Eye drops are a dosage form of medicinal products for use in the eye. As oil-based or aqueous preparations, they enable the local effect of the active ingredients they contain.
Sterile production as a basic requirement
Numerous regulations apply to the production of eye drops, and sterile production is a basic requirement. The mixing plants must therefore be designed for pressure- and vacuum-resistant sterile production. This is the only way to produce eye drops and other pharmaceuticals industrially in accordance with GMP.
pH value and stability of the active ingredients
To prevent irritation of the eye, eye drops should have a pH value as close as possible to the physiological value of 7.4. At this pH value, however, most active ingredients are chemically unstable.
Production must therefore achieve optimal stability of the active ingredients without affecting the pH value or the osmotic pressure of the medicine. For this purpose, the process plant should offer the following equipment:
- installation options in the homogeniser chamber for monitoring pH value, pressure, temperature and flow
- additional measuring points, e.g. for the pH value in the circulation line
Cleaning and sterilisation
The cleaning system (CIP) is usually attached to the lid and/or the agitator. It must enable dead-space-free, straightforward and time-saving cleaning. Likewise, sterilisation of the plant (SIP) is a basic requirement for absolute sterility in vessels, lines and valves.
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.