Preservation of sterilized polypropylene-based medical plastics by Ampacet's ProVital+ Gamma-Protect solution
In the ever-evolving medical industry, ensuring the durability and safety of medical devices, in-vitro diagnostic equipment, and pharmaceutical packaging systems is paramount. Ampacet, a global leader in masterbatch solutions, has recently announced a series of innovative products designed to meet these demands.
One of the standout introductions is ProVital+ Gamma-Protect, a medical-grade additive designed to preserve the mechanical and optical properties of polypropylene (PP) during gamma and e-beam sterilization. These sterilization methods, commonly used by the medical industry to eliminate microorganisms, are known to alter the optical and mechanical properties of polymers, including elongation, tensile, and impact strength.
ProVital+ Gamma-Protect employs a blend of additives, each serving a unique role in maintaining the polymer's integrity. These include UV stabilizers such as hindered amine light stabilizers (HALS), antioxidants, fillers and reinforcers, and radiation stabilizers.
HALS and antioxidants are primary additives for radiation stability, inhibiting oxidation reactions and preventing PP degradation caused by radiation-induced free radicals. Fillers and reinforcements, like glass fiber, carbon fiber, mineral fillers, or natural fiber reinforcements, indirectly help maintain mechanical properties and thermal stability during sterilization. Radiation stabilizers, such as phosphites or hindered phenol antioxidants, are not explicitly detailed but are known to prevent chain scission or crosslinking from ionizing radiation.
In addition to ProVital+ Gamma-Protect, Ampacet has launched ProVital+ Permstat, a medical-grade permanent antistatic masterbatch, and ProVital+ Colors, medical-grade color masterbatch solutions. The ProVital + LaserMark portfolio, designed for laser marking in medical applications, has also been introduced.
All these products are manufactured under consistent process parameters and cleanroom production to minimise cross-contamination risks. ProVital+ Gamma-Protect has been pre-evaluated for biocompatibility according to ISO 10993 part 5, 10, and 23 (cytotoxicity, sensitisation, and irritation) at a letdown ratio of 5%. This ensures these innovative solutions are fit-for-use post-irradiation sterilization.
The applications for these new products are vast, ranging from medical devices and in-vitro diagnostic equipment to pharmaceutical packaging systems. With Ampacet's latest offerings, the medical industry can now rely on enhanced sterilization resistance, clarity, strength, and durability for their critical applications.
Medical devices and medical-grade plastics, such as ProVital+ Gamma-Protect and ProVital+ Permstat, are innovative solutions from Ampacet that cater to the demands of the medical industry. These products, developed using science and technology, are designed to enhance sterilization resistance, clarity, strength, and durability for various applications, including in-vitro diagnostic equipment and pharmaceutical packaging systems.
