No one ever said 3-A Sanitary Standards Inc. (3-A SSI) and the European Hygienic Engineering and Design Group (EHEDG) guidelines were supposed to be compatible or directly interchangeable in an “apples to apples” sense. In fact, they were conceived at different times, in different parts of the world and with different needs in mind. But, in an “apples to oranges” sense, the standards/guidelines are converging—actually, harmonizing is a better word—to benefit hygienic equipment makers and machine builders around the world, as well as food and beverage processors. This ongoing harmonization has the added potential of making equipment more food safe while possibly reducing design costs.

Article Index:

• Different times, different worlds
• What’s different and why?
• Current state of harmonization: Get involved!
• Manufacturers and harmonization
• Benefits of harmonization

Different times, different worlds

3-A Sanitary Standards Inc. has been around since 1920 and is recognized as a certified mark of approval for sanitary equipment design within the industry and by regulators. Founded in 1989, EHEDG is the recognized set of guidelines for sanitary equipment design in Europe.

3-A standards were initially intended for milk pipe fittings; the designation 3-A was derived from the cooperation of the three groups (professional sanitarians, equipment fabricators and processors) that worked together to develop the standards. The International Association for Food Protection, Food Processing Suppliers Association, International Dairy Foods Association and American Dairy Products Institute—along with the 3-A administrative symbol council, a representative of the USDA and FDA—are founding members of the current organization, 3-A SSI.

3-A SSI specifies the criteria for the design and fabrication of equipment that comes into contact with food. Specifically, 3-A SSI’s goal is two-fold: to protect food from contamination and ensure all product contact surfaces can be mechanically cleaned and easily dismantled for manual cleaning or inspection. Equipment covered by 70 different 3-A SSI standards includes vessels, filters, pipes and fittings, pumps and mixers, heat exchangers, conveyors and feeders, instruments, concentrating equipment and farm/raw milk and cheese and butter equipment.

3-A SSI follows a modern consensus development process, consistent with the Essential Requirements of the American National Standards Institute for standards development and document maintenance. 3-A SSI standards are accepted by both USDA and FDA for evaluating equipment compliance and cGMPs, as well as requirements under HACCP. In 2003, 3-A SSI implemented a Third-Party Verification (TPV) inspection program for all 3-A Symbol holders. Complete details on the TPV process can be found at www.3-A.org.

Located in Frankfurt, Germany, EHEDG is a consortium of equipment manufacturers, food processors, research institutes and public health authorities. Current membership includes more than 1,011 individuals, 230 companies and 30 institutes. EHEDG has regional sections in Europe and other countries including the US, Mexico and India. Its main goals are the promotion and improvement of hygienic engineering and design in all aspects of food manufacture. While it doesn’t have standards, it does offer guidelines that help fulfill European legislation requirements. EHEDG has active working groups for improving and creating guidelines, provides training materials and sessions, certifies equipment and has a yearbook and yearly world congress.

EHEDG’s 42 guidelines are referenced by international organizations. The group offers equipment certification by EHEDG-accredited test institutes and maintains a database of certified equipment on its website (www.ehedg.org). The certification methods are continuously being developed and complemented by new test methods.

In 2000, EHEDG established the EL certification scheme for liquid handling equipment. This certificate was mainly intended for equipment that could be cleaned in place without dismantling. The equipment was certified (and a logo was placed on it) if it met EHEDG Document 8 Hygienic equipment design criteria. The equipment was subjected to practical testing using Guideline Document 2 to demonstrate compensation for noncompliance for essential technical or functional reasons and suitability for cleaning-in-place (CIP) applications.

In 2009, EHEDG began revising the EL certification scheme and introduced several new certificate types. Equipment was classified into two groups: Class I (CIPable) and Class II (must be dismantled for cleaning). Equipment used in aseptic applications can be certified as EL Aseptic and ED for dry cleaning procedures, according to EHEDG.

What’s different and why?

Many equipment suppliers are already global. In many cases, they operate in Europe and sell their products not only on that continent but in the US and other parts of the world as well. Consequently, they must show conformance to both 3-A SSI and EHEDG. For example, GEA supplies hygienic and aseptic components for liquid processing, especially for dairy, beverage, food, chemical and pharma applications, says Bastian Tolle, senior vice president, GEA product group management for flow components. GEA flow components are accepted worldwide through certification from both bodies.

“SEEPEX is a German company with a large subsidiary in the USA, so we are definitely concerned with both 3-A SSI and EHEDG,” states Mike Dillon, president, SEEPEX. Although SEEPEX conforms to both sets of standards, the rules for each are different. Much of this difference has to do with cleaning.

Another supplier that finds it necessary to conform to the guidelines of both bodies is NGI, a Denmark-based producer of hygienic feet for machines used in Europe, the US and other parts of the world, according to Andre Brandon, NGI account manager.

