User Scenario - Pharmaceutical & Life Science
Anne-Marie is a Quality Manager for a European vaccine supplier. She has been concerned for some time at the growing regulatory pressures, and aware that her company only provides temperature monitoring of products it despatches when the customer demands (and is prepared to pay for this).
Vaccines, biological pharmaceuticals and reagents are highly temperature-sensitive (typically needing the be maintained at +2 to +8°C) and with rigid specifications on what excursion ‘window’ (temperature x time) is allowed. The implications in terms of effectiveness and potential penalties are severe.
Gaining approval across its range of products for the various standards (CFR11, FDA, EU GDP and GAMP Regulations) would be time-consuming, but in any case would require evidence-based certification on how the product had been treated once it had left the company’s refrigerated cold storage.
Colleagues have been involved in awkward discussions with some customers as to, in the event of a transgression, how any responsibility is allocated and risk mitigating steps be put in place: Without any clear traceability data it is unclear where any problem occurred and how to avoid it happening again.
Anne-Marie decides that it is prudent to gather some statistical evidence, both for some existing regular shipments as well as some trials involving new products and emerging markets (where 3rd party couriers are required with whom her company has no previous experience).
Using the existing polystyrene packaging and in some cases ice packs being added on despatch, Anne-Marie arranges for Smashtag Chill devices to be stuck on 1) product at the centre, 2) around the inside periphery, and 3) on the outside of the packaging to monitor the environmental surroundings.
Smashtag Chill proves an easy-to-use way of gathering valuable data, whether the data is uploaded to the Cloud by the customer or the device returned to Anne-Marie for her to interpret. Safely and securely, Anne-Marie soon has structured traceability data showing detailed temperatures profiles.
Anne-Marie is able to make a number of recommendations, in some cases to add additional thermal insulation during Summer or for longer routes, in others to review data with the couriers and explore with them alternative practices, and in some cases the scope to actually reduce the level of packaging.
Many existing customers find the assurance given by Smashtag Chill, together with its ease-of-use to be sufficiently attractive that they negotiate for it to be mandated as included in their contracts - and an on-going data trail is established to monitor vaccine shipments from Anne-Marie’s company.