Managing disinfection within an advanced CCS


“Managing disinfection within an advanced CCS”
14-15 marzo 2024
Sede: AM Instruments Via Isonzo, 1/c, 20812 Limbiate MB

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Among the new elements introduced by the revision of Annex 1, a particularly important role is played by the Contamination Control Strategy (CCS), a mandatory, integrated approach to identify, assess and manage contamination risks that could affect the quality and safety of sterile products.

In the context of CCS, cleaning and disinfection are key elements for which Annex 1 establishes precise criteria that emphasise risk assessment and mitigation based on understanding the production process of sterile products. The ultimate goal is to create a specific disinfection and monitoring programme approved by Quality Assurance to ensure the required compliance.

The event organised by PDA Italy Chapter in AM Instruments headquarter under the patronage of AFI is dedicated to the application of these criteria: a two-day event dedicated to discussions with major experts in the field and the analysis of various case studies, such as glove management and
materials handling , cleaning, sanitizing agents, disinfectants evaluation, materials
compatibility, and frequency program and sanitization technologies.

In this video, Francesco Boschi, coordinator of AFI’s Microbiology Group and member of the event’s organising committee, explains the contents.

Given that the revision involves more than 100 requirements, it is inevitable that many issues remain to be resolved, for example, section 8.123, dedicated to lyophilization, which will come into effect on August 25th of this year, as explained by Lucia Ceresa, PDA Italy Chapter Steering.