Transport boxes: Shippers & Vacutainers
Robust “shippers” are used to transport smaller batches of Erbitux®. These well-insulated polystyrene cartons were specially developed and tested for the transport of medications. They hold more than just the drug packages: Cooling elements and “dataloggers” (see below) are placed in the cartons before they are closed and sealed. This is how Merck guarantees that the product is protected and that the cold chain is maintained for periods of up to five days. “Vacutainers” guarantee the same for the transport of large batches of Erbitux®: These aluminum boxes can hold entire pallet-loads.
Shipping companies that want to transport highly sensitive pharmaceutical products such as Erbitux® must first qualify for comprehensive certification. To gain this certification they must document the quality management system they use, their methods of training their employees, and how they calibrate their refrigeration units. In addition, the refrigerated trucks they use to transport the Erbitux® batches must undergo a visual inspection and smell test performed by Merck employees every time they are used.
Each shipper and Vacutainer contains a datalogger. Dataloggers are microchips that measure and document ambient temperatures every few minutes — for up to seven days, around the clock. It works something like a tachograph in a car for documenting speed. Merck uses the dataloggers to document the temperatures the medication was exposed to during the entire duration of the trip, from the cold storage warehouse to the pharmacies and patients.
Robust “shippers” are used to transport smaller batches of Erbitux®. These well-insulated polystyrene cartons were specially developed and tested for the transport of medications. They hold more than just the drug packages: Cooling elements and “dataloggers” (see below) are placed in the cartons before they are closed and sealed. This is how Merck guarantees that the product is protected and that the cold chain is maintained for periods of up to five days. “Vacutainers” guarantee the same for the transport of large batches of Erbitux®: These aluminum boxes can hold entire pallet-loads.
Certified shipping companies
Shipping companies that want to transport highly sensitive pharmaceutical products such as Erbitux® must first qualify for comprehensive certification. To gain this certification they must document the quality management system they use, their methods of training their employees, and how they calibrate their refrigeration units. In addition, the refrigerated trucks they use to transport the Erbitux® batches must undergo a visual inspection and smell test performed by Merck employees every time they are used.
Electronic monitoring: Dataloggers
Each shipper and Vacutainer contains a datalogger. Dataloggers are microchips that measure and document ambient temperatures every few minutes — for up to seven days, around the clock. It works something like a tachograph in a car for documenting speed. Merck uses the dataloggers to document the temperatures the medication was exposed to during the entire duration of the trip, from the cold storage warehouse to the pharmacies and patients.
En route to a temporary storage facility, reusable dataloggers handle this task. The recipient records the delivery time by means of a special data terminal on the microchips and then immediately sends the dataloggers back to Merck, where all the data is read out, checked, and archived. This enables the manufacturer to follow the distribution route right away and also over longer periods.
And pharmacies in turn are kept informed about the state of Erbitux® via single-use dataloggers. This means that upon receipt of the product they can immediately determine whether or not the cold chain has remained stable since the medication left the distributing warehouse. Only when this has been confirmed can the product be dispensed to patients. And the datalogger then involves no further effort: Afterward it can simply be discarded in the trash.
