The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular therapeutics, has driven steady investment in facilities capable of manufacturing these therapeutics at scale . Meanwhile, the industry is collectively moving to adapt to European Union Annex 1 standards, which places a more stringent emphasis on contamination control.
Welds used in biopharmaceutical manufacturing must meet critical criteria to maintain a defined level of purity and bioburden control. One highly debated area of concern is the level of discoloration allowable on the product contact surfaces in the welded condition and secondary finishing methods. This article addresses the studies commissioned by the American Society for Mechanical Engineers...