By Carla Reed, president, New Creed LLC
Once a small or large molecule product has passed the various hurdles in clinical trials, it faces important considerations related to market acceptance and commercialization. Irrespective of the nature or formulation of the product, there is always a heavy focus on the primary packaging element — the final unit of use. In most large companies (and probably many smaller ones) there is a team of experts engaged in designing packaging, taking into account geographic preferences, regulatory requirements, and patient profiles.
A great amount of time and money is spent on evaluating dispensing units for sprays and inhalants, blister-packs versus bottles for individual dosage of tablets and gel-caps; the list is extensive. Then there is the literature, labeling, and even the folding of package inserts (and their location within the package), all of which must be reviewed by teams of experts. Considerations include the protection of the product, ease of use at the time the product is consumed, ergonomics, and other issues for nurses, patients, and other parties. These are critical issues that a whole industry is involved in evaluating and perfecting.
As a supply chain person, I am always thinking about things like packaging from a different perspective. Considerations that are important to me — and should be to others in the business of moving things around the world — are how well the packaging component fulfills its function of product protection in variable situations.
A recent conversation with a colleague, in which he compared the package experience to that of a passenger experience on a transportation device, put my mind on an interesting train of thought. Unlike a passenger who has the ability to respond to changes in the environmental conditions during a journey, the inert package is pretty much at the mercy of the resources engaged in transporting it from origin to destination. Unable to express displeasure or alarm at unexpected events, packages are left in harmful conditions – at receiving and shipping docks, on airport tarmacs — or even worse, left behind.
The solution — providing packages with the ability to respond to unplanned events and conditions, raising the alert as needed — is a viable reality.
There are many options available for improving the package experience by using protective packaging, including active and passive temperature monitoring and control, as well as sensors that communicate in near real time. The ongoing location and state of the material, as well as its point in the chain of custody, can be monitored through an increasing number of wired and wireless information systems and alerting technologies.
Secondary packaging, at times an overlooked element of product life cycle management, should provide protection for the material or product across all the process steps, from final packaging at production through consumption, return, and disposal. Understanding the process flow, activities, participants, and risk factors across an increasingly extended chain of custody is the first step. Environmental conditions, with risks of variations in temperature, humidity, and altitude, tend to get the most attention. Other factors include light sensitivity, orientation, air pressure, shock, and vibration — any of which can have a negative impact on fragile biological materials, even when they are cryopreserved.