Compounder Americhem will celebrate the expansion of its plant dedicated solely to clean compounding for medical device customers with a virtual ribbon cutting ceremony on April 7, 2021, at 9 AM EST. You can watch the ribbon cutting at Morrisville, PA, live on YouTube.
The Americhem Engineered Compounds (AEC) 60,000-sq-ft plant expansion includes the addition of a 20,000-sq-ft “clean” room that will house six new compounding lines. The new clean environment and AEC Customer Design Center, coupled with Americhem’s existing ISO 13485 certification, gives the company demonstrable credentials 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," said Jim Figaniak, VP and GM of Americhem Engineered Compounds. “It is designed to minimize contamination while producing compounds in a clean, well-lit environment. The AEC Customer Design Center includes pilot-scale production to assist our customers with new product design and small-lot qualification,” added Figaniak.
The clean compounding facility reportedly 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.