Fill & Finish – Applicative module

This activity immerses the user in the complete execution of an aseptic formulation, including thawing, weighing, mixing, filtration, and temporary storage.It also includes sampling (pH, bioburden, sterility, osmolality) to verify product compliance, while strictly following the procedures outlined in the batch record.

This immersive activity allows the user to simulate the setup of the equipment required for filling in an isolator: checking the materials according to the batch record, setting up environmental monitoring (agar plates, particle counter), supplying vials, stoppers, caps, and needles, and then starting production.The user is responsible for following the batch record, initiating production in compliance with critical parameters, and performing the final reconciliation.

This interactive activity provides training in the final visual inspection of filled containers (vials or syringes).