Simon Whitnell, a designer in our Global Design Center in Allentown, discusses the increase in the demand for kit designs and a trend towards the customization of lot, expiration and serial number code areas.
Due to the rise in the number of the smaller virtual pharma companies in the market, as well as larger pharma companies looking for a one-stop-shop, we have seen an increase in the demand for the design and prototyping of multi-component kits. Instead of simply the drug product and a Pi going into an RTC, our clients are asking us to bundle and combine everything into one package.
Some of the items that we have recently “kitted” include: syringes, needles, IFU’s, Pi’s, devices, batteries, power cords, reorder cards, coupons, alcohol swabs, vial adaptors, inhalers, thermored trays, band-aids, interactive reminder calendars, “return cartons”, and sometimes a combination of vials, blisters, and bottles.
Evolving customer requirements: Customized Lot/Expiration and SN code areas
Stringent regulation, counterfeiting and diversion have put pharmaceutical companies under increasing pressure to implement trusted track-and-trace techniques across their products. The knock-on effect of this regulation means more data needs to be accommodated on the printed package. As a result, we have noticed an increase in the number of our clients that want to customize the code areas’ look and layout.
Although we have standards that we use as a starting point and a placeholder, these layouts don’t always completely fulfil our client’s expectations. As our clients go through this regulatory learning curve, we collaborate with them to balance their demands with what is possible and practical, in terms of printing and reading on our production lines.
Serialization from the Sharp perspective
Our long experience and deep expertise in implementing serialization solutions for our client has meant we can aggregate serial numbers for up to five levels of packaging in multiple formats, from the individual cavities of our blister packaging right through to their shippers and pallets.
For our client’s, it means the peace of mind knowing their drug product is using industry-leading traceability technology, providing extra protection for prescribers and end users.
The demand for serialization had resulted in greater complexity in package and carton solutions and a higher level of coordination of components but it has also resulted in richer client collaborations, where we are challenged to innovate and create a solution that satisfies both regulations and our pharma clients.