“3-A certifications are based on theoretical validations that all design requirements have been met,” says Tolle. “Following EHEDG, the design is checked theoretically, and the hygienic execution of a component is validated by a standardized cleaning test. In general and in many cases, the 3-A standards provide more detailed requirements, such as exact radii, surfaces and the size of leakage outlets, while EHEDG is more generic and describes the intended effect. Furthermore, the hygienic design requirements are not fully aligned and vary in some details, such as material specifications or radii.”

“The 3-A sanitary committees write standards, but to be authorized to display its symbol, a manufacturer must provide drawings of the parts to ensure compliance with [for example] very specific O-ring placements, the radii of internal mating surfaces and finishes,” explains Dillon. “The committees also designate third-party inspectors to audit holders of the sanitary symbol authorization. Outside laboratories are required to ensure nonmetallic components not only adhere to [21 CFR Part 177], but they are tested to the USP Class III standard that measures the stability of materials so they do not contaminate food products. What 3-A does not do is determine if products can be cleaned in place.” 3-A SSI assumes that if its dimensional standards are met, the product can be cleaned in place—as long as the processor follows whatever protocol is compatible with the equipment, adds Dillon.

“For instance, a high-acid product like a strawberry purée may not require CIP protocols as extensive as cream cheese,” says Dillon. “The 3-A sanitary symbol committees are concerned solely with milk-based products. EHEDG has some general standards that can be met without inspection or testing, which are generally concerned only with CIP. EHEDG has licensed certain entities, like Purdue University’s food science department, to do simulated CIP that follows a specific protocol. But I know of products that have passed the EHEDG test protocols, but do not meet 3-A standards.”

While EHEDG may seem general or broad in terms of specific standards (which might be perceived as a shortcoming), this quality may be an asset for suppliers. Bühler Aeroglide provides conveying systems and dryers to the food and feed industry. It exports about 50 percent of its equipment outside the US, according to Steve Blackowiak, food safety manager. “The Europeans have done much better at documenting hygienic standards than we have in the US. Most of the equipment we supply to the food and feed industry is in the low-moisture food sector where guidelines are lacking, and often, we apply some sections of 3-A. But, the EHEDG guidelines include a broader range of hygienic design and are a better tool, mostly because they include more information and are better documented.”

As a result of increased regulation by FDA’s FSMA, conformance to hygienic standards will be an important part of improving food safety. “FSMA will require food facilities to maintain a written preventive controls [the PC part of HARPC] plan, and the proposed rules will clearly place more focus on ‘performance-based’ elements,” states Timothy Rugh, 3-A SSI executive director. “However, little guidance is available when it comes to how to achieve the desired goals or audit food equipment and hygienic design. Conformance to hygienic design and construction principles reflected in 3-A Sanitary Standards, as well as EHEDG guidelines, improves and facilitates cleaning and sanitation programs. It also facilitates validation. Without proper hygienic design and construction, validation of cleaning efficacy is difficult, if not impossible.”

Current state of harmonization: Get involved!

EHEDG produces guidance documents in local languages for food, beverage, cosmetic and pharmaceutical producers, as well as machine builders. It also provides training materials for hygienic design, says Knuth Lorenzen, president, EHEDG. “3-A and EHEDG documents are developed by experts. Cross-participation in both organizations ensures the harmonization of both documents. This is the final goal.”

“Food and beverage processors benefit from this harmonization as they can buy machinery worldwide that is hygienically designed and easy to clean,” states Lorenzen. “[Cleaning] can account for up to 70 percent of a plant’s total water consumption and water treatment costs, and [CIP] represents a massive opportunity for savings.”

“The efforts to harmonize our two organizations are continuous,” says Tracy Schonrock, hygienic design consultant. Schonrock is also a member of the 3-A board, sits on the EHEDG executive committee and belongs to the NSF council of public health consultants. “Each organization shares drafts of proposed documents for the other’s review and comment before publication. A liaison member from each organization participates in the meetings of the other and is often asked to speak on topics of mutual concern. The organizations routinely share training materials so they teach the same hygienic design principles.”

According to 3-A’s Rugh, “Participation in any of the 14 work groups, which oversee the standards and practices of 3A-SSI, is completely open. We have numerous hygienic design experts from around the world.” In fact, Rugh is always looking for volunteers to participate in the groups and supports a close relationship with EHEDG. “3-A SSI maintains a true, close working relationship with EHEDG. Our 3-A steering committee has EHEDG representatives. We have a liaison who participates in EHEDG meetings, and numerous subject matter experts, principally fabricators, are active in the document development work of both EHEDG and 3-A SSI.”

Harmonization will occur and reach its long-term goal when food industry stakeholders get involved in 3-A SSI and/or EHEDG. For example, GEA’s Tolle actively participates as a member of the EHEDG working groups for valve technology. Furthermore, GEA colleagues participate in several other working groups, e.g., hygienic pumps in both organizations. In fact, companies like Bühler are getting involved in the non-liquid areas of EHEDG. “Bühler participates in several working groups. These include building design, dry materials handling, bakery equipment and materials of construction,” says Blackowiak. Bühler is also leading a Swiss section of EHEDG. “We share our expertise during working group meetings and contribute to a number of hygienic design guidelines that ultimately enable safe food production,” adds Blackowiak.

