Sanitary Design Connections - Fall 2019

Sanitary Design Connections - Fall 2019

Contributed by Gabriel Miller, Pi-FS, LLC

Sep 2019

“We meet 3-A Sanitary Standards” – How often have equipment suppliers made this claim without actually holding a 3-A Symbol authorization?

There is no regulatory requirement to purchase equipment with a 3-A Symbol; however, equipment that conforms to the 3-A Sanitary Standards complies with the Pasteurized Milk Ordinance (PMO) under the following PMO clause:

“Equipment manufactured in conformity with 3-A Sanitary Standards and Accepted Practices complies with the sanitary design and construction standards of this Ordinance. For equipment not displaying the 3-A Symbol, the 3-A Sanitary Standards and Accepted Practices may be used by Regulatory Agencies as guidance in determining compliance with this Section.”

Considering the budget limitations of the Federal and State regulatory agencies and the demands put on them, they often do not have the time, resources, or expertise to thoroughly inspect all the equipment installed in dairy plants. Additionally, the material certifications for the materials of construction, especially rubber and plastic components, are extremely difficult, if not impossible, to obtain after shipment. Therefore, the best assurance that equipment has been designed and fabricated in accordance with the 3-A Sanitary Standards, and that it complies with the PMO, is to purchase equipment that bears the 3-A Symbol.

Recently, a company was installing new equipment in a dairy processing plant, and the State regulatory inspector required that it meet the 3-A Sanitary Standards prior to start-up. The only way to verify that the equipment actually conformed to the standards was to conduct an on-site inspection by a 3-A Certified Conformance Evaluator (CCE).

On initial appearance, the equipment seemed to meet the standards, but on closer inspection, there were some design and fabrication flaws that could have easily become a source of microbial contamination. The crevices in the following photos could not be cleaned, and would have become hidden bacteria harborage points directly in the product zone.

Crevice in incomplete weld
Non-sanitary weld with crevices
Sprayball with crevice in the inlet connection

Corrective action of the above non-sanitary components was very costly to the equipment supplier, and delayed the project start- up by several months.

In another application, an ice cream processor purchased a mixing tank that was purported to meet the regulations. Externally, the tank was highly polished, and appeared to conform to the 3-A Sanitary Standards, but on closer inspection, there were many features that did not conform. The mixer had already been purchased, but it could not be used for processing a dairy product.

Agitator with exposed shaft for leak detection
Crevice in agitator shaft
Corrosion / non-sanitary welds
Crevices / threaded bolts

This mixer should have been specified initially with a 3-A Symbol, and should never have been accepted without verification that it conformed to the 3-A Sanitary Standards.

The 3-A Third Party Verification (TPV) inspection process, required before a 3-A Symbol can be applied, is not an inspection of every piece of equipment. However, it does verify that the equipment fabricator has a quality assurance process and procedures in place to ensure that all equipment supplied with the 3-A Symbol will conform with the requirements of the 3-A Sanitary Standards. It is thus a stamp of assurance to the local, state, and federal regulatory inspectors that the equipment will comply with the PMO, without further detailed inspection or scrutiny.

During the TPV inspection, the 3-A CCE verifies the fabricator’s quality program, material certifications, weld quality, surface finish, corner radii, cleaning method, drainability, access for inspection, and other sanitary design features. They also verify that there are no crevices, hidden cavities, dead legs, or non-sanitary threads in product contact. The fabricator must maintain an Engineering Design and Technical Construction File (EDTCF), with documents available for a period of 12 years after the equipment is shipped for traceability.

After the equipment is delivered, it is the responsibility of the dairy processor or their installation contractor to install the equipment in accordance with the fabricator’s instructions and with the 3-A Accepted Practices to ensure that it can be operated in a sanitary manner.

These 3-A Accepted Practices include process and CIP piping installation, compressed air quality, spray drying, culinary steam, and membrane filtrations systems, as applicable to each process application.

Additionally, there is a 3-A Replacement Parts and System Component Quality Certification (RPSCQC) program in place to verify the conformance of replacement components for process equipment. When processors purchase replacement components, this certificate ensures that the parts meet the same sanitary requirements as the original equipment.

The 3-A SSI web site provides a list of all equipment fabricators that hold 3-A Symbol authorization and other certificates. This resource can be incredibly helpful for design engineers or purchasing agents when specifying and purchasing equipment. Purchasing equipment with a 3-A Symbol is the best method to ensure that it will be of a sanitary design and fabricated with non-toxic materials, and that it will meet the regulatory requirements for dairy processors.

You can find information on obtaining 3-A Sanitary Standards and 3-A Symbol-authorized equipment at

PH 703.790.0295   |   FX 703.761.6284