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34 ISE Magazine | www.iise.org/ISEmagazine Getting to good Good manufacturing practice prescribes thoughtful analysis and preparation to design a facility properly. Often, a production-based flow chart or step diagram is employed prior to the facility design phase to place the manu- facturing steps into a logical order. The physical distance between production steps should be evaluated to minimize, to the extent possible, material move- ments. Appropriate considerations also should be made for properly inspecting finished goods and safely loading mate- rial onto equipment for transportation to the customer. Generally speaking, a well-designed facility minimizes the distance that a material must travel dur- ing the production process, resulting in an efficient and properly sized manufac- turing plant. Relatedly, good manufacturing prac- tice also prescribes that a facility should be organized in a manner that prevents unintentional addition of substances at the wrong place, at the wrong time or as a result of cross-contamination. These considerations can work in concert with, or in contrast to, the efficiency concepts discussed above. Within the manufacturing space, spe- cific emphasis should be placed on mini- mizing product contamination. Product contamination may result in the unin- tentional (nonpurposeful) addition of a substance during the manufacturing process or the intentional (purposeful) addition of a substance, but at the wrong location or in a quantity not originally specified by the production plan. Common examples of unintentional addition occur where materials from two separate production processes are placed near each other (e.g., two adjacent production belts) and the loading mech- anism, such as a hopper, is not properly sealed or segregated. Small amounts of one type of material may spill over into the second material's production line, resulting in contamination. (Incorrect or inconsistent storage and labeling of raw materials may also contribute to the selection of inappropriate raw materials for use in a production batch. Segrega- tion of raw materials helps ensure that the correct raw materials are used as in- tended.) A second type of unintentional addi- tion may result from malfunctioning or improperly calibrated equipment. For example, lubricants and hydraulic flu- ids are common and play a critical role in automated production equipment. However, this equipment could fail, and small amounts of lubricant could drip onto production surfaces. In both instances, proper facility de- sign and planning play a critical role in minimizing the potential for contamina- tion. Increased separation between pro- duction equipment reduces the chance that intentionally added substances will carry over into other processes. Physical barriers between production equipment, such as processing belts and lines, might minimize the possibility that process- ing fluids contact food packaging. Each of these steps, however, can add incre- mental costs to overall facility design. Indeed, they might run counter to ef- ficiency concepts like minimization of material movements. Ultimately, the manufacturer is re- sponsible for determining the appropri- ate balance between designing an effi- cient facility and minimizing product contamination. A fully separated manu- facturing space may result in fewer con- tamination events; however, the poten- tial contamination risks associated with a more efficient design could be miti- gated by increased product and equip- ment inspections. One advantage of the FDA's good manufacturing practice concepts is that the agency lets the manufacturer deter- mine the appropriate balance between efficiency and quality, recognizing that the manufacturer is in the best position to make this decision. Process control Throughout the manufacturing pro- cess, many steps require strict adherence to specific measurements or tolerances. Complying with these requirements is often critical to ensuring that food packaging is manufactured consistently. Consistency, of course, is important both to the functionality of the product and the expectation of the consumer. Within these manufacturing prac- tices, however, companies are often left to determine for themselves to which degree of specificity a tolerance must be met. These tolerances relate not only to physical dimensions and specifications but also to the complex mixtures of chemicals and substances that are blend- ed and reacted to produce a finished resin. Adhering to stricter specifications (beyond the minimum necessary to achieve the safe and effective production of the finished food-contact material) may come at additional relative cost, and the incremental benefit in quality and consistency may decrease. Physical tolerances can play a piv- otal role in ensuring that food packag- ing performs as expected. For example, bottle manufacturers often work with third-party suppliers of gaskets and closures that make sure the bottle and closure combine properly to form a seal. This seal, in turn, prevents leaks or spoilage of the food. Compliance with specific measurements and specifications are essential to make sure that the two products function properly when used as intended. Of course, the degree of accuracy needed to achieve a complete seal de- pends on various factors, including the materials used to produce the bottle and the seal, the temperature the finished product will be subjected to (extreme heat and cold may expand or contract the materials) and how long the mate- rials will be in contact with food (cer- tain food contact materials may interact differently with specific food types over time). Ultimately, whether a product must meet a designated specification within a specific degree of tolerance must be evaluated on a case-by-case basis by considering the intended use of the product and the potential health or