Prague will host the 2nd Cleaning Process & Validation Conference on 19–20 November 2025, as regulators and manufacturers intensify their focus on contamination control in pharmaceutical production. The event comes at a time when cleaning validation has moved from a...
- 18 September 2025
- 2 Min Read
The 2022 revision of EU GMP Annex 1 has introduced more stringent expectations for contamination control in sterile manufacturing, with direct implications for cleaning processes and their validation. One of the key changes is the requirement to validate the entire...
- 22 May 2025
- 2 Min Read
​In December 2024, a critical incident emerged in central Mexico involving contaminated intravenous (IV) feeding bags, leading to the tragic deaths of 17 children, primarily underweight, premature infants, and a 14-year-old patient. The contamination was traced to a manufacturing plant...
- 14 March 2025
- 2 Min Read
The pharmaceutical industry relies on robust cleaning processes and validation to ensure product quality and patient safety. ASTM International, a global standards organization, provides essential guidance that supports this critical area. “Clean systems, cleaner outcomes—ASTM standards make it possible.” ASTM...
- 11 January 2025
- 1 Min Read
The cleanroom sector is undergoing transformative changes, driven by technological advancements and evolving regulatory standards. These trends are revolutionizing how cleanrooms operate, focusing on efficiency, contamination control, and sustainability. 1. Advanced Automation and Robotics Automation is playing an increasingly vital...
- 15 October 2024
- 2 Min Read
Cleaning validation is a vital process in the pharmaceutical industry to ensure the safety, quality, and efficacy of drug products. It involves validating that the cleaning processes applied to manufacturing equipment consistently remove product residues, contaminants, and cleaning agents to...
- 10 September 2024
- 2 Min Read
