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.
Dr. Coronel is director of food safety and thermal process authority at CRB. Reach him at [email protected].
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