The production of nose drops requires scientific knowledge and precise production processes. As nose drops, in contrast to many other pharmaceutical products, are aqueous substances that are mixed with other phases, they require special production cycles. Extremely stringent safety and quality criteria must also be adhered to in pharmaceutical production. Quality controls occupy a large proportion of the total production time. The specific nature of the constituents of nose drops further complicates production.
In order to meet the numerous provisions for the production of nose drops, the agitator and production plants must be able to fulfill all production-relevant aspects. Identical design and performance layout must be selected for Scaling-Up processes, in order to guarantee fast and precise reation, whilst maintaining consistently high product quality, from lab scale to process plant.
This means that the nose drop production can run precisely and without quality deviation. Aseptic construction of fittings and GMP design, as well as an integrated Cleaning-In-Place (CIP) design, must guarantee compliance with the hygiene regulations. Also of great importance in the production of nose drops is the most precise documentation of the production steps. From a small recipe control with separate recorder for documentation, to a large visualisation on a touch-panel with specially designed operating panel, integrated recipe sequence for production and cleaning steps, ongoing documentation of all processes running in the background, as well as operation of the systems by means of a central control unit, a specially tailor-made program is to be developed for each customer.