Biomedical Engineering Reference
In-Depth Information
12.3.8.2 Quality Risk Management and Extractable/Leachable Concerns
Extractables and leachables may interact with biopharmaceutical products
causing degradation of the molecule, thereby impacting product performance.
This may be addressed by careful selection and characterization of processing
aids and packaging materials. Table 12.3 describes the factors that should be
considered in terms of biopharmaceutical compatibility and product performance.
12.3.9 Distribution and Cold Chain Supply
12.3.9.1 Process Overview Distribution processes for biopharmaceutical prod-
ucts can be very complicated. They extend from the loading dock of the phar-
maceutical manufacturer to the patient (Fig. 12.8).
From the manufacturer, products can be delivered either via air or local
highway transport to distribution centers, or, in the case of local highway
transport, directly to hospitals and pharmacies. From the distribution centers
products may be further transported to hospitals and pharmacies or, in the case
of specialty services providers, the product may be repackaged and delivered
directly to a patient. Patients may also receive products from local hospitals and
pharmacies in which case they themselves transport the product home via local
transport, for example, automobile or public transport.
The distribution chain is subject to variations that manufacturers are unable
to control and thus cannot be validated. However, manufacturers may qualify
portions of the distribution chain, for example, shippers, warehouses, etc. A typ-
ical approach would be to qualify primary, secondary, and tertiary packaging to
demonstrate its ability to protect the product during rough handling/condition.
Tertiary packaging may include cooling units and be qualified to prove the ade-
quacy of those units to ensure that the product is not exposed to temperature
excursions during transport. Generally, distribution tests are executed according
Highway transport
Air transport
Distribution
center
Hospital
Factory
Carry home
Patient
Pharmacy
Highway transport
Figure 12.8 Typical distribution chain. ( See insert for color representation of the figure .)
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