News & Events
Stay on top of industry related information, news and events.
ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
ISO 11607-1:2006/Amd 1:2014
ISO 11607-1:2006/Amd 1:2014 specifies the requirements and test methods 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.
Cold Chain Guidance for Medicinal Products
Medicinal products requiring controlled temperature storage should be transported by appropriately specialized means to ensure product quality is not adversely affected during transport. These products may be shipped outside of their respective label storage conditions provided stability data exist demonstrating that product quality is not affected.