Aseptic food processing involves sterilizing a product that is then filled and packaged under sterile conditions into a sterilized container before being exposed to the environment. Aseptic processing results in shelf-stable products that have a long shelf life. This is a complicated process in which many critical factors must be managed, monitored, and documented.
The COVID-19 pandemic has shown us that this type of processing is a smart investment that will continue to pay off. As restrictions during the pandemic caused bottlenecks and scarcity in the fresh food supply chain, consumers flocked toward shelf-stable items, revealing demand. Aseptic processing and packaging will continue to close supply chain gaps as manufacturers are freed from providing refrigerated or frozen storage.
While the demand for shelf-stable items is here to stay, aseptic processing is a complex undertaking with many variables not seen in traditional food processing—from product and process design, to instrumentation and records, to training and monitoring. To maximize your investment—and to protect the end consumer—it’s important to fully understand the processes and commit to maintaining and monitoring aseptic production performance. In other words, it’s not a “build it and forget it” endeavor.
Based on my more than two decades working globally in aseptic processing and packaging facilities with design and production teams, I’ve seen in real time the successes—and challenges—of aseptic processing operations. Here are my top seven strategies for long-term aseptic processing performance, including designing, monitoring for quality assurance, training, and improving continuously.
1. Coordinating Processing Operations
Every part of the system, from purchasing, utilities, ingredient dosing, batching, and mixing, to the thermal process, control, and data recorder, must be designed with the purpose of operating as designed—concurrently—at all times. Aseptic processing and packaging require high attention to detail, and small mistakes in any of these areas can lead to costly problems.
I’ve seen large quantities of product destroyed because a simple gasket wasn’t replaced on time, which led to contamination. It’s worth the time, effort, and expense to execute a flawless design from the very beginning, in which the key stakeholders of the company—including quality assurance and safety and experienced and qualified engineers—produce a good design, taking into account every aspect of the process line, including utilities, sanitation, and environmental equipment.
2. Success Comes from a Good Plan
Aseptic processing design requires planning for several scenarios based on the flexibility needed by the producer as well as the variability in ingredients and supply chain. Aseptic “hidden costs”—such as downtime for maintenance and sanitation, preventive maintenance, calibration, and inspections—should be considered from the start. Design that simplifies these operations allows faster turnaround time and higher productivity.
It’s important to involve a process authority from the beginning to ensure that all legal requirements are considered and that future modifications to the line will be minimal. Aseptic processing relies heavily on the scheduled process given by a process authority, as part of a complete food safety plan, to produce safe and high-quality products. During the design stage, it’s a good idea to develop a design/food safety plan where several control points will be identified and design allowances made for instrumentation, recordkeeping, and calibration.
3. Validation Is Not a One-Time Activity
Validation is typically associated with commissioning and hazard analysis and critical control points (HACCP), but in real life, it’s a continuous activity that is closely tied with operations and quality. During commissioning, validation activities are carried out to ensure that the production line and packaging equipment will perform as designed. Automated control systems, clean in place, and sanitation, as well as process line, need to be validated periodically to ensure they are still working as planned. Other activities, such as maintenance and change management, should also be considered part of continuous validation.
4. People Make the Difference
This is one of the biggest culprits in waning vigilance over time for aseptic processing. Every employee involved in the validation of aseptic processes—operations, quality control, plant management, maintenance, and engineering—should receive training on high-quality and safe foods. Training programs should adhere to both current good manufacturing practices (cGMPs) and the Better Process Control School. Employers should also offer ongoing professional development and refresher courses. It’s important that management commit beforehand to the training tenets of aseptic processing. Training is a great way to combat complacency over time.
5. Quality Assurance
Testing goes hand in hand with coordinating processes. The failure to maintain accurate records and test products periodically can cause the quality to diminish, risking contamination and serious illness, including contamination with Clostridium botulinum. The aseptic process is designed and validated to inactivate all microorganisms that could cause spoilage or pose a public health threat, and the scheduled response must be followed carefully. Aseptically processed foods require stringent recordkeeping. As the saying goes, if you didn’t document it, it didn’t happen.
In addition to recording each of the control points at reasonable intervals, records should also show the actions taken in case of deviation from the schedule. Records must also be kept of quality checks and testing results. These documents must be stored for at least three years, either electronically or through a paper trail.
When routine microbial testing is used, a sampling schedule should be agreed upon beforehand. The samples themselves should be incubated in a hot room upon collection for seven to 15 days to check for package bloating. Microbial tests must also be adequate depending on the product, and should include a decision as to whether mesophilic anaerobic spore testing is needed. All considerations should be part of the food safety plan.
6. Continuous Improvement
Aseptic processing is an intricate and elaborate behavior, where every detail can make the difference between profit and loss. Aside from a careful preventive maintenance program, change control, and daily record review, it makes sense to anticipate deviations and to operate with scrutiny to help decrease the incidence of overlooking a problem. Batch, lot records, critical control point records, and closing data should all be reviewed by quality assurance to ensure critical control point parameters are acceptable. If any parameters are outside of the schedule, a deviation process should begin. Immediately quarantine the products and perform a root cause analysis to determine the next steps for the product. Products may be able to be reprocessed or may have to be destroyed to prevent the possibility of adulterated product going to the public.
7. Hidden Costs
Above, I talked about the benefits of aseptic processing and its viability for both the supply chain and the food supply, but it’s important to acknowledge the costs involved in doing it correctly, safely, and in compliance with FDA regulations. Initial capital investment could be as much as two to three times that of fresh production. Additionally, evolving packaging requirements will initiate costs for R&D, so those costs should be figured in as well.
If you’re considering adding aseptic processing to your production line, or simply interested in remaining vigilant about an existing line, consider engaging a consultant who can guide your team through the countless challenges. With careful design, recordkeeping, and training, you’ll successfully navigate the complexities and pioneer successful long-term aseptic processing.