Biomedical Engineering Reference
In-Depth Information
What are extractables and
leachables, and how should
they be considered during
validation?
Drug developers and regulators are concerned about the
potentially adverse impact on drug product quality or
safety by chemicals that may migrate into the drug product
from fluid contact process equipment (including SUSs),
final drug product containers, or secondary packaging.
Extractables are chemicals that migrate from fluid contact
materials under exaggerated conditions (e.g., solvent, time,
temperature) and represent a “worst-case” library of
chemicals that could potentially contaminate or interact
with the drug product. Leachables are chemicals that can
be found in final drug product and typically include some
extractables from process equipment as well as from the
final container/closures or packaging along with any
reaction or degradation products of those extractables and
the active drug. The BPSA Guide—
Recommendations for
Extractables and Leachables Testing
, provides a risk-based
approach for determination of extractables and leachables
from single-use process systems that has been recognized
by US FDA CBER reviewers and applied successfully by
several biopharmaceutical manufacturers. See the guide at
What are the options for
disposing of SUSs and
components?
There are a range of disposal options for SUSs; the best
solution will be dependent on the composite and volume
of plastics, local regulations, and available waste treatment
facilities. Although recycling is viewed as environmentally
appealing, it is not amenable to most SUSs due to low
volumes and mixed plastic content. Landfill options for
typical systems include treated, untreated, as well as grind
and autoclave. Incineration is a widely accepted treatment
option in both the United States and Europe that reduces
the volume of waste. Cogeneration is an attractive
alternative that converts the plastic waste into energy that
produces heat or electricity for consumption by individual
facilities or entire communities. Pyrolysis is a relatively
new technology that converts plastic waste into oil that can
be used as fuel. To learn more about the advantages and
disadvantages of each option, please refer to BPSA's
Guide
to Disposal of Single-Use Bioprocess Systems
at
www.
