In the industrial manufacture of injection solutions, solid and liquid substances are frequently mixed to form a solution for direct use. The active ingredients are often in powder form, while the other substances are usually liquid.
Requirements for the homogenising mixer
Modern homogenising mixers must enable sterile production and fast manufacturing. They also need optimum options for controlling and monitoring the processes, as well as precise documentation of all production steps.
- Pressure- and vacuum-resistant design
- Installation options for additional measuring units, e.g. particle size measurement
- Production according to complex recipe specifications
- Aseptic valves and fittings and GMP-compliant design
Freedom from suspended particles and product quality
The number of airborne particles must be kept as low as possible, because only a solution free of suspended particles can be filtered down to a certain particle size – and this is a prerequisite for high-quality injection solutions.
With identical design and performance rating of laboratory and production machines, precise scale-up with consistently high product quality is also achieved. Thanks to aseptic valves and fittings and GMP-compliant design, homogenising mixers can be used flexibly for almost all pharmaceuticals – from liquid to semi-solid.
FAQ: Manufacturing injection solutions
How are injection solutions manufactured?
Powdered active ingredients are dissolved in liquid carriers, the solution is adjusted, sterile-filtered or produced aseptically and filled into ampoules, vials or syringes.
Which mixer is suitable for injection solutions?
Pressure- and vacuum-resistant homogenising mixers in GMP design with aseptic valves and fittings, powder induction under vacuum and connection options for measuring equipment.
Why is freedom from particles so important?
Particles in parenterals are a safety risk. In-process measurement and sterile filtration ensure that the limit values are complied with.
How is reliable scale-up achieved?
With laboratory and production machines of the same design and performance rating, so that recipes and parameters can be transferred directly.
Does SEEFRIED supply plants for parenterals?
Yes, we design and qualify plants for injection and infusion solutions and offer suitable homogenising mixers.