Preservation of gamma-irradiated polypropylene medical plastics through the use of Ampacet ProVital+ Gamma-Protect technology.
In a significant development for the medical industry, Ampacet, a global leader in masterbatch solutions, has launched ProVital+ Gamma-Protect. This innovative product is designed to preserve the mechanical and optical properties of polypropylene-based medical and pharmaceutical articles during gamma and e-beam sterilization.
ProVital+ Gamma-Protect is a crucial addition to Ampacet's expanding ProVital+ portfolio, which caters to the unique needs of the medical industry. The product is pre-evaluated for biocompatibility according to ISO 10993 parts 5, 10, and 23, ensuring it meets the highest standards of safety and biocompatibility.
The development of ProVital+ Gamma-Protect is a response to the challenge of balancing effective radiation protection with maintaining transparency, mechanical strength, and safety in medical-grade polypropylene. This additive, like other medical-grade additives, employs a combination of antioxidants and radiation stabilizers to mitigate degradation from ionizing radiation.
Hindered phenol antioxidants, phosphite-based secondary antioxidants, UV stabilizers and HALS, and radiation stabilizers or polymeric antioxidants are some common additives used in medical-grade formulations for polypropylene. These additives help maintain polymer chain integrity, reduce discoloration or embrittlement caused by sterilization, and ensure biocompatibility under rigorous sterilization protocols.
ProVital+ Gamma-Protect finds applications in various medical devices, in-vitro diagnostic equipment, and pharmaceutical packaging systems. It is manufactured under consistent process parameters and cleanroom production to guarantee its efficacy and safety.
In addition to ProVital+ Gamma-Protect, Ampacet's ProVital+ portfolio includes ProVital+ Permstat, a medical-grade permanent antistatic masterbatch, ProVital+ LaserMark solutions for marking and coding medical devices and packaging, and ProVital+ Colors, medical-grade color masterbatch solutions offering a wide range of medical-grade colors for plastics.
While ProVital+ Colors, ProVital+ LaserMark, and ProVital+ Permstat are designed to meet the specific needs of the medical industry, they have not been pre-evaluated for biocompatibility according to ISO standards.
Gamma and e-beam sterilization methods are common in the medical industry as they effectively eliminate microorganisms. These techniques, however, can alter the optical and mechanical properties of polymers, including elongation, tensile and impact strength. ProVital+ Gamma-Protect addresses this issue by stabilizing polypropylene during gamma or e-beam sterilization processes and helping to prevent degradation of the polymer.
Ampacet's ProVital+ Gamma-Protect, along with its other ProVital+ solutions, is set to revolutionize the medical industry by providing innovative, safe, and effective solutions for the unique challenges posed by sterilization.
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