MGS Machine introduces their new line level serialization solutions for pharmaceuticals. In collaboration with INEL, MGS offers customized turnkey solutions for serialization and aggregation to enable product manufacturers and contract packers to quickly and easily comply with regulatory requirements for track-and-trace initiatives. In addition to helping ensure consumer safety by authenticating product pedigree, these serialization offerings protect brand integrity and limit the risk of product recalls, litigation and settlements.
Line level serialization is achieved by integrating a unit level packaging machine with software that assigns unique numbers to these units of sale and manages this data on a line level, along with a printer that marks the codes on the units of sale and a vision system that verifies the codes are compliant. Options to aggregate these serialized units to a case packer and palletizer create child-parent-grandparent relationships. The software tracks all relevant data, managing all the numbers including those associated with products that are rejected, reworked and reintroduced. These line level systems are designed to easily interface with customers’ site servers and enterprise systems.
Using a thermal inkjet or laser printer to print unique 2D codes and the four lines of alphanumeric text required by U.S. serialization legislation, or other formats required elsewhere, unique codes are marked on each unit of sale. A camera-based vision system then verifies the codes and either allows the product to continue down the line or triggers an automated reject device. An optional tamper-evident label applicator and/or checkweigher further help ensure product quality.
With many different secondary packaging solutions available from MGS and a multitude of other options, these line level serialization solutions can be designed to accommodate virtually every situation. Capable of packaging and serializing at rates of up to 400/min, systems can handle a wide range of product sizes and styles with fast, recipe-driven, tool-less changeover.
Turnkey MGS solutions are also available for customers requiring aggregation of the serialized products, now or in the future, into cases and pallets to create child-parent-grandparent relationships. Fully automated aggregation systems use an MGS case packer and robotic palletizer while semi-automated solutions use aggregation stations. Both automated and semi-automated aggregation systems integrate the line level software with print-and-apply labelers to generate and affix unique labels to cases and pallets and vision systems to verify the validity of the labels.
“It’s estimated that there are 22,000 pharmaceutical packaging lines in the U.S. that need to comply with the FDA’s ‘Drug Quality and Security Act,’ which requires serialization by November 27, 2017. These product manufacturers and contract packers need a trusted supplier with the expertise and agility to quickly customize and deliver the ideal serialization solutions for their applications,” says Richard Bahr, President and CEO at MGS Machine.
MGS offers a “total solution” approach that includes full IQ / OQ validation support. World-class aftersales service includes standard and extended warranties, preventative maintenance programs and onsite installation, training and ongoing service.
![“Another key [UDI] benefit, because we're calling that product by the same name across the healthcare supply chain… rich and robust data that we can access around supply consumption and utilization rates. One of the buzz terms we've heard during the COVID-19 crisis was what's my burn rate? How fast am I going through gowns, masks, gloves?” – Mike Schiller, Senior Director at AHRMM](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2020/08/UDI.5f4d326e41d53.png?auto=format&fit=crop&h=146&w=340)
