Vaccine production requires the highest precision. Unlike other pharmaceutical products, vaccines can contain biological substances and, in certain cases, even live pathogens.
Special production requirements
Vaccines require much 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 requirements. The following aspects are particularly important:
- precise scale-up from laboratory scale to the production plant thanks to identical design and performance of the agitation and homogenising machines
- consistently high product quality in every plant size
- aseptic valves and GMP-compliant plant design
- integrated cleaning systems (CIP) for dead-space-free cleaning
- sterile sterilisation of the plant (SIP)
Control and documentation
Precise documentation of all production steps by powerful software is also of great importance. Modern process plants offer suitable solutions – from a small recipe control with a separate recorder to a large 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 via a central control system.
FAQ: Process plants for vaccine production
What matters most in vaccine production?
Vaccines contain biological substances, sometimes live or inactivated pathogens. Sterility, aseptic processing, gentle handling, complete documentation and extensive quality control are essential.
What role do agitation and homogenising machines play?
They are used for formulation, mixing with adjuvants and emulsification. Gentle energy input, aseptic valves, GMP design and CIP/SIP capability are key.
How is scale-up from lab to production achieved?
With laboratory, pilot and production machines of identical design and performance layout, so that process parameters can be transferred directly.
Why is process documentation so important?
Batch release requires every production and cleaning step to be traceable. Modern controls with recipe management and audit trail record all data automatically.
Does SEEFRIED support vaccine production projects?
Yes, with process plant design, qualification (DQ/IQ/OQ/PQ) and suitable agitation and homogenising equipment.