Preservation of Polypropylene Medical Plastics during Sterilization by Ampacet ProVital+ Gamma-Protect
In the medical industry, maintaining the integrity of materials during sterilisation processes is crucial. Ampacet, a global leader in masterbatch solutions, has introduced a range of new products to address this challenge.
Ampacet's latest offering includes ProVital+ Gamma-Protect, a medical-grade additive designed for polypropylene-based medical and pharmaceutical articles. This product is designed to preserve mechanical and optical properties during gamma and e-beam sterilisation processes, where unstabilised polypropylene is particularly susceptible to degradation and discoloration.
ProVital+ Gamma-Protect has been pre-evaluated for biocompatibility according to ISO 10993 part 5, 10, and 23, ensuring it meets the necessary safety standards for medical applications. It is applicable in various fields including medical devices, in-vitro diagnostic equipment, and pharmaceutical packaging systems.
Manufacturing of ProVital+ Gamma-Protect is under consistent process parameters and cleanroom production to minimise cross contamination risks.
Another addition to Ampacet's portfolio is ProVital+ Permstat, a medical-grade permanent antistatic masterbatch. This product is applicable in the medical industry and helps manage static charges that can potentially harm sensitive medical equipment or products.
Ampacet has also launched the ProVital+ LaserMark portfolio, designed for use in the medical industry. This portfolio offers solutions for laser marking on medical devices and components, providing a safe and effective method for identification and traceability.
The preservation of polypropylene's properties during sterilisation processes primarily relies on the use of stabilisers and antioxidants. Key types of medical-grade additives suitable for this purpose include antioxidants, UV stabilisers, radiation stabilisers, and heat stabilisers.
Antioxidants help prevent oxidative degradation caused by radiation exposure, maintaining mechanical strength and clarity. Radiation stabilisers, such as phosphites and hindered amine light stabilisers (HALS), can scavenge free radicals formed during gamma and e-beam sterilisation, preserving polymer integrity. UV stabilisers, although more related to preventing sunlight-induced degradation, also offer some protection against radiation damage. Heat stabilisers help maintain thermal stability during sterilisation.
While the necessity of such stabilisers to preserve PP's properties under these sterilisation methods is highlighted, the search results do not explicitly list individual medical-grade additives for polypropylene in gamma and e-beam sterilisation. However, their selection involves careful compatibility and biocompatibility analysis as part of the sterilisation process validation.
In summary, to preserve mechanical and optical properties of polypropylene during gamma and e-beam sterilisation, medical-grade antioxidants and radiation stabilisers are typically employed, often combined with heat and UV stabilisers, to protect against polymer chain scission, discoloration, and property loss. These additives can influence the final product's safety and regulatory acceptance, making their selection a critical aspect of the sterilisation process.
Ampacet's new products, ProVital+ Gamma-Protect, ProVital+ Permstat, and ProVital+ LaserMark, are all designed to address specific challenges in the medical industry, contributing to the development of safer and more reliable medical products.
- Ampacet's new product, ProVital+ Gamma-Protect, is a medical-grade additive specifically designed for polypropylene-based medical and pharmaceutical articles, preserving their mechanical and optical properties during gamma and e-beam sterilisation processes.
- In the health-and-wellness industry, where finance plays a significant role, the selection of medical-grade antioxidants and radiation stabilisers is a critical aspect of the sterilisation process, as these additives can influence the final product's safety and regulatory acceptance.
- ProVital+ Permstat, another addition to Ampacet's portfolio, is a medical-grade permanent antistatic masterbatch, applicable in the medical industry, helping manage static charges that can potentially harm sensitive medical equipment or products.
