Fluids must be added to a substance mixture in pharmaceutical processes. This can also mean that the system must first prepare the product to be conveyed (e.g., blending, melting of salts, temperature control, dispersing, etc.). A custom-designed solution for the functionality of the system and adjustment of the individual components to the overall system is therefore required.
The actual conveying of the fluid must then be done under defined process conditions, e.g., definition of pressure and temperature, placing high demands on process control and thus on the complete system solution.
A stable process is possible with coordinated and individually programmed instrumentation and control technology and a control system. Using storable recipes in this system control, processes are carried out reliably and with maximum repeatability. Logging of the process progress and its results is indispensable for a reliable production in order to fullfil cGMP requirements.
The different user levels are only accessible to approved users. The system must have a design concept so that these can be qualified and validated. Therefored the guidelines according to CFR 21 part 11 are fulfilled.
The product made with the system must correspond to the specified quality guidelines of the pharmaceutical industry and conformity must be able to be verified at anytime.