Special regulations and extremely strict requirements apply to the production of pharmaceuticals. In the industrial production of eye ointments, freedom from suspended particles is also essential.
Requirements for the process plant
Process plants for eye ointments should be efficient and flexible. In addition, it should be possible to install a particle size measurement, for example in the homogeniser chamber.
This measurement plays a crucial role, because it is the only way to control and assure product quality. The number of airborne particles must be kept as low as possible. This freedom from suspended particles prevents large particles in the eye, which could otherwise cause mechanical irritation.
Hygiene and cleaning
Protecting fragile cell cultures and consistent quality assurance are important prerequisites for high-quality eye ointments. Pharmaceuticals are also highly sensitive. The CIP cleaning process and the SIP-capable machine design must therefore ensure compliance with all hygiene regulations:
- rotating CIP cleaning system in the lid (GMP-compliant design)
- additional cleaning at the agitator for dead-space-free cleaning
- compliance with all mechanical engineering and hygiene regulations
FAQ: Producing eye ointments
What are the key requirements for producing eye ointments?
Eye ointments must be sterile and free of coarse particles. The process plant has to be GMP-compliant, CIP/SIP capable and allow controlled homogenisation, ideally with in-line particle size monitoring.
Why is particle size so important for eye ointments?
Large particles can cause mechanical irritation of the eye. A defined, fine particle size distribution is therefore a critical quality attribute and should be measured during production, e.g. in the homogeniser chamber.
Which machine is suitable for eye ointment production?
Vacuum homogenising mixers with a scraper agitator, in-line or bottom homogeniser and sterile design (pressure and vacuum rated) are the standard choice for ointment bases with suspended active ingredients.
How are plants for eye ointments cleaned?
By CIP spray devices in the lid and on the agitator for dead-space-free cleaning, followed by SIP sterilisation with saturated steam.
Does SEEFRIED supply equipment for eye ointment production?
Yes. SEEFRIED Verfahrenstechnik plans process plants for pharmaceutical semi-solids and supplies inspected used homogenising mixers. Contact us for a suitable machine or a feasibility check.