Process Validation Services

At Novolyze, we are in the forefront of process validation. Our cross-functional team of validation experts, mainly composed of food microbiologists and process engineers, is able to assist at multiple stages of a validation project:

  • Definition of a Validation Strategy
  • Execution of the Validation
  • Development of a Validation Report

We rely on state-of-the art infrastructures, installed in a pharmaceutical-grade environment at our R&D Center in Dijon, France. Our infrastructure includes BSL-1 and BSL-2 Labs, bioproduction facilities as well as pilot processes.

Our process validation services include the following items:

Definition of a Validation Strategy

Identification of the validation critical parameters taking into account the products, processes and pathogens of concern. Development of a protocol for the in-plant process validation, including such items as the methodology to prepare the surrogate microorganism, the procedures for inoculating the surrogate, the quantity to prepare, the placement and recovery procedures in the process.

Surrogate Inoculation, Confinement and Enumeration

Inoculation of a surrogate microorganism on a selected food product with the availability to provide a few grams to several tons of inoculated product. Confinement of the inoculated food in portions (bags, balls etc.). Post-process enumeration of the surrogate microorganism using either selective or non-selective media.

Thermal Mapping / Temperature Distribution / Heat Penetration Studies

Verification that all the products will be subject to the same thermal environment conditions such as identification of the cold and hot spots in a specific piece of equipment. This is a critical step to a scientifically-based process validation.

Microbial Death Time Studies

Study designed to determine the resistance of a specific bacteria in a defined product and for an inactivation stress, allowing calculation of the D- and z- values – Thermal Death Time (TDT) studies, Chemical Death Time (CDT) studies, etc.

Surrogate Screening & Selection

Screening of potential surrogate organisms for appropriate resistance relative to a specific target pathogen, product and kill-step. Determination of the kinetics of thermal destruction for the selected surrogate microorganism (D- and z- values)

Residence Time / Dwell Time Studies

Definition of the amount of time a particular product spends in a specific process, which may influence the protocol of a validation study (choice of the surrogate, placement of the surrogate in the equipment).

Validation Report

Elaboration of a report including such items as process description, description of the tested products and of the validation protocol (incl. analytical methods), summary of the collected data as well as study conclusions.

Microbial Risk Assessment

Assessment of a food product relative to microbiological hazards, as well as selection of the performance criteria relative to the organisms of public health concern.

In-Plant Support

Assistance of one of our experts to perform process evaluations (thermal mapping, dwell time studies…) or provide support during validation trials (placement and recovery of the surrogate in your process etc.).

Analytical Work

Evaluation and understanding of a product’s intrinsic properties (pH, water activity, moisture etc.) and physical properties (size, shape, structure etc.).

Stability Studies

Evaluation of the stability (concentration/resistance) of a surrogate when inoculated on specific food matrix. Possibility to test ambient and refrigerated storage.

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