Recommendations for how to think about your food safety process
Irradiation as a Food Safety Mechanism
For the great majority of food products, clean and sanitary ingredient preparation and/or subsequent cooking (e.g. thermal processing) prior to consumption are the key steps taken to assure a safe output. But today, the growing interest in and market share of “raw”, “natural”, and “unprocessed” foods is leading to the evaluation of food safety techniques that can assure that dangerous pathogens are eliminated / inactivated while also preserving the natural character (eg taste, nutritional content, etc) of the product.
Irradiation, sometimes referred to as “cold pasteurization,” is one well-demonstrated and endorsed technique that can be used to ensure food safety. The FDA, USDA, and World Health Organization (WHO) all recognize the benefits of irradiation as a safe option for food safety, when appropriately implemented.
Irradiation has several major advantages against other forms of food safety processing, such as high pressure processing (HPP), as we have previously described. The focus of this writeup is to provide more concrete guidance as to how an irradiation program may be specifically designed, validated, and implemented for a food safety application.
Customers Have Choices in How They Leverage Irradiation Processing
Industry guidance such as ASTM’s F1356 and ISO 14470 provide recommendations for treatment of fresh, frozen, or processed meat and poultry products for pathogen control. While the primary purpose is to control pathogenic microorganisms and parasites, the extension of shelf-life by reducing spoilage microorganisms is also possible. Read more about what F1356 contains in our detailed overview.
What We Recommend for Meat and Poultry Products
Generally speaking, validating a radiation sterilization program involves two separate concepts:
- Establishing dose specification (i.e. minimum and maximum dose)
- Establishing that the process delivers dose within the prescribed limits in a robust fashion.
Tests for setting the dose specification and proving that the product can be processed within the dose specification are conducted separately. More details on how these differ are listed in the table below:
| Establishing Dose Limits | Validating Dose Delivery process | |
|---|---|---|
| Scope |
Establish a minimum dose that delivers pathogen reduction Establish a maximum dose at which product is still acceptable for sale |
Establish that a given irradiation process will deliver dose within the dose specification with appropriate statistical buffers to account for normal process variation. Typically this is called “dose mapping” |
| Responsible Parties |
Manufacturer (often uses external microbiological lab for product pathogen testing) |
Irradiation service provider |
| Time to Establish | Typically, several months | 2 weeks |
| Cost | Varies depending on manufacturer’s desired testing | Typically ~$5,000USD |
More on Establishing Dose Limits
Setting a minimum dose for an irradiation process is the responsibility of the manufacturer. Minimum dose for food safety in meat products typically will fall in the 3-8kGy range, although it is possible to have different values. A robust and common approach is to perform microbiological validation following ISO 11137-2. Alternatively, some manufacturers simply reference the log reduction values ranges listed in the F1356 standard as references for their minimum dose targets.
Setting a maximum dose is also the responsibility of the manufacturer. This may be done by test-irradiating the product at its legal limit (in the US, this is specified for foods, depending on the type of product, in 21CFR179 and animal feed in 21CFR579). If the product is overly degraded at this limit, a lower limit may be selected or the product nutritional content could be augmented to account for losses from processing.
Validating The Dose Delivery Process (Dose Mapping)
To validate that dose can be delivered in the range specified by the manufacturer, the irradiator evaluates the dose distribution within the product’s routine processing configuration. This dose mapping process involves placing single-use sensors inside the product to form a “heat map” of how radiation is distributed inside a typical box. Once the heat map is established to be inside of parameters (with buffers included for statistical uncertainty), the results of this dose map can be used until the product configuration is changed or obsoleted.
Dose mapping also offers an opportunity for optimization. Typically manufacturers will consolidate multiple sale units or bulk material in boxes for irradiation. For E-Beam in particular, the results of dose mapping may be evaluated by an expert to recommend highly efficient boxing configurations to produce the lowest possible cost-per-pound for irradiation processing. At NextBeam, we will always provide recommendations to improve efficiency when we see opportunities to do this for our customers.
Process Recommendations Per the F1356 Standard
NextBeam is accredited to the standards of ISO 13485 (Quality Management Systems in the Medical Industry) and ISO 9001 (Quality Management Systems) for the provision of radiation processing in accordance with ISO 11137 (Radiation sterilization for medical devices).
These stringent standards and regular audits from some of the largest medical device companies in the world speak to NextBeam’s ability to set and meet high standards for quality. The concepts used for control and inactivation of microbes for medical device sterilization and food processing are similar:
- Risk assessment and establishing controls proportional to risk throughout the process
- Personnel hygiene
- Environmental and facility controls, such as pest/rodent control
- Identification and traceability of product lots and quantities from receiving through processing, QA review, and return shipment
- Process monitoring to ensure products are treated according to approved specifications
We also welcome customer visits and audits as necessary to demonstrate the processes and controls used in our operations.
Irradiation is an Opportunity to Reduce Risk of Contamination, Spoilage, and Create Premium Products
Irradiation offers a unique set of characteristics as compared to other food safety processes:
- Product can be irradiated in final packaging: Reducing risk of introducing contamination into sealed packages after treatment and simplifying logistics.
- Reduce food waste and rejected shipments: Significant shelf life extension reduces food waste and can help prevent shipments from being rejected during receiving inspection
- Product is Minimally Affected: Irradiation best preserves the “natural” characteristics of raw, whole foods that customers value, like taste and nutritional content. Indeed, it’s typically difficult to tell irradiated from non-irradiated products, unlike the substantial loss in flavoring and nutritional compounds that occurs from high temperature, such as dry heat and steam-based kill steps, or or high pressure processing.
At NextBeam we are constantly growing the business we do in the food space. Contact us for a free consultation to discuss the best options for your particular product needs.
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