Infusion solutions are manufactured in a multi-stage process that combines in-depth product knowledge with the highest precision. Since infusion therapy is used in many medical fields, infusion solutions vary greatly in composition and active ingredients.
The highest demands on production
Infusions deliver important medicines, nutrients or other substances. In doing so, they support the healing process and can even be life-saving. Infusion solutions must therefore be manufactured extremely precisely, conscientiously and under strict safety and quality criteria.
This requires gentle stirring as well as accurate heating and cooling with minimal tolerances. In addition, the production sequence consists of several steps that must interlock quickly and as seamlessly as possible.
Requirements for the process plant
Agitating and homogenising machines are suitable for this not only because of their performance and flexibility. The following are also important:
- Option to install a particle size measurement system in the homogeniser chamber
- GMP-compliant plant design and, on request, aseptic valves and fittings for sterile manufacturing
- Precise scale-up from laboratory scale to production plant through identical design and performance rating
Particle size measurement plays a decisive role, as it is the only way to monitor and minimise the number of airborne particles. This freedom from suspended particles is a prerequisite for being able to filter particles down to a size of 0.2 micrometres out of the solution.
Weighing and recipe management
Before batching, the required raw materials – for example glucose or common salt – are weighed according to order and recipe. A sophisticated control system with recipe management, manufacturing and batch records as well as archiving and raw material management helps here.
FAQ: Manufacturing infusion solutions
How are infusion solutions manufactured?
Raw materials such as glucose or sodium chloride are weighed exactly according to the recipe, dissolved in water for injection (WFI), adjusted, sterile-filtered (0.2 µm), filled and usually terminally sterilised.
What requirements apply to the plant?
GMP-compliant design, aseptic valves and fittings, gentle stirring, precise heating and cooling with tight tolerances, and CIP and SIP capability.
Why is particle control important?
Parenterals must be largely free of particles. In-process particle measurement and sterile filtration ensure this.
What role does the control system play?
Recipe management, manufacturing and batch records, raw material management and archiving ensure reproducibility and traceability.
Does SEEFRIED offer plants for infusion solutions?
Yes. We design and qualify batching plants for infusion and injection solutions and supply suitable agitating and homogenising technology.