The manufacture of nasal drops requires scientific knowledge and precise production processes. Unlike many other pharmaceutical products nasal drops are aqueous substances that are mixed with further phases.
Special requirements for production
Nasal drops require special production cycles. In addition, extremely strict safety and quality criteria apply in pharmaceutical manufacturing, and quality controls take up most of the production time. The specific nature of the components makes manufacturing even more difficult.
Requirements for the agitating and homogenising plant
For production to run precisely and without quality deviations, the plant must meet all production-relevant aspects:
- Identical design and performance rating for precise scale-up from laboratory scale to process plant
- Consistently high product quality with fast, precise process control
- Aseptic valves and fittings and GMP-compliant design
- Integrated cleaning-in-place (CIP) for sterile manufacturing and hygiene
Control and documentation
Also of great importance is the precise documentation of all production steps. Solutions range from a small recipe control with a separate recorder to large-scale visualisation on a touch panel.
Large solutions include an integrated recipe sequence for production and cleaning steps, continuous documentation in the background and operation via a central control system. This results in the right program for every customer.
FAQ: Manufacturing nasal drops
How are nasal drops manufactured?
Active ingredients are dissolved in an aqueous base, buffers, tonicity agents and, where necessary, preservatives are added, the pH value is adjusted, and the product is filtered and filled under low-germ or sterile conditions.
What requirements apply to the process plant?
Aseptic valves and fittings, GMP design, CIP cleaning without dead spaces, SIP capability and precise measurement and control technology for pH value and temperature.
How is scale-up achieved?
Through laboratory and production plants with identical construction and performance rating. This keeps product quality the same from trial to production.
Why is documentation so important?
For GMP-compliant batch release, all production and cleaning steps are recorded automatically, from simple recipe control to a process control system.
Does SEEFRIED support plants for nasal drops?
Yes, with planning, qualification and suitable agitating and homogenising plants for liquid pharmaceuticals.