3-A Sanitary Standards and Accepted Practices
Criteria for cleanability of dairy processing equipment. They have been adopted by many other liquid processing industries outside of dairy. They are written as a co-operative effort between users, equipment manufacturers, sanitarians and regulatory agencies. The “3 Associations” are the International Association of Milk, Food and Environmental Sanitarians; the U.S. Public Health Service; and the Dairy Industry Committee.
Activated Carbon Bed (AC)
A filtration method for the pre-treatment of water to remove residual chlorine and organic material. Water is passed through a deep bed of granular activated carbon (GAC) at low flow rate (see GAC).
A negatively charged ion.
A treatment process for steel for the purpose of reducing hardness, improving machinability, facilitating cold working, or producing a desired mechanical, physical, or other property.
A localized surface area that is out of specifications to the surrounding area, and is classified as abnormal.
A discontinuity consisting of any localized remelted metal, heat-affected metal, or change in the surface profile of any part of a weld or bas metal resulting from an arc.
Free of pathogenic (causing or capable of causing disease) microorganisms.
Operating in a manner that prevents contamination of the process.
American Society of Mechanical Engineers (ASME)
Creates consensus standards for Mechanical Engineering.
(Pronounced O-JAY). A process for analyzing the composition of metal as a function of surface depth. The surface composition is determined as successive layers are removed by vaporizing the metal with an electron beam. Used to determine the level of chromium-oxide on the surface of austenitic stainless steel.
A piece of equipment used for steam sterilizing components “out of place”. In other words, parts must be placed into the autoclave for sterilization. “Autoclaving” can also refer to the process of using an autoclave. NOTE: a component designed for SIP cannot necessarily be autoclaved!
A weld made by fusion of the base material without the addition of filler (see gas tungsten arc welding).
A layer of trace organic material that can adhere to the interior wall of process line components.
Therapeutic or diagnostic products generated and purified from natural sources.
Ethical pharmaceutical drugs derived through bioprocessing.
The creation of a product utilizing a living organism.
Equipment, systems, or facilities used in the creation of products utilizing living organisms.
Bio Processing Equipment (BPE)
ee of ASME, it creates engineering standards the design, specification, manufacture, and documentation for equipment used for BioPharma processes.
A discontinuity in the face of a fitting.
Excessive melt-through or a hole through the root bead.
Excess material protruding from the edge resulting from cutting
A joint between two members lying approximately in the same plane.
A condition of liquid flow where, after vaporization of the liquid, the subsequent collapse of vapor bubbles can produce surface damage.
Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable.
Colony Forming Unit (CFU)
A measure of bacterial contamination. Samples are incubated in a growth media (see PCA) and the resulting colonies are counted, each colony is assumed to have been derived from one bacterium.
Comite Europeen de Normalisation (CEN Committee for European Standardization)
Comprised of the 13 national standards organizations in Europe, Creates standards that reflect the best practices in each industry. Used to aid in the application of the directives of the European Commission.
Measurement of a substances ability to conduct an electric current. Measured in µ- mhos/cm, or µ-siemens/cm. Used as a measurement for the purity of water.
Current Good Manufacturing Practices (cGMP)
Written and enforced by the FDA. Consists of some specific, but mostly “umbrella” regulations covering personnel, records, and equipment, leaving much to the interpretation of the Inspector and court system. CGMPs are evolutionary, reflecting the least common denominator of practices in the industry at present (hence the term “current”).
The purification of substances based on the chemical, physical, and biological properties of the molecules involved.
Free of dirt, residues, detergents, or any contaminants that may affect or adulterate the product or process.
Clean in Place (CIP)
The process of cleaning process line components without disassembly.
Steam free from boiler additives that may be purified, filtered, or separated. Usually used for incidental heating in pharmaceutical applications.
The appearance of a milky white hue across some portion of a surface resulting from the electropolish process.
Porosity that occurs in clumps or clusters.
Commission of European Communities (EEE/EC)
Legislative and enforcement body of the European Union. Uses CEN standards to assist in the application of its directives.
A condition in which the surface of a welded joint is depressed relative to the surface of the tube or pipe. Concavity is measured as a maximum distance from the outside or inside diameter surface of a welded joint along a line perpendicular to a line joining the weld toes.
A ring of metal placed between the two elements to be welded that provide filler for the weld, when performed with fusion welding equipment. A consumable insert can also be usedLS