Annex 1 2022 v. Annex 1 2008
Annex 1 2008 is the basis for the 2022 version. This paper provides an easy-to-understand side by side comparison of the Annex 1 2008 v. 2022 versions, broken down by section.
Archives: Papers
Alarm Rationale for Continuous Particle Counting Systems
Alarm rationale is a critical component when designing your cleanroom environmental monitoring system. Understand the factors and considerations.
Understanding Nanoparticle Contamination in Ultrapure Water (UPW) Systems
Semiconductor industry leaders have emphasized the importance of understanding nanoparticle contamination in ultrapure water (UPW) production and distribution. They have explored the advantage of monitoring particle baseline at 20 nm over the existing 50 nm particle performance of the state-of-art UPW system. Many interesting investigations on this space pivot around the motivations to study the value of monitoring particle size down to 20 nm at the UPW system.
New Challenges in Data Integrity: Are You Ready for the Data Quality Era?
The role of quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other specialized functions. Creating a deeper quality connection between manufacturing and engineering has always been the aim of that growth.