Kaye Solutions for Fermenter
Fermentation Technology/Bioreactors
Bioreactors, often referred to as fermenters, are crucial for the fermentation of organic substances in the food, pharmaceutical, and cosmetics industries. They have been used for centuries, for example, in food production for creating sauerkraut or in the pharmaceutical industry for producing penicillin.
Fermenters enable the safe cultivation of cells, bacteria, and other microorganisms, both in laboratories and production facilities. These processes are highly sensitive and require precise monitoring of all critical parameters such as temperature and pressure, especially under aseptic conditions, for example, in the production of insulin or vaccine precursors.
Structure and Function of Fermenters
Fermenters or bioreactors are generally made of stainless-steel tanks available in various sizes, from small laboratory fermenters to bioreactors with several thousand-liter capacities. Critical measurements and peripheral systems must be taken into account both during operation and validation. These include:
- Temperature
- Pressure
- pH Level
- Mixing Systems
- Heat Exchangers
- Sterile Filters
- Gassing Systems
- Fill Level
- Oxygen Supply
- Nutrient Supply
- and others
Procedures such as CIP (Cleaning in Place) and SIP (Sterilization in Place) require significant validation efforts, particularly for fixed installations. Validation requirements must be considered during the design phase (DQ) with appropriate validation ports to prevent complications during GxP-compliant commissioning (IQ/OQ/PQ).
The Kaye AVS and ValProbe RT validation systems are ideal for the checking and validation of fermenters and bioreactors in aseptic environments and under GMP considerations. For more information on our products and solutions, please visit our website. We are pleased to support you with customized solutions for your specific requirements in the pharmaceutical and biotechnology industries.