Sanitary Design Connections - Fall 2021

Sanitary Design Connections - Fall 2021

Aug 2021

A Holistic Approach to Implementing a Hygienic Design Plan

Contributed by Larry Hanson, CIP Concepts

Hygienic design for food processing facilities commonly focuses on new equipment and new facility construction. The selection of proper materials of construction, surface finishes, radii, welding quality and other parameters critical for good hygienic design. A broader holistic approach looks beyond design to include internal programs, policies, installation, cleaning, maintenance, and operational factors to achieve hygiene integrity.

A food manufacturing company’s holistic plan should include all policies and programs that affect the cleanability and inspectability of the process and facility during its useful life. A company’s written policies and program should provide requirements, guidelines, training and resources for maintaining the hygienic conditions to produce safe food. First, the company must understand and comply to all applicable food safety laws and regulations and monitor for changes in the current regulations.

A written corporate hygienic design specification provides the foundation for procurement and installation of all new and used equipment. This specification may reference current hygienic design standards like 3-A SSI, BISSC and EHEDG. Pre-fabrication design reviews should be conducted prior to equipment fabrication. Fabricators should be audited to assure the fabrication facility and methods can deliver food safe equipment.

Facility designs should be continuously reviewed for changes in the physical structure of the building. Monitoring for changes in traffic flow of people, equipment, products, and ingredients that could cross-contaminate and create food safety risks. Air handling systems, potable water supply and product contact air need to be periodically tested to assure for hygienic conditions. Roof leaks should be repaired immediately. A facility pest control program needs to be in place and managed by a licensed pest control professional.

Written cleaning and sanitizing protocols must be used and validated for all equipment and areas of the facilities. These protocols include recommended cleaners and sanitizers to use, cleaning methods, tools required, frequency of cleaning and detail cleaning steps. Periodic training and training refreshers are required for all sanitation personnel.

Maintenance personnel must be trained in hygienic design to assure the plant and all its equipment are maintained in a hygienic condition. They must understand the need for repairs with noncorrosive metals, proper finish and the requirements for FDA approved elastomers. Operational GMPs (good manufacturing procedures) and quality control protocols must be followed during the entire production and packaging process.

A holistic approach to hygienic design will provide a food processing plant with a plan that meets the hygienic requirements to produce safe food.

3-A SSI Sets On-site 2022 Education Program

3-A SSI announces plans to hold its yearly education program and annual meeting on-site at the Hilton Minneapolis/St. Paul Airport Hotel in Bloomington, MN on May 16-19, 2022. The program will feature experts on a range of leading topics and issues in the hygienic design of food processing equipment.

The 2022 education events will open with a comprehensive introductory and networking session on Monday, May 16. 3-A SSI for Beginners and the Basics of Sanitary Design will be a fast-moving full-day program, beginning with an overview to 3-A SSI and an introduction to the elements of hygienic equipment design that distinguish 3-A Sanitary Standards. This session will be oriented to early career professionals and others who seek an understanding of the fundamentals of hygienic design and the role of 3-A Sanitary Standards.

The second day, May 17, will feature a full day of leading experts and timely topics reflecting the current developments, future challenges and new opportunities for hygienic design. The program will highlight the key challenges to enhancing food safety equipment and systems from the standpoint of regulatory professionals, equipment users (processors) and equipment fabricators.

The 3-A SSI Annual Meeting will open on Wednesday morning, May 18, with reports on 3-A SSI programs and services. Work Group sessions will begin Wednesday morning and continue through Thursday afternoon, May 19. More details on the program and related events will be announced this fall. For general information, contact Timothy Rugh at 3-A SSI.

Busy Summer for Revised 3-A SSI Standards

3-A SSI recently announced the release of two more equipment standards revised to reference the 3-A Sanitary Standard for General Requirements, ANSI/3-A 00-01-2018 as a major normative reference.

