As the U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) begins to be implemented, food packagers can no longer rely on business as usual. The law, which was signed by President Barack Obama on January 4, 2011, shifts the food industry to a risk identification and mitigation strategy to protect food safety, after decades of taking a reactive stance.
Provisions of the food safety law require enhanced product traceability, give regulators greater access to production records and expand record-keeping requirements. In fact, under FSMA, food packagers must draft risk-assessment plans identifying potential hazards and develop and document a corrective plan of action.[1–3]
Although regulations are in various stages, there’s no doubt FSMA will require changes on packaging lines. And experts speaking to Packaging Machinery Manufacturers Institute (PMMI) members at PMMI’s Executive Leadership Conference in April made it clear that food packaging equipment suppliers will need to make safety, quick sanitation and trace-and-recall capability top design priorities.
Under current Good Manufacturing Practices (cGMPs) governing the industry, pharmaceutical packagers must meet similar requirements.
“I’ve observed a continuing trend of food manufacturers coming closer and closer to the same kinds of practices—detailed documentation and record keeping, step-by-step manufacturing and monitoring,” says Eric Greenberg, a food and drug law attorney in private practice in Chicago predicting, “FSMA will accelerate this trend.”
Along with the shift to more proactive food safety strategies, FSMA will require food companies to adopt Hazard Analysis and Critical Control Points (HACCP) methods. These methods center on analyzing every step of a process to identify where hazards might occur. The food manufacturer is then expected to implement controls at those points and see to it the controls are practiced 100 percent of the time.
In turn, Greenberg predicts, the adoption of HACCP practices by food packagers “will inspire packaging [material and machinery] manufacturers to undertake such controls voluntarily. As a result, we may see a transition to more sophisticated food processing and packaging equipment.”
Since food safety risks often involve the introduction of contaminants or the failure to remove or render them harmless, many CCPs involve packaging materials or packaging equipment. For food packagers complying with FSMA, that will mean considering more stringent cleaning regimens, integrating additional inline quality monitoring equipment (e.g., machine vision and/or X-ray inspectors and metal detectors) and installing risk-mitigation equipment (e.g., inline cap sanitizing systems).
To comply with FSMA, packaging equipment, including inspection systems, will need to be installed, validated and continuously monitored to confirm performance consistently meets expectations. Validation and performance must be documented.
Recently, PMMI asked food packagers about the changes needed to meet FSMA requirements, and many of the responses focused on designs not unlike those of packaging machinery on pharmaceutical lines:
• Eliminate equipment areas and surfaces that can trap and grow bacteria
• More waterless and dry-process technology
• Increased modularity and cleanability
• Larger clearances under and above equipment for easier cleaning and maintenance
• More stainless steel construction (Figure 1)
• Design machinery to keep infrastructure changes at a minimum for installation
• Physical barriers between high- and low-risk areas to prevent spread of contamination
“Unquestionably, concepts are being borrowed from the pharmaceutical realm,” says Greenberg. “This has been particularly true of regulators, but there’s also been a trend of food companies voluntarily borrowing concepts.”
Other hygienic design features include smooth welds, the elimination of exposed fasteners and crevices that collect dirt/debris and the use of angled surfaces to prevent pooling of water, cleaning agents or other liquids. Hygienic design also tends to be modular, either with downtime-reducing quick disconnect/connect hardware or clean/sterilize-in-place functionality that eliminates, or at least minimizes, the need for disassembly/reassembly (Figure 2).[7, 8]
Record keeping ranks as a primary cGMP requirement for the pharmaceutical industry, and automated record keeping is replacing old paper-based systems. Regulations outlining the criteria for converting electronic records, electronic signatures and handwritten signatures to electronic records equivalent to paper records and handwritten signatures are defined in 21 CFR Part 11.
As a result, depending on how final regulations are written, food packagers may be able to comply with FSMA record-keeping requirements by adopting technologies already validated in the pharmaceutical industry, including those offering Part 11 compliance.
Track and Trace
Federal traceability requirements to help prevent counterfeiting and diversion of pharmaceutical products appear to be stalled for now. However, pedigree laws looming in California (and already in effect in countries like Turkey) have spawned hardware and software capable of providing the coding and database information needed to authenticate product from point of packaging to point of purchase. If a product quality problem is detected, pedigree information can also be used to quickly identify, locate and recall affected products. These hardware and software technologies could help food packagers meet FSMA’s traceability requirements.
The evolving pharmaceutical traceability effort now often consists of an integrated system from a single vendor. Equipment typically involves coders/printers capable of applying alphanumeric, one- and/or two-dimensional bar codes to containers, labels or packaging materials, plus inspection systems to verify code quality and capture code information along the packaging line. Hardware also includes code-capturing devices that supply chain partners, law enforcement personnel, regulators and consumers use to authenticate product. Although many proprietary code-scanning devices exist, increasingly, this function is often performed with a smartphone.
Software captures and links code data to establish parent/child relationships from primary container to pallet, organizes that information in a database and controls access to it.
Although printing ranks as the most common method to add traceability information to pharmaceutical packaging, radio frequency identification (RFID) tags can also serve as the code carrier. However, RFID tags generally are viewed as too expensive to use on primary packaging. On the other hand, RFID tags can be scanned without being within the reader’s line of sight. In addition, some tags can be equipped to perform other functions. For example, tags for sensitive products could also monitor temperature and provide an alert if conditions exceed desired parameters during transport and storage of the product.
Food packagers searching for ways to comply with FSMA should attend PACK EXPO International 2012 (October 28–31, 2012; McCormick Place, Chicago), where The Pharmaceutical Pavilion will serve as a source to evaluate and compare pharmaceutical equipment and practices and The Food Safety Summit Resource Center will offer food-specific references. In addition, the concurrent Conference at PACK EXPO includes tracks devoted to food safety and track and trace on Monday and Tuesday, October 29 and 30.
Julie Ackerman is the senior director, public relations & communications, at PMMI.
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