Is closed processing a reality?

Somasundaram G, Senior Consultant – Asia Pacific, Global BioPharm Centre of Excellence, Process Solutions, Merck KGaA and Priyabrata Pattnaik, Director, End-to-End Solutions – Asia Pacific, Process Solutions, Merck KGaA define the key drivers for adopting closed processing, detail the pros and cons of closed processing and some innovations happening in this sphere

Somasundaram G, Senior Consultant – Asia Pacific, Global BioPharm Centre of Excellence, Process Solutions, Merck KGaA

Closed processing is considered to be a logical extension of single-use and involves the use of physical barriers to separate processing fluid from the external environment, including the operators. Materials enter or leave the system via predetermined control points.

International Society for Pharmaceutical Engineering (ISPE) defines it as, “A process condition when the product, materials, critical components, or container/closure surfaces are contained and separated from the immediate process environment within closed/sealed process equipment. A process step (or system) in which the product and product contact surfaces are not exposed to the immediate room environment.” In this article, we will define the key drivers for adopting closed processing, what are the pros and cons of closed processing and how some of the innovations are happening in this direction.

Is closed processing the same as connected processing?

Biomanufacturing is steadily moving towards higher efficiency through process intensification. One of the key aspects of intensification is operational excellence through connected processing, resulting in functionally closed bioprocess. The advantages of closed processing are shorter processing time, less manual interactions in the process, reduced CAPEX, reduced resources for cleaning and validation, and reduced need for qualified manufacturing space.

Drive to go for closed processing