Watching Oscar Pistorius sprint on prosthetic legs can make
modern medical devices appear far removed from more traditional manufactured
products.
Certainly,
it can be difficult to connect the production of Oscar’s blades or high-tech devices
that aid cataract surgery, for example, to the manufacture of metal brackets or
kitchen sinks.
Yet, both
medical device and traditional manufacturers must develop good manufacturing
practices (GMP) that include appropriate, designed-in user
interfaces, adherence to regulations,
and quality assurance processes that include worker health and user safety.
When it
comes to medical device fabrication, a key concern of the Federal Drug
Administration (FDA) is contamination, so regulations address a range of
issues, including building design, employee training, and environmental
controls.
4 Sentry Air customers
This blog
profiles 4 customers who desired clean air in their manufacture of medical
products and the Sentry Air products that solved their problems.
1-Epoxy and adhesive fume control
Bulow
Biotech Prosthetics fabricates
functional and cosmetic prostheses for
individuals who suffered amputation of an extremity.
They
produce their custom prosthetics, using epoxies and adhesives that off-gas, in
a typical office building where installation of a ducted fume ventilation
system was bid at over $23,000.
Instead of
going that route, Bulow Biotech purchased a Sentry Air Model 400 Dual Arm Fume
Extractor and positioned it on a shelf over the adhesives work bench.
is very quiet and works so
well that it is difficult to smell any trace of
chemical
in our laminating room where all resins and adhesives are used,”
Kirk Simendinger, Certified
Prosthetist.
[Photo: Bulow Biotech Prosthetics]
Their
experience left them “very
impressed with the efficiency, noise level and price of a unit that does a
wonderful job of making our work environment safer and more enjoyable to work
in.”
The Model SS-400-FSD
is typically equipped with heavy-duty casters and flex-arms capable of 360 degree rotation and is used in a variety of
medical and industrial applications.
2-Extracting adhesive
and solvent fumes
A
manufacturer
of equipment for MRI systems used two Sentry Air dual-arm fume extractors to
improve process flow. Process flow is a key consideration of GMP because it
defines key process steps and affects workers, equipment and materials.
They
use one Model
# SS-450-FSD Dual-Arm Fume Extractor to captures fumes created in
their adhesive application process and a second unit to remove strong fumes
created in their cleaning process.
"Prior to using the Model 450, our adhesive application
process
was located far from our production line because the fumes were
very
strong. The use of the Model 450 allowed us to move the
process back to our
production line and has dramatically
improved process flow.”
3-Dust Control
Argentum
Medical, LLC produces products that use silver-coated fabric, used in the
treatment of wounds, burns and some surgical procedures. They wanted to reduce
the particulate count, produced primarily by the fabric in use, in their
production facilities.
They chose two Model
2000 Free-Hanging Air Cleaners. These ambient-air, dual-stage filtration
systems reduced particle counts by as much as 90%.
“After
installing the Sentry Air free hanging system my
worries were over. The
particulate count has not
been over
500,000 and most of the time it is below
300,000,"
Jeanette Cantrell, Operations
Manager.
4-Biomaterial manufacturing via cell
culturing
Ecovative
Design makes products for shipping, construction and automobile
manufacturing from agricultural by-products and fungi. That’s right: they use
mushrooms and the inedible parts of farm crops to produce biomaterials that can
replace petroleum-based foams.
Their
products are not medical products, but their manufacturing processes require
similar high standards for contamination control.
The FDA
provides GMP design examples that limit opportunities for contamination. At
Sentry Air, where clean air for workers and products is our full-time endeavor,
we especially like this solution:
“A small laminar flow unit and
curtains can create a small, but very clean area.”
"The Sentry Air Systems ductless
hoods provided an ideal solution,
rapidly delivering a complete laminar flow
hood that continues
to perform even years after the original purchase,”
Gavin
McIntyre, Ecovative Designs.
Like all Sentry Air standard hoods, the SS-340-PCR fits
on a
standard work bench; no additional furniture is
required. [Photo not related to
Ecovative Designs]
For
information on sanitary work space options for your medical or biological
manufacturing process, give us a call at
1.800.799.4609,
email us at sales@sentryair.com, or fill out this online form to have a Sentry
Air Systems’ Applications Specialist contact you to discuss your process.
Resources
Do It
By Design, An Introduction to Human Factors in Medical Devices
Medical Device Quality Systems Manual
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