John Kawochka spent 31 years as a manager for special projects with Pfizer Global Manufacturing Services. Now hes senior VP and chief technology officer with EAM Corp. (Long Island City, N.Y.), plying uncharted waters in anti-counterfeiting and drug security, from laser drilling of tablets to barcoding with edible inks. Several major manufacturers are working with EAM to test and develop its tablet-level printing and drilling technologies.PharmaManufacturing.com spoke with Kawochka to find out more:PM: You're barcoding tablets for what reason? JK: The counterfeiting of pharmaceutical products is rampant around the world today. While the dollars lost are staggering, the risk to the patient is most alarming. We at EAM felt it was now time to develop a new system design which can interrupt the counterfeiters and provide a unique way to mark individual tablets. We have now accomplished that goal. RFID seems to be lagging, not living up to all the hype it had a few years ago. Some companies are attempting to adapt but not to the extent it was promised. The expense is very high and it would be very difficult to place an RFID tag on a tablet. Yes, the labels are marked and so are the cases. Labels and cases can be tracked, but what happens to the tablets? Isnt the finished product that the patient ingests the most important part to track? We have developed a system which can dynamically link each stage of the packaging process to the next and then be traceable to the pharmacies and hospitals, where it is dispensed to the patient. By providing a unique bar code marking on a tablet, caplet or capsule, manufacturers can trace and track all products from the manufacturing stage where tablets are produced to the packaging line all the way to pharmacies and hospitals, protecting the integrity of the supply chain from the print stage to the point of patient dispensement.PM: How is the bar code actually printed on the tablet?JK: We can apply unique bar code and data matrix identifiers which can sequentially mark every tablet. This is done with a patented tablet handler which holds each individual tablet in place at the print stage. This is required to ensure proper placement of the bar code. Without the secure patent-pending firm grip design, the bar codes or data matrix cannot be read by todays scanners. The tablet is individually held in place and then printed with the marking at very close proximity and at high speeds. The tablet handler has a trace and track system of its own, knowing exactly where each and every tablet is in each lane. Before going to the good product bin, it is verified that it has the correct data or it is automatically rejected.Individual markings such as bar codes or data matrix duplicating the tablet markings can then be placed onto the bottle labels, blister cards, individual cartons, tracking the presence of each bottle or blister card and IFC before it is printed. PM: All this seems pretty difficult to do. JK: Yes it is, but nothing is impossible with todays technologies. You do need the right people and the right talents to create something unique. We have accomplished just that. In my time at Pfizer, I visited many Pfizer sites, as well as those of competitors and partners around the world. All the sites I visited have similar and in some cases identical equipment. Only the product is different. Providing the right tools, training and awareness is crucial to be successful in any project. Identifying your needs to be successful is step one, step two is to do it the right way. We have that right way for anti-counterfeiting. PM: How about the cost?JK: It depends on what the individual site requirements are and how detailed a system they want implemented. The proposed system will include for manufacturing a tablet handler or printer which will apply the individual markings on each and every tablet. Optional vision systems are available to 100% inspect tablets to ensure the markings are correct and readable. These vision systems are mounted to the tablet handlers.It then goes to packaging, where a printing device can apply individual markings on the bottle label, blister card, IFC, and cases. Each and every stage can be validated via scanners to ensure proper placement and correct data. Once it leaves the plant and goes to the pharmacy or hospital, a unique trace and track system is initiated.PM: What response are you getting from drug manufacturers?JK: Right now, there is high interest in our pharma anti-counterfeiting design and system approach. We continue to receive favorable reports on our systems in the field, and we will continue to focus on new technologies for pharmaceutical production and packaging.For more information on EAM Corp., visit www.eamcorp.com.
