Traditional pharmaceutical packaging materials have been refined over decades to provide a high degree of protection for sensitive goods. However, with
technological advancement, new packaging
challenges have arisen which are better solved with
the use of a new generation of materials.
One of the newer materials finding favor in
the packaging of modern pharmaceuticals is the
family of cyclic olefin polymers and copolymers.
These ultra-pure, high-clarity products deliver a
new level of safety and purity, which is ideally
suited for the increasingly complex and sensitive
active pharmaceutical ingredients (APIs) entering
commercial use today.
Wide Range of Industry Offerings with
In healthcare applications, cyclic olefin-based polymers and copolymers (COPs and
COCs, respectively) are available from several
manufacturers. These cyclic olefin materials share
similar monomeric building blocks, and although
each is made via a unique process, the resulting
materials are similar in many ways.
All cyclic olefin plastics share backbones
composed only of carbon and hydrogen, and
thus are intrinsically very inert and non-reactive.
Extractable and leachable profiles of this class of
materials are typically excellent. Optical properties
of cyclic olefin resins are as close to glass as those
of any known plastic. Almost all are very rigid
thermoplastics which can be injection-molded or
extruded to produce packaging items.
Selection of specific cyclic olefin materials is
often based on heat resistance, processing and
property parameters, and cost. In all cases, cyclic
olefins are significantly less prone to breakage than
glass in container
much less and
is of critical
leading sterilization techniques. In general, COCs
and COPs are not impacted by ethylene oxide.
All makers offer grades that can withstand
the temperatures of steam sterilization (at
least 121°C/250°F and in some cases higher).
Some grades also tolerate radiation sterilization
techniques, such as gamma or beta processes.
It is important to confirm specific technique
compatibility with the resin supplier.
Cyclic olefin resins have been extensively tested
for regulatory compliance in pharmaceutical
applications with excellent results. Many grades
are compliant with U.S. and EU Pharmacopoeia,
while suppliers have established drug and device
master files with the FDA. As with sterilization
compatibility, regulatory compliance for specific
grades should always be reviewed with the supplier.
Syringes, Vials, and Wearables: Targeted
Among the leading applications for cyclic olefins is
pre-filled syringes. The high purity of these resins
and the close dimensional tolerances they deliver
New Developments in
Pharmaceutical Packaging Materials
Cyclic olefin copolymers make strong inroads in pharmaceutical packaging.
By Timothy Kneale, President at TOPAS
Advanced Polymers, Inc.