Ensuring product safety in aseptic food processing

In our previous post on aseptic processing and packaging, we discussed the potential benefits aseptic processing can offer to food and beverage manufacturers looking to add new products or expand their distribution range. Because of its unique processing requirements, however, there are several key considerations to keep in mind when adding aseptic to your operations.

The prior post discussed proper planning for possible contingencies and ensuring all staff involved in the aseptic processing is thoroughly trained. Also, we reviewed best practices to successfully bring your aseptic production online quickly.

In this post, we will review the most important endeavor in aseptic processing—keeping food safe. Because aseptically processed and packaged products are shelf-stable, not properly produced or packaged foods can be deadly if consumed.

Aseptic processing considerations to ensure food is properly produced and packaged

The good news is that aseptic processing is not new and the FDA together with industry and academia have developed clear guidelines for validation of the preparation, processing and packaging. The aseptic process is designed and validated to inactivate all microorganisms that pose a threat to public health and those that cause spoilage. As a result, products are produced that are commercially sterile and can have a long shelf life.

Following are six key considerations to ensure aseptic food products are safely produced:

1. Coordinating aseptic food processing operations

Aseptic processing and packaging consist of several operations that need to work safely concurrently, and any misstep can end in an unsafe product.  Every part of the system—from the utilities, ingredient dosing, batching and mixing, to the control and data recorder—must be fit for purpose and perform as designed at all times. It is necessary to have a plan to validate, verify and control maintenance and changes made to each of these units to ensure the safety of the products.

2. Filing with the FDA

Each product must be filed with the FDA. The filing documents must contain these components:

• The thermal process,
• equipment sterilization and maintenance of sterility,
• filling and packaging machine validation
• and final product, which has been validated using a combination of microbiological and physicochemical tests.

This follows a comprehensive food safety plan which includes very thorough record-keeping of the critical factors.  Be sure you are monitoring and recording data from all your critical control points (CCPs). There are typically five in aseptic processing, which we covered in the previous post.

3. Testing your aseptic food process for quality assurance

While products made under the filed conditions are in principle safe, it is normal practice to test a few samples for positive release; the sampling program has to be agreed upon beforehand. Typically, a few samples are incubated in a hot box for seven to fifteen days to make sure there are no off-orders or observable package bloating.  Even though the aseptic processes are validated, it is a good idea to have the in-house microbiology lab perform aerobic plate count (APC) and yeast/mold tests to rapidly detect defects in post-processing and package closures. If your product is low acid, then the QA tests should include mesophilic and thermophilic anaerobic spores, which are the hardest to eliminate and the ones that have the potential to produce Clostridium botulinum.

4. Monitoring for deviations

QA management should always review these batch or lot records as well as data on closure integrity to ensure that the CCP parameters are in the control. Document any deviations observed in the CCPs and apply the deviation plan. If this does occur, quarantine products and pursue different action or testing, such as performing a Root Cause Analysis (RCA) to determine corrective action.

5. Creating a product release procedure

Facilities should develop and implement a product release procedure outlining the responsibility and protocols for the release of products, including deviations management. This program also applies to the procedures for releasing quarantined or held product. These procedures might include outlining process measures that demonstrate that products are compliant with specified requirements or that products that do not meet the specifications are safely disposed.

6. Keeping proper records for aseptically processed foods

As the FDA saying goes, if you didn’t document it, it didn’t happen. Records for all products released should be maintained and show the product’s name and identification, confirmation of checks and what happened to the product, whether it was released, incubated or held. If a held product is released, that should also be documented, detailing how much of that product was held and why. Furthermore, regulation requires that these production records, either in the form of a secure electronic copy or an old-fashioned hard copy, are safely stored and easily accessible for at least three years.

A product release program, successfully followed, will only allow compliant products to be released to the market. And that means all your aseptic food and beverages will be the safest and highest quality they can be.

Learn More

With proper planning, implementation, operation and monitoring, aseptic processing can produce high-quality packaged goods that are shelf-stable for long periods of time. Leverage our team of food safety specialists to help you navigate the complexities of integrating aseptic processing into your unique facility.

To learn more about aseptic processing and other food and beverage advanced manufacturing techniques, view our on-demand advanced manufacturing webinar series.

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