Behaviors in DSP in cGMPs and Industrial Environment

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This activity reviews the contamination risks associated with controlled environments in bioproduction and details the specific requirements for classified areas according to European and ISO standards. It introduces collective protective equipment such as laminar flow hoods and biosafety cabinets (BSCs), along with best practices for gowning, hygiene, and behavior in DSP areas.

This activity simulates sensitive DSP operations such as additive additions or open sampling, analyzing the associated risks and their potential impact on product quality. It develops proper response reflexes in the event of an incident, emphasizes traceability rules in the batch record, and guides the implementation of corrective and preventive actions (CAPA).

This activity illustrates the expected behaviors before, during, and after an intervention in a clearoom, using real-life field scenarios.