EU ANNEX-1 And The Impact Of Contamination Control Strategy On Cleaning & Disinfection

Recent contamination incidents in the pharmaceutical industry highlight the critical need for robust contamination control. The newly revised EU Annex 1 regulations emphasize the importance of a Contamination Control Strategy (CCS) to minimize risks associated with microbial, particulate, and endotoxin/pyrogen contamination.

This article delves into the impact of CCS on cleaning and disinfection practices within cleanrooms. We'll explore key considerations outlined in the revised EU Annex 1, such as:

Prioritizing cleaning: Effective cleaning to remove surface contaminants is essential before disinfection.

Disinfectant validation: Rigorous validation studies ensure disinfectants are effective in the specific conditions used.

Risk-based approach: Cleaning and disinfection programs should be tailored to address identified contamination risks.

Following these guidelines can significantly reduce the risk of contamination and ensure the production of high-quality sterile drugs. Learn more about the revised EU Annex 1 regulations and how to ensure your cleaning and disinfection practices meet the latest standards.