July 2009

Novel Improvements to Sanitary Flange Adapters and Fluid Sampling Sites for Single-Use Systems

    Figure 1:   SterilEnz®-II/G connectors and SterilEnz Samplers represent a novel design improvement when compared with common fittings and fluid injection sites. This article briefly discusses the features, benefits, and technical aspects surrounding the design and integrity testing of the SterilEnz product line as well as advantages over their predecessors.   SterilEnz-II/G Flange Connectors and Samplers   Each SterilEnz-II/G connector is hermetically sealed inside a rugged overwrap pouch (Figure 1). The connector is fitted with a pre-attached, medical…

Process Analytical Technology (PAT) in Powder Media Production

Quality control is very often perceived as the last step in manufacturing a product. But quality is not a consequence of quality testing; it must be built into the manufacturing process. At the beginning of the 21st century, the FDA Advisory Committee for Pharmaceutical Science (ACPS) began to address this problem, calling for consistent regulations in designing, analyzing, and controlling pharmaceutical manufacturing processes. As a result, process analytical technology (PAT) was developed providing a framework for innovative pharmaceutical manufacturing and…