The Drug Quality and Security Act (DQSA) was signed into law by President Obama in November 27, 2013. Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA), outlines critical steps to build an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the United States . Under this law, by November 27, 2017, pharmaceutical manufacturers are required to print a unique identification code on all prescription units of sale distributed in the United States.
In order to comply with this deadline, companies must ensure that their packaging operations are serialization ready. In other words, the packaging lines must be provided with the appropriate printing, verification and rejection stations for the required unit or item serialization level. When referring to unit or item serialization level, it is important to understand what your unit of sale is. According to the DSCSA, an “individual saleable unit” is the smallest container of product introduced into commerce by the manufacturer or re-packager that is intended by the manufacturer or re-packager for individual sale to a dispenser . That individual saleable unit could be a carton, bottle, bundle or a shipper. So the packaging processes in question must be prepared to print a unique identification code to each individual saleable unit.
Serializing an existing packaging processes or a new one is a complex task. It includes many critical activities like programming the serialization software, installing and physically integrating the required equipment in the packaging line, synchronizing the communication between equipments, storing the data and validating the new serialized process. This is without counting the after-implementation tasks which includes training efforts and line efficiency adjustments to account for the learning curve typically observed in new operational processes.
Using multiple suppliers for the different phases of a serialization project, can make the project even more complex. The use of multiple suppliers bring more variables into the game, which translate into potential communication difficulties, potential delays in transferring project phases, lack of coherence between project phases, lack of accountability which in the end means increased project risk management efforts.
Considering a turnkey solution for this type of project is an option. In a turnkey project, the contractor or provider undertakes the entire responsibility from design through completion and commissioning. The client or customer only has to turn the proverbial key to make everything function as it should . The benefits of this type of solution include a reduction in total project execution time, a significant cost reduction, improved communication and a noteworthy risk reduction.
Ultimate Solutions Corp. (USC) has come up with a serialization solution called the VIS+ model. With this model, we offer our clients a turnkey solution that covers the serialization process from the beginning to the end. VIS+ stands for V = Validation, I = Integration, S = Serialization and + = FITS (Facilities for Integration and Testing) at Ultimate Solutions that provides the space to complete the integration project phase.
As a packaging solutions provider, our team counts with knowledgeable and experienced resources in validation, automation, line integration, vision systems, serialization, among other technical fields. Our regulatory knowledge moved us to work closely with Systech Only One as a Partner to better understand and work with the Serialization and UDI requirements of the Drug Supply Chain and Security Act (DSCSA).
As part of our Technology Department, in our Serialization team, we have certified Project Managers (PM’s), Project Engineers (PE’s), Field Engineers (FE’s) and recently a certified trainer whom have participated in different projects globally. We also count with programmers and integrators with serialization expertise. In addition, we have Validation Engineers with extensive experience and knowledge in Serialization Projects.
Our VIS+ model has proven results in mitigating the typical risks of a serialization project; improving communication, lowering project delivery time and minimizing costs. The Case Study below provides specific VIS+ model performance data gathered during project initiation, planning, execution, control and closing.
In this project, the hardware and the software to perform the carton and case label serialization and its respective inspections stations were installed in one of our customer’s packaging line. In this particular project, the serialization process begins with a carton print and verification station, followed by a case label re-winder station and end-of-line equipment. The following paragraphs provide a brief description of the process flow at each station.
Carton Print and Verify Station:
The process flow begins with unprinted cartons arriving at the printing station. Batch variable information and/or a unique serialized code are printed on the primary face of the carton. Downstream of the carton printer, a vision inspection is performed on the carton face. The carton inspection verifies the batch variable information and serialized code on the carton. If all of the vision inspections pass, the carton serial number is commissioned and continues downstream the packaging line. If any of the vision inspections fail, the carton is flagged as a reject item and the serial number is decommissioned in the line server database.
Case Label Re-winder Station:
A case label is printed at the Label Reel with a serialization capable printer. Upon the receipt of a print signal derived from the label printer control system, the line information management software (line server) is programmed to download the appropriate serialized code and batch variable information to the case label printer.
A vision inspection is performed on the case label re-winder with human readable text as well as the serialized barcodes for validity. In the event the camera station failed, the associated 2D label serialization number is not commissioned in the line information management software database, the case label is flagged as a reject and the system stopped. If a reject is flagged for any reason, the operator is alerted to manually remove the bad label. If the inspection passes, the case label is ready to be manually applied to the case.
Commissioned cartons proceed downstream on the conveyor to the spacing wheel. Immediately following a spacing wheel, a vision inspection is performed on each carton. The vision inspection verifies the serialized code on the carton to ensure the carton is commissioned and can be aggregated to a case. If the inspection passes, the carton proceeds to the manual pack station and the end of the conveyor. If the inspection fails the carton is flagged as an eject item and is automatically ejected from the line.
