Understanding the critical components of a successful cleanroom and barrier isolator project

Abstract

The critical components of cleanroom and barrier isolator systems are described. Cleanroom and barrier isolator systems have four basic parts: the physical structure, the internal environment, the interaction technology, and the monitoring system. To create an aseptic environment, pharmacists must understand each of these components and be able to provide vendors with clear specifications. Among the decisions pharmacists must make are what materials should be used in construction, how many filters to use and where these should be placed, how to best reduce the contamination challenge to the area, and the best means of monitoring the room's air cleanliness. Evaluation of each component should be made on the basis of durability, functionality, and cost. Pharmacists must also have a set of criteria to help them choose a vendor. They must know their state's requirements and ensure that whatever system is built for their organization will meet all regulations. Cleanroom and barrier isolator systems must adhere to Federal Standard 209E, which defines standard classes of air cleanliness that are based on specific concentrations and sizes of airborne particles. Having an understanding of the basic components of cleanroom and barrier isolator systems will help pharmacists define their needs and describe them to vendors.