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What does it mean to be FDA registered?

August 11, 2020

A discussion on the importance of FDA registration to ensure QMS in plastics machining facilities   For businesses and facilities involved in the production and distribution of medical devices, FDA Registration is a requirement to machine or manufacture any plastic material that will be used in the United States medical market.   Therefore, if your manufacturer or machining shop is not FDA registered, start looking for a new facility with... Read More

Machining Ultra-High Molecular Weight Polyethylene (UHMWPE): A Plastics Guide

July 30, 2020

Source: Plastics Today Ultra-high molecular weight polyethylene (UHMWPE) is part of the umbrella of polyethylene thermoplastics. Other peers include low-density polyethylene (LDPE) and high-density polyethylene (HDPE). Although UHMWPE embodies many similar qualities as HDPE, it is much stronger and carries a significantly higher resistance to chemicals, wet environments and withstands abrasion 15 times greater than carbon steel. This is why, among its many applications, it is the most common material... Read More

Machining Polycarbonate (PC): A Plastics Guide

July 3, 2020

An Informational Brief on Polymer Machining   Polycarbonate, one of the oldest known polymers, was first discovered in 1898 by Alfred Einhorn at the University of Munich. It was not until 1953 that Bayer patented the first linear polycarbonate and branded it as "Makrolon". Ever since then, this material has become one of the most commonly used polymers across multiple industries.   Known for its durability, stability and clarity, polycarbonate... Read More

What Does It Mean To Be ISO 13485:2016 Certified?

May 26, 2020

A discussion with the plastics pros at AIP on how the ISO 13485:2016 standard improves quality assurance for medical machined plastics.   What sets a quality management system (QMS) above the rest for medical device manufacturing and machining? Safety, sanitation and product integrity are, without a doubt, crucial for any plastics machining company working with materials for medical use.   How can you ascertain the validity of a company's QMS?... Read More

Machining Polypropylene (PP): A Plastics Guide

May 18, 2020

An Informational Brief on Polymer Machining   Since it was first polymerized in 1954 by Karl Rehn and Giulio Natta, polypropylene (PP) has become one of the leading polymer choices for a wide array of applications from automotive to commercial to medical.   Polypropylene plays a significant role in medical applications due to its high chemical resistance, lightweight, radiolucency and repeated autoclavability. Furthermore, medical grade PP exhibits good resistance to... Read More

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