Isolation Technology: Current Trends And Challenges

In this Q&A, Comecer's Emiliano Spagnolo discusses the biggest isolation-related issues currently facing the pharmaceutical industry — and explains how the latest generation of isolation technology is helping manufacturers overcome these problems. He also lays out what he thinks are the three keys to selecting the best isolator for a specific application, and introduces us to several emerging technologies that are bringing unique new capabilities to the isolation market.

Please start by giving the reader some background information on Comecer.

Comecer (Costruzioni Meccaniche Certificate) is a world leader in protection technologies, specializing in isolation technology and nuclear medicine. We produce state-of-the art isolation technology equipment for containment and aseptic applications — from R&D to commercial. We work with pharmaceutical companies on tailored projects for the production of isolators in the treatment of toxic and hazardous substances.

Our team is capable of delivering entirely customized solutions. We offer flexible working methods aimed at the highest level of process integration, advanced design and construction systems, and a focus on ergonomics for durability and ease of use. We are experienced in integrating our isolators with several different components used in pharmaceutical laboratories such as autoclaves, vacuum ovens, mixer, filters, reactors, granulators, and scales, as well as in other production areas such as filling lines, dedusters, and metal checks.

From your perspective, what are the most important isolation technology issues manufacturers should address? Manufacturers are always faced with the complex task of balancing protection between the product and the operator, while complying with regulatory norms and limiting operational costs. Specifically, the increasing demand for aseptic processing of toxic compounds represents the most challenging scenario in isolation technology. In aseptic processing, all the focus is on the protection of the product (positive pressure, usually also laminar airflow), while in containment applications the goal is to protect the operator from the product (negative pressure, turbulent airflow). When both these requirements are present, the two opposing philosophies have to be balanced, providing a cost-effective and safe solution for both the operator and the product.