Over the past 100 years, DSM has partnered with companies throughout the world to create countless products. Today, we’re partnering
with medical device companies like yours, enhancing your ideas by offering the broadest portfolio of materials in the industry.
Biomedical Polyurethanes and Polyethylenes | Resorbable Polymers | Metals | Bioceramics | Collagens | Device Development
Extracellular Matrices | Silicone Hydrogels | Coatings | Drug Delivery Platforms
installed in-house, in-line with assembly, enabling
sterilization as a part of the production line.
This makes bringing sterilization in-house easy
and safe, and results in faster turnaround times,
increased productivity, and reduced costs.
One important difference between terminal
sterilization with NO2 compared to EO or
radiation processes is that the NO2 process is
completed after the product is sealed in the sterile barrier packaging and before loading in secondary packages (e.g., boxes). The NO2 process
is not compatible with cellulosic materials such
as paper. However, sterilizing products prior
to placing in large cardboard cartons increases
the density of the load, in terms of devices per
volume, increasing the efficiency of the process.
Device Design — Physical design, size, shape,
surface texture, and geometric complexity can
place constraints on sterilization options. As a
non-condensing gas, NO2 can be an excellent
choice for room-temperature sterilization of
challenging devices, such as lumens, needles, and
similar geometries. Understanding the gas path
is important as the sterilant gas needs to have access to all surfaces of the device. NO2 sterilization
process parameters can be adjusted to assist in
driving the sterilant into the medical device load.
Material Selection — Noxilizer has tested a
broad range of medical device materials (see sidebar), with many showing no degradation and no
increase in cytotoxic response. Furthermore, NO2
is less oxidative than other sterilants. As with all
methods, NO2 has a few material compatibility
issues, however these may generally be overcome
through the selection of alternative materials
during the product development process.
Packaging — NO2 sterilization is compatible
with commonly used sterile barrier packaging
including Tyvek pouches, Tyvek/Mylar pouches,
and thermoform trays with Tyvek lids. Rapid
sterilization processes are more sensitive to adhesive coatings on Tyvek. These coatings need to
be evaluated during the development of the sterilization cycle. Also, labels can hinder the gas from
passing through Tyvek layers. Where possible,
labels should be added after sterilization.
The growing complexity of medical and drug delivery devices presents challenges in the selection
of an appropriate sterilization process. Manufacturers with complex or sensitive products now
have another tool in the sterilization toolbox.
NO2 delivers safe, room-temperature sterilization
with a broad range of material compatibility
and low levels of residuals using a rapid, efficient
process. Considering NO2 among sterilization
alternatives early in product design will provide
greatest benefits to designers and manufacturers.
NO2 Compatible Materials*
Cyclic Polyolefins (e.g., COC and COP)
Pharmaceutical Rubber Compounds
Polyester (e.g., PET/PETG)
Two Part Epoxies (non-urethane)
PEEK / PAEK
Conformal Coatings (e.g., Parylene)
*This list is not exhaustive.