Critical Process Parameters in Sterilization: Steam Requirements According to EU GMP Annex 1

EU GMP Annex 1: What is it?

The EU GMP Annex 1 sets out guidelines for the production of sterile medicinal products. The 2022 version of the Annex, which updates the 2008 version, is crucial for ensuring compliance with regulatory changes related to production and the environment, as well as for maintaining high quality standards in the manufacture of sterile medicinal products.

Updates in the requirements for the creation of sterile medicinal products helped to provide a better understanding of the risk management process. Though, parameters as well as new technological developments are essential to the manufacturing industry.  

Steam requirements according to EU GMP Annex 1

Roberto Español, Pharma Technical Manager for Trescal Spain, presented a poster at the 2023 International Metrology Congress (CIM) on the critical process parameters in sterilization specific to steam requirements.