Facility Monitoring (FMS) Archives

Case Study: Isolator Contamination Control at AST

Learn how AST uses PMS instruments for isolator contamination control.

Since 1965, AST has been delivering innovative solutions – many of which were industry firsts and have since become industry standards. AST has always understood that our customers serve demanding and oftentimes unpredictable markets. We also understand that “flexibility is the antidote to uncertainty,” and as your partner, AST consistently seeks to deliver innovative solutions that are robust, yet flexible.

Cleanroom Validation and Qualification Approach in Annex 1 2022

With the inclusion of cleanroom validation and qualification in the flexible and scientifically sound pharmaceutical processes proposed by the new Annex 1 revision, an overall review of pharmaceutical development is essential. The aim of pharmaceutical development is to design a quality product and a manufacturing process to consistently deliver the intended performance of the final product.

ISO 14644-2:2015 Cleanroom Monitoring Frequently Asked Questions

Thisquestions and answers paper is a follow up to the webinar, “ISO 14644-2:2015 Cleanroom Monitoring”. Many questions were asked about cleanroom practices and the most recent to the ISO standard. Questions submitted during and after the webinar are answered below.

contamination control strategy for a fill line

Contamination Control Strategy (CCS) Considerations and Steps

Mass-produced pharmaceuticals have come far since the industrial manufacturing of synthetic drugs at the end of the 19th century with rapid advancement in technology, process control, and sterility requirements. Yet even as improvements to Pharma develop, recalls still occur with regularity and their significant impact on both the manufacturer and consumer are why worldwide regulation of the industry is so enforced. Environmental monitoring (EM) is one facet of the greater picture of current good manufacturing practices (cGMPs) that has been standardized for the safety of human health.