Biomedical Engineering Reference
In-Depth Information
to international standards to demonstrate the ability of the final packaged, car-
toned product to withstand the drops, vibrations, etc. that accompany routine
transportation and handling.
The risks associated with the distribution of biopharmaceutical products are
primarily associated with their temperature sensitivity [32]. Some products
require refrigerated or freezer storage to maintain product quality. In addition,
other products, although stable at ambient temperatures are degraded if exposed
to temperatures exceeding 0 or 30 C, which represent extreme temperatures for
many biopharmaceutical products . Products such as these require controlled
transport conditions to ensure that product degradation does not occur during
the distribution process. Distribution environments are influenced by climate
zone, season, and transportation modality.
A risk assessment of the distribution chain should begin at the manufacturer's
loading dock. There, the product is palletized in its tertiary container and loaded
onto trucks for transport. The risks associated with this step are associated with
rough handling, which may result in crushed cartons and damaged product. Mit-
igations at this step demonstrate that primary and secondary packaging are able
to protect the product.
Once loaded onto trucks, the product is transported to the next stage in the
distribution chain, as shown in Figure 12.8. At this step, there are several risks
associated with the transportation equipment. Transportation vehicles may have
faulty suspensions or mechanical failures that may result in carton and product
damage. Malfunctioning or uncontrolled cooling units may result in temperature
excursions that result in a degraded product. Biopharmaceutical products are often
shipped in qualified insulated containers with cold packs or refrigerated trucks to
ensure that controlled temperature conditions are maintained during the shipping
process.
If being transported to an airport, the product may need to pass through a
Customs inspection, which may add additional time to the transport process
and may exceed qualified times for product cooling containers, thus resulting in
potential temperature excursions and degraded product. Once through Customs,
the product is loaded onto an airplane where it may subjected to rough handling,
with risks that are similar to being loaded onto a truck. While in transit on the
airplane, the cartons can experience turbulence, engine vibrations, and pressure
changes all of which have the potential to impact the cartons and result in product
damage. Thorough testing of primary and secondary packaging is required to
insure adequate protection of the product.
Failure modes similar to those already discussed are again present as the
product is unloaded from the aircraft, loaded onto trucks, and transported to
distribution centers. The same mitigations apply in these circumstances.
The final step in the distribution chain is the transport from a local hospital
or pharmacy to the patient's home. This may occur via public transportation or
personal automobile. At this step, the product is outside of the manufacturer's
control, but must still be protected against rough handling and temperature excur-
sions. Mitigations at this step rely on well-designed packages to protect the
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