Areas of Application

Food Safety

Food safety is best attained through the identification and control of hazards in the production and manufacturing of food products. It is a scientific discipline that describes how to process, prepare, and store food products in order to avoid foodborne diseases caused by a variety of bacteria, viruses, and parasites.

Process Development

Process development is necessary to ensure high product yields are obtained at all intermediate steps in the manufacturing process. Process characterization and qualification is key to ensure batch-to-batch variability is minimized and that critical control points meet specification every time.

Hazard Analysis

HACCP hazard analysis is used to determine the critical control points (CCP’s) in your manufacturing process. Scientifically validated critical limits must be established with monitoring and quality control testing implemented to maintain a total state of process control.

Corrective Actions Preventative Actions

Corrective actions are needed to eliminate the root cause of manufacturing failures and address non-conformances with preventative actions executed to stop their (re)occurrence. Often resulting in the refinement of work instructions, operating procedures can also be prepared to undertake product or intermediate reprocessing.

Biopharmaceutical Manufacturing

Biopharmaceutical manufacturing is more complex relative to the production of synthetic or traditional small molecule pharmaceuticals. Biologic therapeutics are highly complex macromolecules that require recombinant expression from living organisms, such as microbial or mammalian cells.