Serialization is an anti counterfeiting strategy being adopted by CPGs globally. Government has begun to mandate this in certain industries. Product serialization is one approach. Firms adopting product serialization must deal with data management at an enterprise, plant and line levels. This commentary provides an approach to secondary packaging applications. Unique serial numbers are marked on the unit of sale, then the case or bundle, and finally the pallet. Aggregation of these numbers occurs at the case and pallet. The following suggests how this may be done and minimize risk.
Goods available for sale that are of high value and reasonably easy to counterfeit are the most likely targets. We see this in the pharmaceutical industry (MGS’ core market) but it is also a concern in electronics and with items like ink jet cartridges. Counterfeiting is done by highly organized crime rings using the profits to finance and expand their illegitimate operations.
Harm to the public comes in two principal ways – financial and health / safety. Consumers are duped when buying an item that may not meet the published claims. Manufacturers experience lost sales. And in the case of counterfeit pharmaceuticals, the risk to our health is potentially life threatening.
Industries’ response to secure our product channels is to adopt various anti counterfeiting strategies. Special printing, holographic foils and chemical signatures are all in current use. The global pharmaceutical community has largely adopted the application of serial identifiers (unique, non-consecutive numbers) to their products. Throughout the distribution channel this number can confirm the product is legitimate. Importantly, the end consumer can verify this as well.
The infrastructure required to implement this is significant. This barrier has delayed moving forward faster. Government has gotten involved to mandate serialization among health care products manufacturers. The governments of Turkey and Brazil are early adopters. In the U.S., the State of California passed legislation in which serialization requirements start January 1, 2015. The business case for implementing serialization on existing (and all new) packaging lines is challenging to build. Government intervention will see to it serialization happens.
Our discussion will be geared toward the use of serialization within pharmaceutical packaging operations. Generating a random, unique number for each unit of purchase (each packaging line could require hundreds of numbers for every minute of operation) is the first challenge. Beyond that, each number must be associated with each product; groups of numbers (aggregates) must be associated with other unique numbers (parent – child relationship). Then, all this data must be managed, stored and made available well into the future.
Both plant and line level information systems must be in place and equipped to deal with this data. There are a number of firms and partnerships in the marketplace providing solutions for this. Our discussion will be centered on implementation at the packaging line level and how it can best be configured to provide accurate data to the line level information system.
It has become customary to apply the first or lowest level of serial identifier on the unit of sale. Commonly, this is either a bottle or carton. In few instances, it has been considered to apply serialization at an earlier level, such as a blister, vial, pouch or even a tablet. Our requested implementations have only been at the unit of sale as the lowest or first lead thus far.
Our discussion will center on applying the unique serial number to the carton, then case and finally the pallet.
Applying a serial number to the carton
Cartons have allowed space and location for printing or labeling that gives data on the lot and expiration date for many years. Adding a serial number to this means allowing for the necessary space to apply it. It may also require an upgrade printer technology.
Typically the serial number is applied in a machine-readable format, with the 2D code being chief among those. The 2D code is small, can be printed with either a laser or ink jet printer and has the ability to contain a lot of data. A few years ago, we saw RFID tags being considered, but have not been widely commercialized largely due to the unit cost.
It can be challenging to add a printing head and a vision camera or scanner inside of a cartoner. This creates a lot of clutter in and around the area of carton flap closing, a common area of cartoner failure. So clearing jams and cleaning the machine becomes problematic.
We recommend a small, separate print, verification and reject module be added to the line immediately downstream of the cartoner. This keeps these functions discrete and separate from the customer and easier to manage. Also, some of the modules can have lockable bins that insure rejects are not added back to the line by operations or other personnel.
It’s critical this module maintain positive control of the carton to insure high quality printing, particularly the case with 2D codes. Otherwise, unnecessary rejects will occur. Also, the carton can be inspected for open flaps prior to being conveyed to the casepacker or bundling machine, eliminating a potential jam and line stoppage.
Applying a serial number to the case or bundle
This is where the first level of aggregation occurs (all cartons in the case or bundle are now tied to a new, unique, single serial number). Where another, new unique number is issued and all the serial numbers for each carton are associated with it (parent – child relationship).
Each carton serial number is read by a scanner or vision camera and collected by the line monitoring system. Then, the new serial number for the case or bundle is issued. In some equipment, it’s possible to scan the collated cartons all at one time just prior to loading the case or wrapping the bundle. We recommend this as it provides additional assurance of which cartons actually make it into the case or bundle.
At this point, the case or bundle is now assigned a unique serial number. The line monitoring system must store this data and track it until the next function of the packaging line is performed. Typically this is palletizing, the last function on the packaging line.
Applying a serial number to the pallet
Each case or bundle having its unique serial number now arrives at the palletizing operation. Just prior to this, often we are asked to apply a label to the case or bundle displaying its 2D code.
With some line monitoring systems, it is also possible to print this label and include printing the serial number in human-readable format. Also possible, is to print the serial numbers for each carton included in the case or bundle in human-readable characters. This makes a user-friendly system.
Once the label is applied, the case is added to the pallet, either manually or via an automatic palletizing machine. A new, second level of aggregation takes place. All cases or bundles are now tied to another, new, unique serial number. Now the function of the packaging line is complete.
MGS Machine serves the pharmaceutical market with its automated packaging machinery solutions. We have over 14,000 successful installations in 27 countries around the world. Our main campus is located in Maple Grove, MNUSA. We work with pharmaceutical manufacturers and their contract packaging suppliers to implement serialized secondary packaging lines.
MGS Machine Corporation
9900 85th Ave N.
Maple Grove, MNUSA 55369