In the manufacture of pharmaceuticals special regulations and extremely strict requirements apply. In the industrial production of eye ointments, freedom from suspended particles is an additional requirement.
Requirements for the process plant
Process plants for eye ointments should be powerful and flexible. In addition, it should be possible to install a particle size measurement system, for example in the homogeniser chamber.
This measurement plays a decisive role, as it is the only way to monitor 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 on the agitator for dead-space-free cleaning
- Compliance with all mechanical engineering and hygiene regulations
Frequently asked questions about manufacturing eye ointments
What is particularly important when manufacturing eye ointments?
In addition to strict pharmaceutical regulations, above all freedom from suspended particles: large particles would cause mechanical irritation in the eye. It should therefore be possible to measure particle size, e.g. in the homogeniser chamber.
What requirements apply to the process plant?
It should be powerful and flexible, offer CIP cleaning with rotating cleaning devices in the lid and on the agitator, and be SIP-capable with a GMP-compliant, dead-space-free design.
Why is particle size measurement so important?
It is the only way to continuously monitor product quality and ensure that the finished product contains no oversized particles.
Do you provide support with the design of such plants?
Yes. We advise on the design, equipment and qualification of homogenising plants for eye ointments and other sterile pharmaceuticals.