Ampacet ProVitalTM+ Gamma-Protect preserves polypropylene-based medical plastics during sterilization process

Gamma and E-beam sterilization – benefits as well as challenges for polymers

Gamma and e-beam sterilization techniques are commonly used by the medical industry to eliminate microorganisms such as bacteria, viruses and spores from medical devices, in-vitro diagnostic equipment and packaging systems. However, gamma and e-beam sterilization methods are known to alter the optical and mechanical properties of the polymers, including elongation, tensile and impact strength.

Where can the additive be used?

Ampacet ProVitalTM+ Gamma-Protect is an efficient medical grade additive solution that stabilizes polypropylene during gamma or e-beam sterilization processes and helps to preserve mechanical and optical properties and prevent degradation of the polymer. Applications include medical devices, in-vitro diagnostic equipment and pharmaceutical packaging systems.

Biocompatibility assessment

Ampacet ProVitalTM+ Gamma-Protect has also been successfully pre-evaluated for biocompatibility according to ISO 10993 part 5, 10 and 23 (cytotoxicity, sensitization and irritation) at a letdown ratio of 5%.

Formulation consistency and minimize risks

Ampacet ProVitalTM+ Gamma-Protect provides full consistency of formulation with a no-change policy for raw materials at CAS and commercial levels, with manufacturing under consistent process parameters and cleanroom production to minimize cross contamination risks.

Contact for questions about the ProVital™+ range

For more information on the Ampacet ProVital+ range, email marketing.europe@ampacet.com, or visit us at Pharmapack booth 4G92 (21-22 January, Paris, France).