The day dedicated to those who face the challenges of cleaning and disinfection in contamination-controlled environments every day.
Case Study: Contamination control assessment cleaning and disinfection
This presentation explores the principles of Contamination Control Strategy (CCS) in the pharmaceutical industry, with a focus on cleaning and disinfection processes. Key elements such as microbial and particulate contamination and ensuring sterility are covered: a case study related to residue management and material transfer processes in a sterile pharmaceutical production, emphasizing protective measures and effective disinfection techniques.
Considering the revised version ofEudraLex Annex 1 Volume 4, published in August 2022, residue management has gained more importance, with references in four different sections of the document.
Specifically, under "Disinfection," Section 4.33 states, "Cleaning programs should effectively remove disinfectant residues."
This presentation demonstrates how visual inspection (visual inspection) alone may not be sufficient for proper residue management and introduces an analytical method published by Ecolab for detecting disinfectant residues on a surface and its application for verifying the effectiveness of rinsing techniques.
A practical demonstration on the importance of using the correct packaging cleaning technique through the proper use of wipes during the material transfer process, respecting class jumps; here, effective methods for removing contamination from packaging are examined.
Fungal and yeast contamination in contamination-controlled environments can pose a significant challenge to drug manufacturing, as it carries the risk of compromising the quality of the finished product and patient safety. Understanding its complexity, including the major strains of interest, is essential to implement effective control measures.
This presentation discusses the morphology of fungi and yeasts, the possible sources of contamination, the risks and challenges they pose, and the need to structure a system of preventive and corrective actions (CAPA plan) that can avoid problems of regulatory noncompliance.
Participation is free of charge and is subject to preregistration and confirmation by AM, which reserves the right to limit or cancel registrations based on seat availability.
Applications will be accepted on a first-come, first-served basis, subject to availability.
The reports will be in English.
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