in February 2016. Learn more.
About PMMI
PMMI, The Association for Packaging and Processing Technologies, represents the voice of more than 700 North American manufacturers of equipment, components and materials for processing and packaging. We work to advance a variety of industries by connecting consumer goods companies with manufacturing solutions through the world class PACK EXPO portfolio of trade shows, leading trade media and a wide range of resources to empower our members. The PACK EXPO trade shows unite the world of processing and packaging to advance the industries they serve: PACK EXPO International, PACK EXPO Las Vegas, Pharma EXPO, PACK EXPO East, EXPO PACK México, EXPO PACK Guadalajara and ProFood Tech, launching in April 2017.PMMI Media Group connects manufacturers to the latest solutions, trends and innovations in processing and packaging year-round through brands including Packaging World, Automation World, Healthcare Packaging, Contract Packaging and Packaging + Processing OEM. PMMI Business Drivers assist members in pursuing operational excellence through workforce development initiatives, deliver actionable business intelligence on economic, market and industry trends to support members’ growth strategies, and actively connect the supply chain throughout the year. Learn more at PACKEXPO.com, PMMIMediaGroup.com and PMMI.org.