Process Validation Services

Novolyze specializes in the qualification and production of stabilized, ready-to-use surrogate microorganisms and validation kits. Our team of experts can assist at multiple stages of a validation project: from the microbiological risk assessment of a food product, complete TDT studies to determine the heat resistance of a bacteria in a product for a food process, temperature distribution studies to the production of proprietary surrogates for preventive control validations. For an overview of our services, see below.

Services

Analytical work

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

Thermal Death Time (TDT) Studies

Study designed to determine the thermal resistance of a specific bacteria in a defined product and for a defined kill step (heat, heat & steam . . . ), allowing calculation of the D- and z- values.

Surrogate Identification & Selection

Screening of potential surrogate organisms for appropriate thermal 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)

Inoculation / 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. Post-process enumeration of the surrogate microorganism using either selective or non-selective media.

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 Preventive Control Validation Protocol Definition

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 equipment . . .

Process Authority 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.

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 . . . ).

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.

In Plant Support

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