Tag: Biomaterials

Tissue Bank – Allograft

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The Challenge

A Tissue Bank approached J-Pac Medical to provide a customized sieve/filter fabricated from medical grade textile mesh to be utilized in a specific tissue demineralization process

Current practice required engineers to fabricate a commercial mesh as needed to enable the particular process step.

The company wished to implement a quality improvement by upgrading to a medical grade mesh, and also to redesign and validate a process to provide the needed sieve/filter.

Our Solutions

J-Pac Medical identified an appropriate mesh alternative for the company, and also suggested specific fabrication methods that enabled the redesign and implementation of an improved sieve/filter.

This component is provided in a double barrier pouch put-up, and is terminally sterilized via Eto by J-Pac Medical.

The Results

The company improved tissue quality and regulatory compliance by ensuring medical grade processing, biocompatibility, and lot traceability.

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FDA Panel Meeting Regarding Eto Sterilization

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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

New Whitepaper: Resorbable Polymer Implants

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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.

Read the White Paper

J-Pac Medical Announces Implementation of Electronic Quality Management System

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 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 designed to comply with strict regulatory requirements and enable industry best practices.

“Implementing an electronic Quality Management System takes our compliance system to the next level in order to better serve our medical device customers,” said Jeff Barrett, President and CEO. “The new system will allow us to maintain regulatory compliance while we continue to grow. Our customers are increasingly outsourcing more medical device assembly and packaging while regulatory requirements continue to become more burdensome. The new system gives customers peace of mind and allows us to scale our business while ensuring compliance to FDA and ISO regulations.”

 About J-Pac Medical

J-Pac is an ISO 13485:2016 certified supplier of assembled, packaged and sterilized medical and diagnostic devices. J-Pac is a manufacturing solution for both large and small medical device and diagnostic companies that need a one-stop manufacturing partner for single-use medical devices, biotextile products, and point-of-care diagnostic consumables.

For more information contact:

Todd Oehlerking
Director, Sales

toehlerking@j-pacmedical.com

603-692-9955

J-Pac Medical Increases Manufacturing Capacity with New Costa Rica Facility

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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 controls. The expansion will allow J-Pac to reduce the lead time of projects, stay cost-competitive in the Medtech industry, and open business opportunities outside the United States.

“Opening this new facility is a direct result of J-Pac’s growth and an increase in demand for high volume, cost-effective production,” said Jeff Barrett, president and CEO of J-Pac Medical. “Safety and quality are our highest priority. We selected Costa Rica for our expansion due to the highly skilled workforce and favorable business climate.”

About J-Pac Medical
J-Pac Medical is a manufacturing outsourcing partner to medical device OEMs seeking a faster time-to-market and dependable long-term supply. We specialize in single-use medical devices, biomaterial implants, and lab-on-a-chip diagnostic consumables. J-Pac delivers a validated end-of-line solution for package design, cleanroom assembly, sterilization, and supply chain management. We are FDA registered and certified to ISO 13485:2016. Learn more at j-pacmedical.com.