Fermenters and Bio-Reactors

Introduction

Fermentation is the biochemical synthesis of organic compounds by microorganisms. The process of growing microorganisms within an enclosed tank (fermenter) under controlled conditions of aeration, agitation, temperature, and pH.

The kinetics of any fermentation, which may be measured by growth and product formation profiles, can be affected by a range of biochemical and physicochemical determinants. These include the process strain, the innoculum development regime, medium composition, medium pH, nutrient concentration and temperature.

Approach

Our testing is comprehensive and designed to satisfy the requirements of US (FDA), UK (MHRA) and European regulatory authorities.

We perform thermometric and micro biological challenge testing to confirm the efficiency of the sterilisation process.

We temperature map the filled fermenter across the range of operation to confirm the required conditions of temperature and uniformity are maintained.

We perform coverage tests to determine the efficiency of the cleaning process.

Detailed validation reports are compiled that contain all of the real-time data generated as well as a concise summary and clear conclusion.

Experience

We are experienced in fermentation technology and all aspects of fermentation vessel and bioreactor validation,ranging from stirred-tank reactors to gas-lift fermenters,

We have extensive experience in engineering studies that include mixing and scale up studies using various tools such as mathematical modelling and oxygen transfer coefficient (KLA) studies.

We can help with the generation of User Requirement Specifications (URS), perform Design Qualification (DQ) and Validation Reviews.

We perform Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Re-qualification on clients behalf.