After the case has been packed with the correct number of cartons, the operator manually applies the printed case label on the case. A handheld barcode scanner is used by the operator to scan the serialized code on the case label.
If the scan passes, the PLC turns a stack light, indicating a good case label had been processed. If the scan fails, the PLC drives a stack light to indicate a failed case label. Failed cases are manually removed. The PLC starts the packing process by letting cartons pass through the spacing wheel. It will count the number of incoming cartons to keep track of the number of cartons allowed in. The PLC will only allow the exact number of cartons to pass the case infeed inspection station PLC.
Like other complex projects there are many challenges to face during project planning and implementation. According to Edna Rodriguez, Ultimate Solutions Validation Specialist at the time, the biggest challenge faced during the Validation was to meet the customer’s project timeline, which was very aggressive. From the Integration standpoint, Rene Montanez, Automation Specialist, indicated that the mechanical design process was a big challenge for the team. He said that being able to emulate, at Ultimate Solution facilities, the electrical panels with correct distances to the packaging line was a challenge overcome thanks to the team’s expertise and good communication with the customer. Carlos Castro, Project Engineer at the time, mentioned that Serialization phase’s biggest challenge was the implementation of a customized solution, as opposed to a standard one, requested by the customer. Ismael Aviles, project manager, recalls the control in scope changes and the costs associated with these changes to both customer and supplier; as the biggest challenge in managing the project.
The benefits of using this approach are many, according to the all project key players. Ultimate’s participation in equipment Factory Acceptance Test (FATs) and standardization between phases facilitated the validation processes. The “communication barrier” between suppliers is eliminated and the concern about sharing sensitive or confidential information does not exist. The communication between key players and among phases was very good. Information was available faster than when compared with scenarios in which multiple suppliers are involved. There was a single point of contact. The accountability of each phase owner was very clear. Erick Fuentes, Field Engineer, said: “We all knew what was happening at all times”.
Another benefit of this solution is the fact that the integration space was provided. This gave the team control of the project and its timeline. Our team had access to the equipment and was able to work as needed; as opposed to projects in which integration and validation activities are scheduled according to the plant’s manufacturing plan and have to be escorted by plant personnel. All these factors accelerated the design, execution and completion processes.
According to Ruben Morales, Serialization Project Manager at the time, the biggest benefit of having a single supplier for this type of project is the ability to manage better the project schedule. In a typical serialization project it is common to have multiple suppliers (OEM, Serialization, Integration, Validation, etc) so if each supplier follows and protects their own phase plan a delay in total project completion is expected. On the contrary, when having a single supplier, there is only on project schedule to follow.
Phase transitions were “smooth and transparent” indicated Ismael Aviles. Having all key players centralized in one project is a significant advantage. We had the opportunity to have real time status of what was going on at all times. For that reason, we could mitigate project risks by reacting faster without affecting project timeline. A good communication plan was also a success factor.
We established our communication plan since the beginning of the project. We had verbal and written communication. We provided written weekly status. We had weekly conference calls. The communication platform used in this project provided the opportunity of having daily communication, when needed, between customers and the USC team. Additionally, we gave our customers the flexibility of visiting our facilities as many times as needed so they had access to critical project information.
“In my project management experience I can say that the overall project efficiency was better than scenarios in which multiple suppliers were involved. We completed more work in less time. We maximized resource utilization by having resources that can contribute to more than one phase. When working with different suppliers typically each one brings their point of view and ends up causing communication delays and therefore in project completion time.”
The VIS + model provided us with the opportunity to design, execute and control our work plan. For that reason, we were able to complete within the time, cost and resources utilization expectations.
When compared with other projects in which we executed only one or two phases of a serialization project, the VIS + model allowed us to deliver the entire project in less time (4 months), using fewer resources, with a 20% cost reduction, and a significantly improved quality and reduced risk.
In conclusion, Ultimate Solutions Corp. can offer a solution according to your packaging serialization needs. Our VIS+ model is a viable option for a rapid serialization implementation that you can consider to meet the November 2017 deadline.
- https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ DrugSupplyChainSecurityAct/_
- Document 8958-PIM-110-000-D&I-SPEC (PACKAGING INTEGRATION MODULE 10-000- DESIGN& NTERFACE SPECIFICATION-CARTON PRINT & VERIFY) 5. Document 8958-MHP-D&I-SPEC (DESIGN& INTERFACE SPECIFICATION- MANUAL – HAND PACK STATION WITH SPACING WHEEL)
- Electrical panel & integration simulations at our facilities
- Implementation of customized solution, as opposed to a standard one
- Validation and overall project aggressive timeline
- Project scope changes and associated costs
- Ultimate’s participation in early stages of the process facilitated the validation process.
- The communication “barrier” between suppliers and key players is significantly minimized.
- This model gave us control of the project schedule and timeline since we were integrating at our facilities and had all key players as part of our team.
- Better project efficiency.
- Smooth phase transitions & less cost.
Author: Rosamari Feliu, VP Business Development