Medical Design Briefs - October 2023 - 6

Small Particles, Big Impact:
Addressing the Dangerous
Implications of Micro
Material Contamination
P
harmaceutical
drug products
are carefully engineered,
manufactured,
and administered
with patient
safety, drug efficacy,
and business success
in mind. Drugs
and the components
they are packaged
in are subject
to strict regulations and requirements, including
sterilization and comprehensive
quality review and testing. While pharmaceutical
manufacturers consistently work
to mitigate any substances or processes
that could hinder ultimate quality, small
particles still pose a challenge to the industry.
With this in mind, companies must
take proactive steps to mitigate particle
contamination's impact on the sensitive
drugs that are critical to the health and
safety of patients and company success.
Katie Falcone, Datwyler
n Particle Impact
Particles can be foreign substances inadvertently
introduced to a pharmaceutical,
which can then directly enter the
human body through administering a
pharmaceutical drug. The source of particles
can include human skin and hair
particles, cellulose fibers, or even metal
fragments resulting from different stages
of the manufacturing process. While
many drugs may contain trace levels of
particles that are not considered harmful
to a patient, particles can have a drastic
impact on the patient once a drug
enters the bloodstream. To understand
the impact of these particles, it is important
to look at the pharmaceuticals to understand
how small particles can have
such a major impact.
Biologics are proteins carefully formulated
from biological sources. When any
foreign particles are introduced, those
particles can interact with the proteins to
denature them, rendering them ineffective.
Through the denaturing process, the
active pharmaceutical ingredient is lost,
resulting in a patient not receiving the intended
dose, directly affecting the desired
therapeutic effect and treatment process.
6
In addition to the effects particles
can have on patient safety and the sterility
of drug products, particle contamination
can have major business
and financial implications for pharmaceutical
manufacturers. If particles are
found to have contaminated the entire
batch, then the entire batch must be
scrapped resulting in financial loss to
the manufacturer. Digging even further,
scrapping entire batches of products
has an impact on a company's
sustainability efforts. Throwing out
batches of products results in a waste of
energy it took to make the drug product,
a waste of fuel it took to transport
the product, and a pile up of scrapped
vials, stoppers, expensive drug products
that cannot be used. While there
are currently regulations in place to
mitigate these impacts, companies can
still experience issues that impact patient
safety and business success.
quality control processes to ensure preventative
measures are in place to decrease
potential contaminations, recalls,
and costly issues for customers. The call
for quality is always increasing - companies
are constantly striving to do better,
and even exceed the already tight regulatory
standards. By implementing strict
quality control measures, companies
place even more of an emphasis on sterilization,
safe shipping and storage, and
proactive thinking to mitigate any opportunities
for infiltration of foreign particles.
By adopting a forward- thinking, innovative
mindset, pharmaceutical manu
facturers can focus on ways to reduce particle
contamination, and always stay
ahead of the regulations curve.
n Innovation in the Industry
With the multitude of implications
While there are currently regulations in place to mitigate
impacts, companies can still experience issues
that affect patient safety and business success.
n Implications in Today's World
Regulations in the pharmaceutical industry
are strict and ever-evolving, especially
when it comes to patient safety.
Over the years, companies have begun
placing a heavier emphasis on testing for
and reducing particles. Pharmaceutical
manufacturers have been particularly
challenged with producing high-quality
products while fulfilling quick turnaround
times for COVID-19 vaccines.
With manufacturers working against
high levels of demand, there is little
room for batch contamination issues,
which can be detrimental to companies
and their customers, in terms of finances
and the health of patients. Companies
such as Datwyler implement rigorous
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and concerns over particles, even after
adhering to industry regulations, it may
be overwhelming for pharmaceutical
manufacturers to determine how to
move forward. Fortunately, there are still
measures companies can implement to
mitigate particle contamination. Datwyler's
DuraCoat™ combiseals incorporate
a protective lacquer on the aluminum
shells to reduce the opportunity for aluminum
particles to form. Aluminum
shells can easily rub together during
transit, causing tiny aluminum particles
to form. From there, the aluminum particles
can then transfer to the elastomer,
which has primary contact with drug
products. Incorporating the protective
lacquer reduces the opportunity for particles
to form.
Our households, the air we breathe,
and the food we consume all contain
particles. However, one of the most dangerous
places for unwanted particles to
exist is in pharmaceutical drug products
and items that help keep patients
healthy. By auditing company processes
and incorporating innovative thinking,
pharmaceutical manufacturers can work
to reduce particle contamination across
the supply chain, resulting in positive impacts
to companies, their customers, and
patients around the world.
This editorial was written by Katie
Falcone, Scientific Support Manager,
Datwyler, Middletown, DE. Datwyler develops,
designs, and manufactures solutions
for injectable packaging and drugdelivery
systems. For more information,
visit www.datwyler.com.
Medical Design Briefs, October 2023
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Medical Design Briefs - October 2023

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