PROCESS VALIDATION
Deibel Laboratories helps our clients to scientifically validate their process lines in compliance with HACCP/Food Safety plan requirements.
Process Preventive Controls are required to be validated when first implemented and after any significant change in the process as directed by the Food Safety Modernization Act (FSMA). Validation of a heat treatment as a process control is discussed in FDA draft guidance (21 CFR §117.160).
The Deibel Laboratories Centers of Excellence for Process Validations have state of the art testing and pathogen laboratories specifically designed and segregated for Process Validations. Deibel Laboratories has helped many clients to scientifically validate their process lines in compliance with HACCP/Food Safety plan requirements.
Deibel Laboratories uses a science-based protocol that aligns with regulatory expectations for process validations, and we have a library of pathogen surrogate organisms available for use. To assure the surrogate is acceptable in unusual food matrices, a Surrogate Compatibility Study is used to verify that the surrogate is appropriate and fit for purpose.
Our Process Authorities have validated a variety of food processes including:
- Extrusion
- Baking (batch and continuous feed)
- Smoking and Fermentation
- Nut roasting (air, oil and steam)
- Panning
- Drum Roasting
- Juice pasteurization
- High Pressure
- Irradiation
The FDA expects that food manufacturers will validate their thermal process to ensure that they can achieve a 5 Log reduction of Salmonella, Listeria or other target pathogens. According to regulatory requirements, a history of negative microbiological results for a pathogen in a finished product is not sufficient to determine the adequacy of a process in reducing the presence of the pathogen target.
We also conduct preliminary studies for our clients to establish Critical Limits for processes that will be validated. These include determining D and Z values for target pathogens in your product matrix. In addition, Deibel Laboratories conducts studies for the verification of consumer cooking instructions.
For more information, please contact Sales at Sales@deibellabs.com.
