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.
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FAQ: Producing eye drops
How are eye drops produced industrially?
Eye drops are aqueous or oily solutions or suspensions that are mixed, adjusted for pH and osmolality, sterile-filtered or terminally sterilised and filled under aseptic conditions in GMP-compliant plants.
Which pH value should eye drops have?
As close as possible to the physiological tear fluid pH of about 7.4. Because many active substances are less stable at this pH, formulation and process must balance stability, pH and tonicity.
Which measurements are needed in the process plant?
Typically pH, temperature, flow rate and pressure, with sensors in the homogenising chamber or in the recirculation line.
Why are CIP and SIP essential for eye drop production?
Eye drops must be sterile. CIP removes product residues without dead spaces, SIP sterilises vessels, pipework and valves with steam.
Can SEEFRIED help with an eye drop production plant?
Yes. We plan sterile process plants and supply suitable used mixing and homogenising equipment for pharmaceutical liquids.