IEST: contamination control guidelines

Not directly related to pharmaceuticals, but possible of wider interest those involved with controlled environments.

The Institute of Environmental Sciences and Technology (IEST) has released a new Recommended Practice, IEST-RP-CC046.1: Controlled Environments (Aerospace, Non-cleanroom), which contains contamination control guidelines from piece-part acquisition to product delivery.

The guideline contains contamination control criteria to support successful performance of high-reliability products and associated subassemblies, which are not required to be produced in cleanrooms. A key factor in protecting such products from contamination is the development of a Contamination and Foreign Object Damage (FOD) Control Program.

This first-edition Recommended Practice is focused on the aerospace industry and provides a minimum set of requirements for a basic contamination control programme, which could be tailored to specific products and processes.

“This Recommended Practice provides a set of basic guidelines for producing high-reliability products using affordable methods to control production environments and prevent contamination,” said Rick George, Chairman of the IEST Working Group that produced this document. “These guidelines, which have been sorely lacking in many industries, make it easier for smaller companies to provide clean products in a cost-effective manner.”

Using a “clean as you go” approach, IEST-RP-CC046.1 sets out standardised procedures to mitigate contamination during production operations and preserve product cleanliness through assembly, test, storage, and transportation.

The goals of this approach are to: prevent intrusion of contaminants from outside the controlled area; minimise the generation of contaminants within the controlled area; and remove contaminants before they can attach to critical surfaces.

For further details see IEST

Posted by Tim Sandle