Eye drops are a dosage form of medicinal products for application to the eye. As oil-based or aqueous preparations, they enable the local action of the drugs they contain.
Sterile manufacturing as a basic prerequisite
Numerous regulations must be observed in the production of eye drops, and sterile manufacturing is a basic prerequisite. The mixing plants must therefore be designed for pressure- and vacuum-resistant sterile production. This is the only way to achieve the industrial manufacture of eye drops and other pharmaceuticals in line 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.
Manufacturing must therefore achieve optimum stability of the active ingredients without affecting the pH value or the osmotic pressure of the medicinal product. For this, the process plant should offer the following equipment:
- Installation options in the homogeniser chamber for monitoring pH value, pressure, temperature and flow rate
- Additional measuring points, e.g. for the pH value in the circulation line
Cleaning and sterilisation
The cleaning system (CIP) is usually mounted on the lid and/or the agitator. It must allow dead-space-free, straightforward and time-saving cleaning. Likewise, sterilisation of the plant (SIP) is a basic prerequisite for absolute sterility in vessels, pipework and valves.
Frequently asked questions about manufacturing eye drops
What is a basic prerequisite for manufacturing eye drops?
Sterile manufacturing. The mixing plants must therefore be pressure- and vacuum-resistant and designed for GMP-compliant sterile production, including CIP cleaning and SIP sterilisation.
What pH value should eye drops have?
As close as possible to the physiological pH value of 7.4 to avoid irritation. Since many active ingredients are unstable at this value, manufacturing must achieve stability without affecting the pH value and osmotic pressure.
What measuring equipment does the plant need?
Installation options for monitoring pH value, pressure, temperature and flow rate, e.g. in the homogeniser chamber or in the circulation line.
How are the plants cleaned?
Via a CIP system on the lid and/or agitator that cleans without dead spaces and saves process time, plus SIP sterilisation for absolute sterility of vessels, pipework and valves.