The manufacture of vaccines requires the highest precision. Vaccines differ from other pharmaceutical products in that they can contain biological substances and, in certain cases, even live pathogens.
Special requirements for production
Vaccines require significantly longer production cycles. In addition, extremely strict safety and quality criteria apply, and quality controls take up a large part of the total production time. The specific nature of the components makes production even more difficult.
Requirements for the process plant
The machines used must therefore meet all production-relevant aspects. The following are particularly important:
- Precise scale-up from laboratory scale to production plant through identical design and performance rating of the agitating and homogenising machines
- Consistently high product quality in every plant size
- Aseptic valves and fittings and GMP-compliant plant design
- Integrated cleaning systems (CIP) for dead-space-free cleaning
- Germ-free sterilisation of the plant (SIP)
Control and documentation
Also of great importance is the precise documentation of all production steps by means of powerful software. Modern process plants offer suitable solutions for this – 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 and continuous documentation in the background. In addition, the plant can be operated from a central control system station.
FAQ: Plants for vaccine manufacturing
What is particularly important in vaccine manufacturing?
Vaccines contain biological substances, in some cases live or inactivated pathogens. Sterility, aseptic processing, gentle process control, complete documentation and extensive quality controls are crucial.
What role do agitating and homogenising machines play?
They are used, for example, in formulation, mixing with adjuvants and emulsifying. Gentle energy input, aseptic valves and fittings, GMP design as well as CIP and SIP are important.
How is scale-up from the laboratory to production achieved?
Through laboratory, pilot and production machines with identical design and the same performance rating. This allows process parameters to be transferred directly.
Why is process documentation so important?
For batch release, all production and cleaning steps must be traceable. Modern control systems with recipe management and audit trail record all data automatically.
Does SEEFRIED support projects in vaccine production?
Yes, with process plant planning, qualification (DQ/IQ/OQ/PQ) and suitable agitating and homogenising plants.