Infusion solutions are produced in a multi-stage process that combines detailed product knowledge with the highest precision. Because infusion therapy is used in many medical fields, infusion solutions differ greatly in composition and active ingredients.
Highest production requirements
Infusions supply important medicines, nutrients or other substances. They support the healing process and can even save lives. Infusion solutions must therefore be produced extremely precisely, conscientiously and in compliance with strict safety and quality criteria.
Gentle agitation and accurate heating and cooling with minimal tolerances are essential. In addition, production consists of several steps that must interlock quickly and as seamlessly as possible.
Requirements for the process plant
Agitation and homogenising machines are suitable not only because of their performance and flexibility. The following features are also important:
- option to install a particle size measurement in the homogeniser chamber
- GMP-compliant plant design and aseptic valves on request for sterile production
- precise scale-up from laboratory scale to the production plant thanks to identical design and performance
Particle size measurement plays a crucial role, because it is the only way to control and minimise the number of airborne particles. This freedom from suspended particles is the prerequisite for filtering particles down to a size of 0.2 micrometres out of the solution.
Weighing and recipe management
Before the solutions are prepared, the required raw materials – such as glucose or sodium chloride – are weighed according to order and recipe. A sophisticated control system with recipe management, production and batch records, archiving and raw material management is very helpful here.
FAQ: Producing infusion solutions
How are infusion solutions produced?
Raw materials such as glucose or sodium chloride are weighed according to recipe, dissolved in water for injection (WFI), adjusted, sterile-filtered (0.2 µm), filled and usually terminally sterilised.
What are the requirements for the plant?
GMP-compliant design, aseptic valves, gentle agitation, precise heating and cooling with tight tolerances and CIP/SIP capability.
Why is particle control important?
Parenteral products must be practically free of particles. In-process particle measurement and sterile filtration ensure this.
What role does the control system play?
Recipe management, batch records, raw material management and archiving ensure reproducibility and traceability.
Does SEEFRIED offer plants for infusion solutions?
Yes. We plan and qualify compounding plants for infusion and injection solutions and supply suitable agitation and homogenising equipment.