In the food and beverage and pharmaceutical and biotech industries, contamination-free processing is essential for full compliance with industry validation standards. The potential for contamination in manufacturing applications increases with the introduction of peripheral components, such as flow measurement instruments, that help maintain process parameters within acceptable limits. To prevent this from happening, these devices must themselves meet standards set by governing agencies to ensure that there are no weak links in the sanitary chain.
This article describes the development of the sanitary equipment standards governing the processing industries. It explains the differences between hygienic standards in the United States and European markets and offers guidance for end users who must ensure that their flow measurement devices comply with recognized industry regulations.
Thanks to today’s expanding global economy, the U.S. marketplace now includes products imported from all over the world. Domestic food and beverage processors typically specify 3-A Sanitary Standards, Inc. (3-A SSI) approval on all process-related equipment. This nonprofit association, which represents equipment manufacturers, processors, regulatory sanitarians, and other public health professionals, has established a number of globally recognized sanitary standards and accepted practices for dairy and food processing equipment and systems. In some cases, food and beverage processors also require the National Sanitation Foundation (NSF) and Underwriters Laboratories (UL) labels on components that come into direct contact with the processed medium.
The sanitary standards put in place by 3-A SSI have been developed for a wide range of production equipment used in the dairy and egg processing industries. They serve as a reference under the Grade A Pasteurized Milk Ordinance (PMO), the official regulatory document for the National Conference on Interstate Milk Shipments (NCIMS). These standards may also be required under many state and local regulations.
The NSF has traditionally developed standards for equipment used in food service and retail foods. Over the last few years, however, the NSF has also been involved in developing standards for food processing equipment. The NSF and 3-A SSI recently collaborated on standards development for meats and poultry equipment (3-A/NSF 15159), the results of which are now under review by an International Organization for Standardization working group.
Equipment manufactured in Europe for sanitary processing applications must carry the European Hygienic Engineering & Design Group (EHEDG) stamp of approval. Unlike 3-A SSI, EHEDG does not establish sanitary standards. Rather, it publishes guidelines for the construction and design of food processing equipment, as well as for cleanability testing performed in EHEDG laboratories.
The primary intent of 3-A SSI and EHEDG—the application of sound sanitary principles in food equipment manufacture—is the same. Both organizations represent equipment manufacturers, food industries, research institutes, and public health authorities with the aim of promoting hygiene during the processing and packaging of food products.
For many years, authorization to use the 3-A SSI symbol on flowmeters and other process equipment was determined by a system of self-certification. This system changed in 2003, when the requirement for a third party verification (TPV) inspection was implemented for 3-A licensees. The TPV procedure was completed for all standards in 2007.
The TPV program is designed to enhance the integrity of the 3-A SSI programs by affirming that equipment fabricated in accordance to 3-A sanitary standards or processing systems are manufactured and installed in accordance to 3-A accepted practices. The independent inspection programs of 3-A SSI provide assurance of hygienic equipment design, thereby benefiting regulatory sanitarians, equipment fabricators, processors, and consumers.
While 3-A SSI’s requirement for TPV more closely aligns its certification process with that of EHEDG, key differences in equipment design requirements remain. This divergence is due, in part, to the different levels of cleanliness specified by each organization.