Manufacturers and harmonization

Many suppliers would like to see 3-A standards and EHEDG guidelines merge. “The main goals would be fully aligning both standards and having identical executions that would meet the requirements of both standards without restrictions,” offers GEA’s Tolle.

“The goal and mission of both organizations are very similar,” says Blackowiak. “The ultimate goal would be to have one set of guidelines that could be used worldwide. While we must continuously pursue harmonization, this is something that will not likely be realized in the short term. Food safety norms are different around the world, and confusion remains over standards and regulations. Meanwhile, we do think it could be easier for global equipment manufacturers to follow the same standards for all regions.”

But, issues related to merging the standards are of legitimate concern to some suppliers. One of these issues is related to testing methods, i.e., one set of testing methods doesn’t fit all real-world needs. “In my opinion, a major issue is that testing methods related to the practical use of components should be an important part of certification, rather than theoretical,” states GEA’s Tolle. “This change would be well received by suppliers.”

SEEPEX’s Dillon is onboard with Tolle. “I think there is a fundamental difference between EHEDG and 3-A. EHEDG wants to rely on specifications and verification. I do not think the EHEDG testing applies to real-world situations.” Dillon cites his previously mentioned comparison between high-acid products and viscous dairy products where cleaning requirements are quite different. “A set testing regime will result in artificially high costs for some American producers, making them less competitive against foreign counterparts that are not subject to the level of inspections we have in the US.”

Despite the similarities and differences of 3-A SSI and EHEDG, a lasting marriage of the two might produce a more complementary pair—like yin and yang—as opposed to a single, monolithic set of rules. “The goal of both organizations is the promotion of hygienic design principles to be utilized throughout the food industry to assure the production of safe and wholesome foods wherever they are produced,” says Schonrock. “But their documents are quite different in approach and presentation. 3-A publishes standards for individual equipment types and approved practices for specified systems, whereas EHEDG publishes guidelines for the use of hygienic designs in equipment and processing. While the two types of documents do not lend themselves to combination, the basic hygienic principles espoused by both are the same. This uniformity of basic hygienic principles is the goal of the organizations. The types of documents published are complementary and not intended to replace each other. We believe this provides the greatest benefit to the documents’ users.”

Benefits of harmonization

While harmonization will certainly help improve food safety around the world, EHEDG’s Lorenzen notes the rules of each geographic location still apply. “Specifications for machinery to produce food for North America will follow 3-A regulations, while the specifications for machinery to produce food in Europe or to be imported into Europe will follow EHEDG guiding documents. This is accepted practice for all global food manufacturers.”

However, both standards promote hygienic design (HD), and Lorenzen points out some major benefits, which may not be obvious. He compares the latest state-of-the-art HD vs. T-piece designs that use hygienically risky components. His research found that non-hygienic legacy designs are responsible for up to 20 percent of the failures to meet GMPs. HD saves on operating costs by shortening cleaning time; increasing productive time; reducing chemicals and additives; decreasing power, steam and fuel consumption; and reducing water and water treatment costs.

Finally, education is the best product of harmonization. “I think one area that hasn’t been sufficiently mentioned is the educational efforts of both agencies,” says Schonrock. “3-A and EHEDG are organized under US and European law respectively as not-for-profit organizations with a large commitment to training and education. EHEDG has a long-standing commitment to training and developing training materials. 3-A SSI is also developing training modules that can be used throughout the food industry and to encourage young people to enter the field of hygienic design. Once again, the organizations harmonize the message that is in the training efforts.”

Resources:

“Sanitary Design: Guide for Sanitary Construction,” METTLER TOLEDO white paper, www.mt.com/pi-sanitary-design.

“EHEDG guidelines and Harmonization of EHEDG guidelines and 3-A standards,” www.ehedg.org/?nr=9.

3-A SSI website, www.3-a.org.

For more information:

Timothy Rugh, 3-A SSI, 703-790-0295, trugh@3-a.org, www.3-a.org

Knuth Lorenzen, EHEDG, +49 4173 8364, knuth.lorenzen@ewetel.net, www.ehedg.org

Tracy Schonrock, consultant, ftracy1@cox.net

Bastian Tolle, GEA, +49 (0) 211-9136-0, info@gea.com, www.gea.com

Andre Brandon, NGI, 312-596-1225, ab@ngi-usa.com, www.ngi-usa.com

Steve Blackowiak, Bühler Aeroglide, 919-851-2000, steve.blackowiak@buhlergroup.com, www. buhlergroup.com

Mike Dillon, SEEPEX, 937-864-7150, mdillon@seepex.com, www.seepex.com