By partnering with its printing equipment and software supplier, this pharmaceutical manufacturer is on track to apply serial numbers to meet the 2017 DSCSA deadline.
By Jim Butschli
During the last quarter of this year, pharmaceutical manufacturer Cetylite Industries Inc. [9] plans to test the application process of serialized numbers on its packaged drug products, with the intention of applying serial numbers in the first quarter of 2017 to meet November’s deadline for DSCSA (Drug Supply Chain Security Act) regulatory requirements.
A key to meeting DSCSA deadlines for this third-generation, family-owned Pennsauken, NJ, firm is its partnership with Nutec Systems, Inc. [10]
“Nutec equipment provides software, product-specific programming, and printing solutions for our product labels, individual folding cartons (IFCs) and case labels,” explains Bruce Epley, Cetylite’s Director of Operations.
After obtaining proposed serialization solutions and quotes from three other suppliers, Cetylite selected Nutec and commenced installation late last year.
“Nutec provided a flexible solution that best matched our packaging practices at a very reasonable price in comparison to the competitors,” says Epley. “Nutec was very informative and did not try to ‘upsell’ or provide equipment or solutions that were not required.”
Equipment portability adds flexibility
Cetylite packages exclusively out of its 28,000 sq-ft facility, which includes production, warehouse space and offices. The company produces about 20 products in all, both drug and non-drug varieties. Its product line includes prescription topical anesthetics, infection control products, and other complimentary dental products. In all, 18 of the products are liquids, one is an aerosol and one is a gel.
A majority of Cetylite’s products are labeled bottles packed inside of a carton, which get filled into a case. The company also packages kits that contain a labeled bottle, tips and syringes, as well as one offering that includes two products within a single carton.
Epley notes, “We operate in a flexible environment with one packaging room. Depending on the product, we will move the needed (portable) equipment in and out of the packaging room based on the packaging configurations.
“We have four filling machines with two in fixed locations and two different types of labelers with one in a fixed location. This equipment will be configured to support and feed the packaging line but we run one packaging configuration at a time. We configure the line to meet the packaging needs of the product.”
According to Epley, a key challenge for Cetylite “was to find a flexible solution to implement into our manufacturing process that would allow us to meet the current and future regulatory requirements of the DSCSA. With just one packaging room handling all of our packaging configurations, finding the coding and vision equipment solution at a reasonable cost was a time-consuming process. We could not afford nor did we have the space to implement multiple standalone solutions.”
‘BlackBox’ solution
To address those needs, Cetylite installed print and vision systems on two of its labelers. “Nutec designed and built the print station for coding all of our cartons, which includes a vision system and reject station,” says Epley.
All of this is controlled through Nutec’s BlackBox print/vision inspection/line control system for labels, cartons and cases. Its functions include the following:
- 2D barcode printing, inspection, and line stop control of two existing labelers. One of these machines, an Accraply[11] labeler is configured with four printheads, one encoder, one print trigger, and one 2D code scanner. The other labeler, from Harland[12], is configured with one printhead, one encoder, one print trigger, and one 2D code scanner.
By reconfiguring printhead cable(s), encoder cable, trigger cable, and 2D code scanner cable, the BlackBox System can print and inspect on either labeler with the same controller. Special operator interface software allows the appropriate configuration to be selected for either labeler.
- Print, inspect and reject of IFCs on a Nutec print-and-inspect conveyor system equipped with motorized top hold-down belt. The system includes a motorized conveyor assembly with synchronized top hold-down belt for product carton control through the print-and-inspect stations.
An optical character verification vision camera with integral lighting inspects both the printed 2D code as well as human-readable text. A vision inspection “PASS” allows the carton to continue through the system while a “FAIL” results in the carton being rejected from the line.
- The Nutec case label print and manual 2D code inspect system is supplied with a stainless-steel work table on which a Zebra [13]GK420d printer and handheld 2D code scanner are mounted. Both the printer and scanner are connected to the BlackBox control, and all interconnects/drivers are integrated into the system.
The printer function provides entry, transfer, and printing of GTIN, lot code, and expiration date information via the touchscreen operator interface. The 2D Code and text “matchcodes” are automatically transferred to the scanners/camera as part of the data entry/transfer process. The line stop/reject functions are performed by the system PLC, and all process status and alarming is provided at the Operator control unit.
Ready for serialization
The BlackBox System, as installed, is serialization ready and track-and-trace-capable. The system generates print-serialized data for use in GS1 codes, and can perform track-and-trace functions (aggregation) by purchasing and installing the Nutec track-and-trace software module option.
For Cetylite, the BlackBox concept is “plug-and-play” in that the company can utilize Nutec components as needed based on the equipment required to support the specific packaging operation.
Epley explains, “Through multiple discussions and the understanding of our process, Nutec was able to design just one BlackBox control system for all printing and vision inspection functions associated with all of our packaging configurations. With Cetylite only packaging one product at a time, multiple standalone systems were not required. This was a significant cost savings benefit.”
Of course, serialization is a critical issue for the company—“part of meeting the future regulatory requirements,” says Epley. He says finding and clearing the required space on labels and cartons to apply the 2D codes and human-readable information is a major aspect of the serialization process.
Cetylite has the equipment in place to apply serial numbers and 2D codes to its drug products. However, he notes, “We have not yet tested or validated the serialization part of the process. Cetylite is currently applying 2D codes and human-readable information for the GTIN, lot, and expiration date for over 90 percent of our drug and non-drug products. We’ve taken the approach of ‘let’s walk before we run.’”
Does the company have specific plans to make all of its packaging lines/equipment “serialization-ready?” Yes, he says, adding, “With the Nutec equipment already being selected and installed, our next steps are to test the application process of the serial numbers. We will apply serial numbers to our drug products but we have no intention of aggregating products or communicating data downstream at this time.”
In the future, he acknowledges, “Aggregation and capturing of the data will need to be addressed.” He believes additional Nutec machinery will be helpful for Cetylite to meet aggregation regulatory deadlines.
Epley notes the DSCSA, serialization and aggregation issues all present challenges for Nutec and the Cetylite packaging lines. Among them: the effect of electrical interferences on print quality and getting the proper ink for the coding of the labels and cartons to ensure quality reproducible codes.
In terms of economic return-on-investment to meet DSCSA and serialization regulations, Epley’s response is not uncommon: “As for the justification of the investment, Cetylite has struggled with this considerably. We see no significant benefit to the business or return on our investment.”
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