By Angela Shotton, business development manager, Nelipak Healthcare Packaging
Developing and bringing a medical or drug-delivery device to maturity is a complex process that often involves passing clinical trials, ensuring reimbursement, and figuring out the manufacturing process. As if that wasn’t time consuming and challenging enough, device manufacturers still need to worry about selecting the right packaging to ensure those devices are then protected and remain correctly positioned, which depends heavily on choosing the right packaging partner.
Over the last few years, there has been significant growth in the automation of injection-molded delivery devices for the pharmaceutical and medical markets. Yet, for popular devices such as inhalers or auto-injectors, standard trays are not a strong option because these particular devices require a special tray made to hold that specific device. As a result, there is greater risk involved if the tray is not properly designed because of a lack of understanding of the specific processes and interface with the equipment involved. Therefore, it is a crucial task to choose the right handling tray that fits the device as well as the automation, transportation, and user requirements involved in the overall process.
However, selecting the handling tray that meets all the requirements for a particular medical device and the automation process is no easy task. The manufacturer, automation provider, and packaging company often need to compromise to find the ideal solution. The wrong choice can mean that empty trays do not separate properly in the automation process -- requiring manual intervention, which results in extra costs caused by downtime and reduced run rates. Too much tolerance from tray to tray may lead to product misalignment, causing potential product damage and disruption on the machine. Poor packaging density can reduce the autonomy of the machines, increasing both manual loading requirements and increased transportation costs between the contract manufacturer and the filler.
For medical device and pharma companies, it is therefore essential to meet with the injection molder, the automation provider, the packaging supplier, and if involved, the contract manufacturer to specify the needs for both the process and the device before it is decided how the trays should be designed. At the beginning of each new project, all parties should hold a kick-off meeting to clarify aspects that are critical for the packaging, such as device orientation in the tray; determine critical areas of the device, which require extra protection; and determine how the device will be handled. If, for example, the device will be picked up by grippers, the next questions would be where and how much gripper access is required. This can result in a feature being built into the tray to accommodate this.
As these projects involve multiple parties with often-conflicting requirements, understanding these requirements and helping to propose an acceptable solution to all is key. Skilled packaging design teams should approach projects in a way that ensures that all input is captured and correct advice is given. For example, consider a project where one of the parties asks for the device to be placed upright in the tray, as this might be considered easier for filling. However, another party wants the device laid flat because it is better for transportation. In this case, a good approach for the packaging supplier may be to come up with proposals for both tray designs, accompanied by a packaging density study. This would allow the parties to carry out a cost-benefit analysis and reach an informed decision based on the results.
Additionally, at the onset of a project, the initial wants of the customer may not ultimately result in the ideal result. For example, a request may be made for three differently sized trays for diverse variants. However, if this scenario were to be carried out, that customer could be faced with increased equipment costs and required to make a manual intervention at the end of the batch in order to begin making a different variant. This is owing to the fact that the original request would require the adjustment of guides for each of the conveyors to ensure that the machine operations are optimized for each tray.
Achieving optimized packaging tray design and automation processes requires a willingness to take all feedback into account. Improvements are achieved very quickly when each stakeholder works with the team and accepts that compromises will be required to achieve the best overall result.
For more details, be sure to visit Nelipak at Booth #1969 at MD&M West in Anaheim, CA, February 9-11 and at Booth #219 at Pharmapack Europe in Paris February 10-11.