Validation of microbial reduction processes for low moisture foods

Low-moisture foods are generally perceived as safe from pathogenic contamination due to low water activity and dry processing environments. However, consumer illnesses caused by the survival of Salmonella in low-moisture foods have raised food safety concerns.

Since pathogens like Salmonella can survive in low-moisture conditions and may grow if a processing facility is unable to effectively manage the introduction of moisture, low-moisture products cannot be considered immune. Common low-moisture foods which can become potentially unsafe include chocolate, cocoa, confectionary products, dried milk, tree nuts, peanuts, peanut butter, flours, cereals, spices, pet treats and other foods.

Impact of Food Safety Modernization Act (FSMA)

With the implementation of the FSMA, there is an increased focus on the validation of preventive controls for all products regulated by the US Food and Drug Administration (FDA). This includes food production environments where, traditionally, concern about pathogenic organisms has been minimal because of the low water activity of the products. The product recalls caused by Salmonella have clearly proven that manufacturers should now aim to validate their control processes for products including nuts, spices, cereals, milling and dairy powder.

What is process validation?

The preventive control rule for human foods defines validation as – ‘Obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan on a whole, when properly implemented, is capable of effectively controlling the identified hazard.’

Process validation is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes. In other words, process validation attempts to:

• Ensure that the process parameters are the right ones and assures that a specific process will consistently produce the product;
• Find out any deviation from established parameters; and
• Identify control points in the context of preventive maintenance.

Validation should not be confused with verification where the applicable methods, procedures, tests and the other evaluations, in addition to monitoring, are intended to determine whether a control measure or the combinations of control measures is or has been operating as intended as well as to establish the validity of food safety plan.

How SGS can support

SGS’s laboratory experts, located in Chennai, claim to have a considerable expertise in the domain of process validation for low water activity products. They work with numerous clients in the confectionary, spice, cereal processing and nut sectors to design and perform robust process validation studies to confirm the critical times and temperatures needed for sterilizers, ovens, dry-roasters and oil roasters to reduce the level of Salmonella spp or a surrogate microorganism in ingredients and finished products by at least 5 log CFU/g.

This log reduction requirement varies based on the nature of the product. Process validation requirements as per Grocery Manufacturers Association (GMA) for Log Reduction of Salmonella is mentioned in the given table:

SGS’s R&D team begins the development of a process validation study by looking at the client’s production techniques and products. This will often involve a site visit or comprehensive information gathering phase, which is undertaken with the client. Once the complete understanding of the individual factors involved in the client’s processes is achieved, SGS’s experts identify the challenges involved in the process and product. They proceed with the necessary process parameters and procedures allowing them to execute a successful validation.

SGS Chennai laboratory collaborates with SGS global networks to expand its global reach and meet the needs of the spice industry and other low water activity product processors. The R&D center of SGS located in North Sioux City, US claims to have highly skilled professionals extending services to the spices industry globally, thereby harmonizing the process across the globe and helping to assure suppliers that their products are safe for consumers.

Validation helps to produce pathogen-free products

Apart from the regulatory and statutory aspects, this validation will help the processors of low-moisture foods, who may not have in-house expertise on food safety or microbiology professionals employed with them, to manufacture pathogen-free products. It provides a complete understanding to the customers regarding process effectiveness which can subsequently be adjusted based on the outcome of the validation performed.

Customers can use the data from validation to implement process controls, conducting verification activities and documenting control measures in food safety plans which in turn protect brand reputation and consumer confidence.

SGS is the world’s leading inspection, verification, testing and certification company. With more than 95,000 employees, SGS operates a network of over 2400 offices and laboratories around the world.