Medical Device Packaging Solutions

The package is advertising for the brand. An effective package for the pharmaceutical or medical device industry needs should verify the quality of seals and overall packaging for stability pack-out samples, as well as insure the integrity of seals and overall packages for clinical trials and production run product, and ensure medication shelf life to deliver safe and effective products to market.

"Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems", part of the International Organization for Standardization ISO 11607-1:2019, gives out the general requirements approaches for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

STEMart offers state-of-the-art technology and facilities to provide packaging solutions for your medical devices. With extensive expertise in consulting, package validations encompassing package and sterilization configurations, material qualification, and package development, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks.

STEMart performs cost-effectiveness full services that deliver reliable results for your medical devices. Our experts can evaluate the medical device to propose an appropriate plan for testing to ensure your medical device meets the required regulatory compliance. If you have any additional questions about Packaging Solutions or would like to consult with the experts at STEMart, please feel free to contact us.

Reference

• ISO 11607-1:2019 "Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems"