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This Americhem Engineered Compounds, or AEC, plant expansion includes the addition of an isolated 20,000 sq. ft. “Clean Compounding” room that will house six new compounding lines in the overall 60,000 sq. ft. expansion. The new clean environment and AEC Customer Design Center, coupled with Americhem’s existing ISO 13485 Certification, gives AEC unique capabilities to produce compounds that meet the most stringent medical device requirements.
“Our medical compounding process is performed in our GMP production area, which ensures that all of our medical grade polymers and compounds will be made to the highest quality standards. It is designed to minimize contamination due to airborne contaminant and other contamination, while producing compounds in a clean, well-lit environment,” states Jim Figaniak, VP & GM of Americhem Engineered Compounds. “The AEC Customer Design Center includes a pilot scale production to assist our customers with new product design and small lot qualification.”
“Our Clean Compounding facility is the largest of its kind and includes an air lock with a positive pressure environment, HEPA filtered air exchange with humidity and temperature controls, epoxy coated floors to allow for easy cleaning, and sealed and polished warehouse floors” states Jim Figaniak.
To celebrate the completion of their plant expansion dedicated solely to clean compounding for medical device customers in Morrisville, PA, Americhem Engineered Compounds hosted a virtual ribbon cutting on April the 7th.
