- Can you give us an overview of the Dividella machines and their capabilities?
The Dividella NeoTOPx is an automated secondary packaging system with the flexibility to carton various injectable drug presentation formats including vials, syringes, pens/auto-injectors, and multi-component kits. The system uses 100% monomaterial (cardboard) in its packaging solutions and cartons can be customized to various sizes and shapes. The semi and fully automated packaging processes include carton erecting, partition forming, product and component loading, through to carton closing, printing and verification.
The system allows for quick format changeover with reduced downtime between batches increasing efficiency and production flexibility. With fast turnover between batches, it is ideally suited for packaging small lot sizes of less than 2,500 units, enabling rapid launch support without compromise on quality or safety. In addition to running small batches, the Dividella has the agility to scale up to run large biotech product batches of 5,000 units per lot and more.
2. What motivated Sharp to invest in the machines? How do you plan to leverage their capabilities to improve your offering?
As drugs become more specialized, trending towards personalized injectable medicine, lot sizes will continue to decrease. Additionally, the package profile of these specialized products often requires various ancillary components to be packaged along with the drug product. These ancillary items include components such as needles, leaflets, infusion tubing/support components, patient education items, and other items that support the overall infusion of the product. This shift toward smaller batches combined with multi-component kitting means that flexibility and automation of the packaging process are more important than ever.
Dividella’s scalable solutions expand Sharp’s strategic packaging support for our clients throughout the commercial life cycle of their drug product from clinical through commercial production. Sharp’s investment in the Dividella system will allow us to continue to support the growing needs of our existing clients and their high-volume high-cost specialty medications. It will also allow us to meet the packaging needs of virtual biotech clients and the rapid launch of their treatments for rare and orphan diseases produced in smaller batches.
3. Will the machines be integrated onto existing lines? Will there be any process changes? What will the impact be?
The Dividella’s have been set up as additional capacity in both our US and EU sites with integrated serialization functionality. Additional capabilities are available in the downstream process including market-specific labeling as well as shipper and pallet aggregation. We’ve chosen this configuration to maintain the highest flexibility which enables us to support just about any requirement from our clients.
4. What value do the machines offer Sharp clients?
The Dividella is a significant investment with lengthy implementation and qualification timing. Sharp extends the benefits of this technology and the specialist technicians who support this technology to our clients. For clients launching orphan and rare disease treatments with small-batch launch volumes, partnering with Sharp helps eliminate the roadblocks to a rapid launch.
Clients with multiple products in their pipeline can standardize on a common package design format across their entire product portfolio which has become a common cartoning requirement for many major pharmaceutical companies. This standardization helps simplify purchasing management and increases packaging production flexibility.
The Dividella cartoner also has automation and inline inspection features which, when coupled with a top-loading function, offers excellent visibility to each component as it is packaged. This minimizes any potential for errors and improves overall Quality compliance and control.
5. Are there any efficiency benefits? Can you quantify them?
The design of the Dividella system supports quick format changes. With the trend of SKU run sizes decreasing, our focus is to keep the line downtime between SKU changeover to a minimum so we can increase production flexibility. Flexibility is further increased when maintaining the same carton dimensions across different products and only changing the internal partition.
6. Are there any particular product types or market segments that the machines are naturally tailored to? Why? How will it improve Sharp’s offering in these areas?
The Dividella is a perfect fit for high-value injectable biotech drug products manufactured by both virtual/small biotech companies and large pharmaceutical companies. By having the Dividella systems qualified and ready to support production, Sharp eliminates the risks our clients would face onboarding new technology and training specialist personnel.
Sharp’s investment in high-end technology solutions like the Dividella proves our commitment to remain a leading contract pharmaceutical packaging partner focused on supporting our client’s evolving needs.
7. Are there any other benefits such as improved sustainability?
In an effort to reduce the impact on our environment, the pharmaceutical industry is moving toward carton designs that are not only patient-friendly but also made of sustainable materials with compact external dimensions. The Dividella uses 100% monomaterials (recyclable cardboard) solutions which eliminate the use of plastic trays and blisters. In addition to sustainable materials, the pack sizes are optimized for volume further reducing environmental impact when considering transportation.
8. Does the machine support serialization compliance? How?
Yes, we offer serialization with aggregation at three levels for injectables – carton, shipper, and pallet. With Sharp’s 10+ years of serialization experience and our long-standing partnership with Systech, we deliberately chose to integrate technology with the Dividella. On the carton level, we serialize using our current Sharp standard process flow. For shipper and pallet aggregation, we selected an in-line Systech technology that will sit on the hardware platform of another OEM allowing maximum production flexibility.
Through serialization, we ensure our clients maintain authentication of their drug product as it moves through the supply chain as well as help reduce counterfeiting to protect prescribers and patients.
9. What impact does the machines’ automation have?
This impact is big. Automation will help reduce the cost of goods and ensure consistently high quality.
The Dividella configuration we’ve chosen can support our clients with complex packaging requirements. It includes fully automated carton erecting with partition, which would not be feasible as a manual process. Additionally, the automated process includes kitting of leaflet(s) bundle loading, version control, camera verifications and more. Still within our configuration, there is also the option to manually load components in the kit which gives us the flexibility to handle a wide variety of components.
10. Is there a potential impact on patients?
Patients will receive products that are securely protected in user-friendly packaging that have been fully inline verified assuring accurate verification of product and components packaged. The cartons are inherently designed to ensure clear product overview and can be easily re-closed. Our clients may opt for additional carton design features that are beneficial to patients including easily accessible leaflets and patient guidance to assist with patient compliance.
11. What are the benefits of late-stage customization?
From an operational standpoint, this means small run sizes and quick changeovers which is in the DNA of the design of this production line. With the Dividella configuration we’ve chosen, the high complexity and high component count kits are supported.
Partner with Sharp
When you partner with Sharp, part of UDG Healthcare, you leverage a very powerful global network of facilities, expertise and experience of skilled packaging professionals. We collaborate closely internally and with our clients to innovate and create inherently flexible packaging services to meet the growing demand for small-batch manufacturing.
About the authors:
Site Manager, Hamont-Achel, Belgium
Guido leads Sharp’s Belgium packaging facility and is responsible for the site’s overall performance and P&L, as well as the sites transition to Sharp EU’s Injectable Center of Excellence. Guido joined Sharp in 2008 holding various positions including project engineering and leading the EU project management organisation.
Victor J. Virginio
Director of Engineering
Global Innovation and Technology Services
Allentown, PA, US
Vic leads the Sharp Corporate Engineering group for Global Commercial Packaging and is responsible for all technical aspects of packaging at Sharp throughout the project life cycle (i.e. project management, packaging equipment engineering, packaging validation, tech transfer and production support). Vic supports all Sharp facilities to pioneer the sharing of new product innovations and technical concepts with our clients.