The FDA recently held a panel meeting regarding Eto Sterilization. Topics included replacement sterilization methods, reduction in EtO usage, impact of shortages, and reduced SAL requirements. J-Pac is currently adding in-house EtO capacity to help our customers, especially early stage customers, cope with the capacity reduction experienced in the industry. Learn more at https://lnkd.in/fVri6ja
This white paper is meant to identify critical considerations related to WIP Exposure vulnerabilities of resorbable polymers. A structured and disciplined assessment of the different contributors to the Overall Exposure Risk will enable a fact based decision pathway that will result in the establishment of a repeatable and capable manufacturing, packaging and sterilization processes that reduce device degradation. The result will be a consistently performing, efficacious product with optimized shelf life.
Provides a validated QMS solution to accommodate increased regulatory requirements Somersworth, NH (October 11, 2019) – J-Pac Medical, a leading medical device outsourcing partner announced that it has adopted an electronic Quality Management System that seamlessly integrates all of its quality and regulatory compliance processes. The suite of validated, FDA/ISO compliant electronic business processes is […]
Additional Cleanroom Capacity is Due to Market Demand and Growth J-Pac Medical, a leading manufacturing and packaging outsourcing partner to medical companies, has opened a new manufacturing facility in Cartago, Costa Rica. The new facility houses a Class 8 cleanroom and adds capacity for J-Pac to manufacture and package medical devices that require stringent environmental […]
Medical-grade textiles are an ideal component for implantable medical devices, largely due to the product design versatility they offer.