Company insight
Breaking glass T
he glass syringe has been the mainstay in the administration of parenteral medicines due to its chemical resistance, high heat tolerance, and transparency. But in an ever-evolving medical device market, syringes made from glass-like thermoplastics are becoming an increasingly attractive option. One such material called cyclo olefin polymer (COP) offers the same benefits of glass but has additional clinical and cost- effective advantages. With the many COP syringe manufacturers available, it’s essential to find a premium syringe that meets your diverse needs. A leading candidate in the syringe market, Merit Medical’s COP Syringe is a high-quality product that surpasses its competition – and customer expectations.
COP science and special characteristics COP is a transparent, amorphous thermoplastic derived from norbornene, a ring-shaped hydrocarbon made from dicyclopentadiene (DCPD) and ethylene. COP’s unique chemical structure yields a material that’s lightweight yet durable. Unlike glass, a COP syringe is less likely to break in the hand of a clinician or during transportation, potentially reducing the risk of injury and preventing wastage of costly medicines.
A leading manufacturer and marketer of proprietary disposable medical devices, Merit discusses how cyclo olefin polymer syringes are becoming the go-to syringe.
fragrances. A resin that retains a high level of purity, COP has low residual metals that measure less than 0.02ppm. When compared with glass, COP is considered a low- leachable alternative. A 36-month leachable study on water for injection in direct contact within
a COP pre-fillable syringe showed no difference in leachable amounts between COP and glass. Additional comparison extractable studies have resulted in COP displaying element extractable values lower than glass, suggesting COP is a viable alternative that can achieve very low-level extractable profiles. One of COP’s most significant properties is its robust moisture barrier that shields its contents from the effects of humidity and oxygen. Data show COP absorbs water at an ultra-low rate of less than 0.01% over a 24-hour period. Virtually impenetrable, COP can protect against moisture loss in
“A leading candidate in the syringe market, Merit Medical’s COP Syringe is a high-quality product that surpasses its competition – and customer expectations.”
Boasting high resistance to chemicals and heat (212–374°F Tg), COP is a practical container option for expensive drugs that are sensitive to syringe material. COP can withstand a broad pH range of two to 12, offering good resistance to acids, bases, alcohols, and
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pre-filled materials, which can lengthen the shelf life of drugs. This is significant because, just like glass, COP syringes can store liquids for several years. Because of COP’s high-quality, glass-like transparency, any visible changes to pre-filled content can be detected.
COP pre-fillable syringe is considered a low- leachable alternative to glass syringes.
COP pre-filled syringes: Clinical applications
COP is often used to package biotech injectables that are costly and sensitive to their environment. Hyaluronic acid – a common glycosaminoglycan found throughout human tissue and used in orthopedics, cosmetic surgery, and ophthalmics – is an example of a product that calls for the high-quality packaging that pre-filled COP syringes offer. From dermatology to dentistry, the potential that COP pre-filled syringes have in a variety of other clinical settings is noteworthy.
For example, aqueous sodium hypochlorite solution used during root canal treatments is often packaged in pre-filled syringes. Reports show the percentage of flu vaccine packaged in pre-filled syringes has more than doubled from 21% during the 2006–7 flu season to 48% during 2012–13.
Medical Device Developments /
www.nsmedicaldevices.com
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