3-A Sanitary Standard for Homogenizers and Reciprocating Pumps, Number 04-06 applies to the sanitary aspects of homogenizers and reciprocating pumps, and their integral ancillary components, for liquid products. Product enters the homogenizer or reciprocating pump at the product inlet and exits at the product outlet. This 3-A Sanitary Standard does not include drum-type pumps.

3-A Sanitary Standard for Tubular Heat Exchangers, Number 12-08 applies to the sanitary aspects of tubular heat exchangers without agitators. Product enters at the product inlet(s) and exits at the product outlet(s). Both standards become effective on June 5, 2021.

Other new releases include:

The 6th edition of the widely-used 3-A Accepted Practice for Installation and CIP (Clean-In-Place) of Processing Equipment and Hygienic Pipelines, Number 605-05. The new edition is compatible with FDA’s ‘Grade A’ Pasteurized Milk Ordinance and also contains requirements for non-PMO food processing applications. The revised Practice incorporates provisions of 3-A Sanitary Standard for General Requirements, ANSI/3-A 00-01-2018 as a normative reference. The revised edition is effective on July 5, 2021. This Practice establishes criteria for the installation of hygienic pipelines, installation of processing equipment intended for CIP, CIP Systems used for cleaning and sanitizing hygienic pipelines and processing equipment including Process Incorporated (Self-Contained) CIP Systems and CIP procedures. The CIP System begins after the shut-off valves for water, cleaning and sanitizing chemicals, and utilities, and ends at the drain connection where CIP effluent exits. Criteria for the CIP cleaning and sanitizing of individual items of equipment may be found in the 3-A Sanitary Standards covering the specific equipment. This Practice does not apply to cleaning systems used on dairy farms that operate under vacuum nor to piping, ductwork, and process equipment designed to be cleaned by dry cleaning methods. Facilities that utilize a CIP system conforming to this Accepted Practice may be eligible for a Process Certificate from 3-A SSI. For more information about a Process Certificate, see the application requirements and instructions found in the TPV Manual at www.3-a. org.

The 8th revision of the widely used 3-A Sanitary Standard for Compression-Type Valves, Number 53-07. Effective on July 10, 2021, this revision includes adoption of the “B Level” Format and Style with normative reference to the ANSI/3-A 00-01-2018, 3-A Sanitary Standard for General Requirements (GR). When last revised in 2009, the only updates to 53-06 were made in the requirement for allowance of a “plastic compression-type valve plug” and that “valves may be a plastic material to metal seat.” This followed a quick update in 53-05 to add clarification to its requirements that “where a valve stem penetrates the valve body, the stem seal may be mounted in the valve body or on the valve stem.” The addition of the word “valve” in that clause and requested illustrations were the only major updates post 53- 04. Clarity of the concept and word choice cannot be understated when it comes to understanding and applying public health safety standards and sometimes it can take years and many different ways of thinking about these concepts and how differently one can interpret those words and concepts. New contributors come into the standardization effort and in short standards are organic and technologies change. These plastic allowances are still in effect and now in latest edition, 53-07, plus many additions to the list of plastic allowances and clarity for use of enclosed threads “for valve stems and valve plug to stem assembly” with further mandatory requirements referenced in the GR. 53-07 “applies to the sanitary aspects of compression-type valves used on processing equipment and on equipment and lines which hold or convey fluid products. Product enters the inlet(s) and exits the outlet(s) of the valve and when used includes the actuator.”

Under provisions of the TPV program for 3-A Symbol authorization, symbol holders must maintain a copy of the latest standard. 3-A Symbol holders should contact their Certified Conformance Evaluator (CCE) to request an amendment report to show conformance to the new edition of any equipment standard. All Standards and Accepted Practices are available for purchase in electronic or hard copy at the 3-A SSI eStore at under ‘Standards & Accepted Practices Store’. 3-A SSI maintains over 80 individual food processing equipment standards and 10 accepted practices for food processing systems. A large number have been upgraded to the new format but many other revisions are underway in this multi-year project. 3-A SSI invites all interested stakeholders to join the 3-A SSI Working Group(s) of interest. Visit our Working Group webpage for more information or contact Eric Schweitzer at

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