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
In the pharmaceutical industry, cleaning processes are vital, especially when dealing with equipment that cannot be effectively cleaned without disassembly. This is where the Clean-Out-of-Place (COP) method becomes essential. COP involves removing and disassembling equipment parts, which are then cleaned...
- 19 August 2024
- 2 Min Read
𝗖𝗹𝗲𝗮𝗻-𝗶𝗻-𝗣𝗹𝗮𝗰𝗲 (𝗖𝗜𝗣) is a fundamental cleaning method used in pharmaceutical manufacturing to ensure equipment is cleaned without the need for disassembly. This process is vital for maintaining hygiene, preventing cross-contamination, and ensuring that pharmaceutical products meet stringent safety and quality...
- 9 August 2024
- 2 Min Read
Cleaning validation is a cornerstone of maintaining pharmaceutical safety and product integrity, especially with the updated guidelines in Annex 1 of the EU GMP. The revised Annex 1 emphasizes the need for robust contamination control strategies to prevent microbial, particulate,...
- 4 July 2024
- 2 Min Read
EMA Unveils Revised Annex 1 in Pharmaceutical Regulation The final version of the EMA revised Annex 1, a monumental achievement in pharmaceutical regulation, was unveiled on August 25, 2022, marking the culmination of a seven-year revision process. The comprehensive changes...
- 21 June 2024
- 2 Min Read
The pharmaceutical industry is continuously evolving, with innovations and advancements emerging at a rapid pace. One of the critical areas that has seen significant development recently is cleaning validation. Ensuring that manufacturing processes are free from contaminants is essential for...
- 19 June 2024
- 3 Min Read
The recent updates to the EU GMP Annex 1 shed light on the critical considerations surrounding lyophilization in sterile manufacturing. Lyophilization, often seen as an extension of aseptic processing, introduces unique challenges due to its intricate processes and sensitive product...
- 14 June 2024
- 2 Min Read
Considering that container performance is the primary trait protecting product safety until the point of use, it will continue to receive increasing regulatory attention in the sterile manufacturing space. The updates to Annex 1 align with the regulatory shifts experienced...
- 7 March 2024
- 2 Min Read
