Without question, it is possible, with two different bulk bag handling systems, each placed into perfectly matching sanitary applications, performing the same mechanical functions, and each having achieved compliance, for one of the systems to provide significantly greater product safety confidence and regulatory readiness than the other. Whether the sanitary application requires handling of bulk-bagged material for in-plant use, for production re-sale, or for consumer purposes, it is crucial to select equipment that is specifically designed for sanitary use. Simply because a stock bulk bag handling unit is made of stainless steel does not make it optimally compliant for the application.
When assessing an existing system for the integration of sanitary bulk bag handling equipment, or when installing a comprehensive, turnkey bulk bag handling operation, the primary objectives should be as follows: protect personnel and product, ensure the regulatory compliance of all equipment, and align the equipment operation with required process standards and protocols. Bulk material processing facilities with sanitary operations, together with their most knowledgeable equipment manufacturers, must collaborate to meet these objectives.
Following the application assessment phase, when specifying bulk bag handling equipment for sanitary applications, there are typically four key areas of equipment design and construction that should be considered to ensure the system will provide optimal compliance contribution (OCC) that is specific to the operation. These areas of equipment design and construction are materials of construction (MOC), cleanability, contaminant abatement, and accessibility.
Application-specific design of sanitary bulk bag handling equipment enables each individual processing and packaging system to be integrated deep into the bulk material handing process without concern for introducing contamination, time-consuming sanitizing, or complicated inspections that are common with force-fit, general industrial units that are often specified into sanitary applications. While sometimes subtle in nature and physical appearance, these sanitary design differences, can be significant in their ability to aide in optimal compliance contribution (OCC).
Yet, even with the volumes of industry guidelines, third-party standards, and governmental regulations available to aid in addressing these objectives, many sanitary processing operations seem to unknowingly, or knowingly, tolerate process-inappropriate equipment. Such equipment is typically a re-purposed design from a general-industry application, and, though it may function suitably in a mechanical sense when placed into a sanitary application, such equipment negatively affects the operation’s sanitary compliance performance by unnecessarily increasing product exposure to contaminants, hindering cleanability and validation, presenting hazards to operators, maintenance, and inspection personnel, and reducing compatibility with sanitary facility design principles.
The application-specific construction of sanitary equipment should meet the FDA, current Good Manufacturing Practices definition for cleanability according to 21CFR110.40 of the Food Safety Modernization Act (FSMA). The application-specific design should also be assessed according to the Hazard Analysis & Critical Control Points (HACCP) guidelines. The equipment must have design features that proactively facilitate thorough cleaning and meet or reduce target cleaning times. Such features include: the elimination of internal angles, corners, and dead spaces to avoid accumulation of contaminants; angled-planes, rounded radius framework, highly finished plate, and stand-offs to reduce material build-up and speed material and moisture run-off away from product contact areas; and component frameworks cut from plate to eliminate exposed fasteners, joints, and crevices common with tubular assemblies. Additional protections for product and personnel, in support of OCC, according to 29CFR1910.217, include: machine hard guarding that permits pass-through of materials while guarding operators from contact with machine hazards; guarding that permits viewing of guarded processes, reducing the need to remove guards; and when guards must be removed, guard retention systems on the machine protect personnel during maintenance, validation, and inspection procedures.
Certainly, there are relative levels of effectiveness amongst what the market often considers sanitary-compliant bulk bag handling equipment. That will always be. But, production managers, process engineers, supervisors, EH&S staff, corporate management, and others involved in specifying and selecting sanitary bulk bag handling systems, must recognize the importance of these sanitary design and construction differences, educate themselves on the appropriateness of these differences for their applications, and move forward accordingly.
Dave Root is the applications engineering manager for National Bulk Equipment Inc. Root has been involved in design, mechanical, sales, and applications engineering management functions, across multiple bulk material handling product categories, and in varied industries, through the U.S. and internationally, with NBE for more than 15 years.
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