Eye drops constitute a dosage form of medications for use on the eye. As preparations on an aqueous or oily basis, these are applied directly to the eye, in order to enable the local effect of the medicinal substances contained in the preparation. Various regulations are to be observed and adhered to in the production of eye drops. Sterile preparation of these medications is a basic prerequisite. For this reason, the mixing plants must be designed for pressure and vacuum-proof sterile production to ensure industrial production of eye drops and other pharmaceuticals in accordance with GMP.
In order to prevent irritation of the eye, eye drops should also have a certain pH-value. This is to be set as close as possible to the physiological pH-value of 7.4. At a pH of this value, however, most active substances are chemically unstable. For this reason, the production of eye drops should achieve optimal stability of the active ingredients, without impairing the pH or the osmotic pressure of the medication. The process plants should have various installation options available in the homogenising chamber to enable monitoring of the pH-value, temperature, flow rate, etc., as well as further installation options for the pH-value in the re-circulation line, for example.
The cleaning system (CIP) is usually attached to the lid and/or the agitator. This must be able to provide dead-space-free, uncomplicated and process time-reducing cleaning.
Sterilisation of the plants (SIP), is also a basic pre-requisite for absolute freedom from germs in the containers, pipelines and valves.