To me, the most surprising thing about pharmaceutical traceability is that there hasn’t been a solid system in place for years. With the industry having to deal with recalls, counterfeits and product diversions, it seems crazy that no organization (either government or industry) has stepped up with a solution.
For a long time, it looked as though the California E-Pedigree law would be the only legislation requiring unique labeling and traceability of pharmaceutical products, especially since the federal version seemed to be going nowhere fast.
Finally however, Mr. Obama has signed into law HR 3204, The Drug Quality and Security Act.
The Act actually has two parts, one of which is concerned with managing the compounding of human drugs (problems in this area were highlighted by the recent meningitis outbreak which was traced to a compounding pharmacy in Massachusetts). This section is the Compounding Quality Act.
The second part of the Act, the Drug Supply Chain Security Act, is intended to introduce a unit level traceability system based on serialization for pharmaceutical products.
You can read more details on the Act on the Congress.gov site.
One important result of the Federal Act being passed is that the California rule will not be brought to fruition – or similar rules that have been proposed by some of the other States. There is no question though that the work already done by the California Board of Pharmacy has had a huge influence on the passing of HR 3204.
In order to uniquely identify individual pharmaceutical product packages, it is going to be necessary to have national standards (ideally International standards) to ensure that there is compatibility between the labeling of all the different manufacturers and distributors as well as a means to be able to apply serialized data to different types of pharmaceutical packaging.
Having recently issued the UDI identification rules for unique labeling of medical device products, it isn’t a huge stretch to see the pharmaceutical rules being somewhat similar. I’m sure that GS1 and the GTIN (Global Trade Item Number) system will be a big part of pharmaceutical serialization.
Because the printed serialization data will need to be machine readable, it is a safe bet that the Datamatrix barcode format will be used.
With the government being involved, it is safe to assume that it will be some time until the new Act is fully implemented. It is likely that the new labeling rules will be phased in over a period of several rules.
Adding Serialization Data to Packaging
While there is sometime before compliance will be essential, this is a good time to start to put in place the systems needed to be able to add the variable data to labels and packaging.
As each layer of packaging is built, the traceability information needs to be printed to each new layer.
The marking on each level will be such that scanning the barcode will give access to the information for everything contained on that level.
Here at ID Technology, we have great solutions for all the layers of packaging needed in the pharmaceutical industry.
Variable Data for Labels and Packaging
Our LSI labeling systems are perfect for handling pharmaceutical labeling applications. With many years experience of meeting the specific needs of the industry for labeling, coding, inspection and validation, LSI is a natural choice. In addition we have excellent relationships with the Manufacturing Execution Software (MES) providers to allow for trouble free integration into your systems.
See out complete line of serialization enabled labeling systems, here.
Many labeling systems currently in use in the industry use simple hot stamp coders to apply date and lot codes to labels before application to the container. ID Technology offers two digital coding solutions that can replace hot stamp printers and allow for the coding of individual text and barcodes to pharmaceutical labels.
Thermal Transfer Overprinter (TTO)
Our Compact 32d Thermal Transfer Overprinter has been specifically designed to be a simple drop in replacement for hot stamp printers.
Being about the size, the existing brackets can often be used, with some minor alterations (if needed). The Compact 32d uses a 300 dpi printhead and can give really good results while printing text and both linear and 2D barcodes.
The TTO printer is also ideal for printing variable data onto flexible packaging on flow-wrappers and form-fill-seal machines so can be very helpful for other layers of packaging too.
More info on our range of Thermal Transfer Overprinters can be found over at the ID Technology site.
ID Technology’s laser coders are also idea for pharmaceutical serialization applications. Lasers can be used to mark text, logos and barcodes onto labels, cartons and other types of packaging.
IDT lasers are compact in form factor making them simple to interface with most labelers or other packaging equipment. They are also fast, quiet and use no consumables, keeping the cost per marked product as low as possible.
For laser marking on pharmaceutical packaging, a layer of print is usually removed by the laser to show the underlying contrasting material below.
This can produce excellent print quality, while printing the unique text and barcodes needed for traceability.
IDT has a range of laser equipment, CO2, YAG and Fiber in a variety of power ratings, for just about every laser coding or marking application.
Labeling Aggregated Bundles
If your packaging process involves aggregating products into wrapped bundles, the LSI 1220 labeling system is specifically designed to capture the unique IDs of all the items in the bundle, assign them to that particular package and print/apply compliant labels for that level of packaging.
Labeling Cases and Pallets
For the “end of line” labeling applications, ID Technology/LSI labeling solutions are unsurpassed. Our Model 252 Label Printer Applicator is the latest evolution of the best selling product in this class and it has a wide range of applicator modules for just about any labeling job.
For cases and pallets, just a single label or multiple – there is a 252 solution available.
I’m a label guy so it’s hard for me to say this, but there are other technologies that can be used to mark cases for pharmaceutical serialization – see my post from a view weeks ago that discusses laser marking and hi resolution inkjet as alternatives to labeling for shipper cases. One of the great things with ID Technology is that we can provide all the technologies so we can be completely objective when helping our clients.
How to get started
A lot of pharmaceutical companies have already started to enable serialization in their operations – largely to meet the California plan. For anyone not already getting a plan together, an important thing will be to ensure that any packaging equipment you buy that will need on-line coding, has the capability to produce the on-demand 2D barcodes that will be needed. We obviously strongly recommend LSI labeling systems for all your pharma prime labeling needs.
It is also a good time to take an inventory of the capabilities of your existing coding and marking equipment and see what needs to be updated to handle the variable data printing that will be required.
If you want to talk pharmaceutical labeling and serialization, feel free to contact me at 603-845-9375. You can also contact our main office at firstname.lastname@example.org and we’ll put you in touch with an ID Technology specialist in your local area.
If you are in the pharmaceutical industry, what steps has your company taken to implement serialization? Is there anything I’ve missed that needs to be taken into account? I’d love to hear from you.