ROMYNOX Glossary

DIN Werkstoffe number 1.4401 (DIN 17006)

Stainless steel grade equivalent to 316.

DIN Werkstoffe number 1.4404 (DIN 17006)

Stainless steel grade equivalent to 316L, with lower Nickel percentage than 1.4435 (X2CrNiMo17-12-2).

DIN Werkstoffe number 1.4435 (DIN 17006)

Stainless steel grade equivalent to 316L, with higher Nickel percentage than 1.4404 (X2CrNiMo18-14-3).

Declaration of compliance with the order 2.1 – EN 10204:2004

With the type 2.1, declaration of compliance with the order, the producer declares that the products are in accordance with the order. In this, the charge number of the products is given but neither the test report nor chemical analysis are announced.

Test report 2.2 – EN 10204:2004

With the type 2.2 test report document, the producer declares that the products are in accordance with the order. In the test report the quality control test results based on non- specific inspection are given, in accordance with the general material standards. The test results are not necessarily those from the lot supplied to the customer.

Inspection certificate 3.1 – EN 10204:2004

With the type 3.1, inspection certificate producers declare that the products are in accordance with the order. The relevant test results and chemical analysis results are presented in this document.

Inspection certificate 3.2 – EN 10204:2004

On the type 3.2 inspection certificate both the producer and an inspector either authorised by the customer or designated by the official regulations certify, that the products are in accordance with the order.

Stainless Steel 304 (AISI)

304 stainless steel is the most common stainless steel. The steel contains both chromium (usually 18%) and nickel (usually 8%) metals as the main non-iron constituents. It is an austenite steel. It is not very electrically or thermally conductive, and is non-magnetic. It has a higher corrosion resistance than regular steel and is widely used because of the ease in which it is formed into various shapes.

Stainless Steel 316 (AISI)

Type 316—the second most common grade (after 304); alloy addition of molybdenum prevents specific forms of corrosion. It is also known for its increased resistance to chloride corrosion compared to type 304.

Stainless Steel 316L (AISI)

Type 316L—is an extra low carbon grade of 316, generally used in the fabrication of pressure vessels for boiling water reactors, due to its high resistance to corrosion. It is immune to grain boundary carbide precipitation. This makes it suitable to use in  welded components.

3-A Sanitary Standards

An independent, non-profit corporation dedicated to advancing hygienic equipment design for the food, beverage, and pharmaceutical industries.

UNS NO8904

Alloy 904L is a low carbon high alloy austenitic stainless steel which is widely used in applications where the corrosion properties of AISI 316L are not adequate. The addition of copper to this grade gives it corrosion resistant properties superior to the conventional chrome nickel stainless steels, in particular to sulphuric, phosphoric and acetic acids. It also has a high resistance to pitting in chloride solutions, a high resistance to both crevice and stress corrosion cracking.

Acrylicnitrile-butadiene-styrene

A thermoplastic resin with an excellent resistance to acids, bases, salts and some solvents. It is heat-resistant to 80°C.

Animal Derived Component Free (Animal Derived Ingredient free)

Materials and components that are used during processing and transfer are free of animal-derived ingredients.

Hastelloy Alloy 22

The predominant alloying ingredient is nickel. The primary function of the Hastelloy super alloys is that of effective survival under high-temperature, high-stress service in a moderately to severely corrosive, and/or erosion-prone environment, including the pressure vessels, chemical reactors, distillation equipment, and pipes and valves in chemical industry.

American National Standards Institute, Inc.

ANSI is the primary organization for fostering the development of technology standards in the United States.

Leakage Rates pressure relief valves

API Standard 527, from the American Petroleum Institute, describes seat tightness testing and the maximum acceptable leakage rates for pressure relief valves.

American Society of Mechanical Engineers

Creates consensus standards for Mechanical Engineering.

American Society for the Testing of Materials

Creates consensus standards for material quality and material quality testing methods.

Atmosphere Explosive

An abbreviation that is used in connection with two European Directives conceming production of equipment and safety systems for use in potentially explosive atmospheres and safety for personnel working in potentially explosive atmospheres.

For Sterilization

Autoclaving is a sterilization method that uses high-pressure steam. The autoclaving process works by the concept that the boiling point of water (or steam) increases when it is under pressure. Autoclaves can be used to eliminate microorganisms.

Welding with equipment that performs the welding operation without adjustment of the controls by a welding operator.

BioPhorum Operations Group

BPOG is a consortium of biopharmaceutical manufacturers and represents over 30 companies, which among others published a paper in Pharmaceutical Engineering titled “Standardized extractables testing protocol for single-use systems in biomanufacturing.”

BS 4825-3 standard

Stainless steel tubes and fittings for the food inductry and other hygienic applications, British Standards.

Nitrile rubber, also known as Buna-N

Synthetic rubber, a copolymer of acrylonitrile and butadiene. This form of synthetic rubber is unusual in being generally resistant to oil, fuel, and other chemicals.

A common mechanical seal face material chemically inert to most fluids with the exception of oxidizers, bleaches, halogens and a few other fluids.

Comite Européen de Normalisation

Committee for European Standardization. Creates standards that reflect the best practices in each industry and is supported by DIN and ISO.

Stainless Steel CF3M

CF3M is the cast equivalent of Type 316L (S31603). CF3M castings have good machining and welding characteristics.

Stainless Steel CF8M

CF8M is the cast equivalent of Type 316 (S31600). It is readily weldable and is not hardenable by heat treatment.

Current Good Manufacturing Practices

Current design and operating practices developed by the pharmaceutical industry to meet FDA requirements as published in the Code of Federal Regulations. They reflect the least common denominator of practices in the industry at present.

Clean in Place

The technique of cleaning process line components without the need for relocation or disassembly.

The Cv-value is a parameter defining the flow rate of valves. It describes the amount of water from 5° to 30°C which flows through the valve at a pressure loss of 1 bar. In some countries they use the Cv-value, they are related as Cv = 1.156*Kv.

Double-Acting

Any pneumatic actuator, which uses air to drive the actuator, output shaft in both the CW and CCW directions. The air supply is piped to one side of a piston-drive or a diaphragm while the air contained on the opposing side is exhausted.

A space where the system design and operating conditions result in insufficient process fluid flow, presenting a risk for particulate, chemical, or biological contamination.

Deutsches Institut für Normung

German Institute for Standardization. Creates engineering standards for Germany and is contributing body to CEN and ISO.

Deionized Water

Process of the extraction of deionized water through ion exchange resins.

European Hygienic Equipment Design Group

The group’s objective is to provide standardization organizations (CEN and ISO) with specialist views on hygienic and aseptic design by publishing requirements and test methods. Accredited bodies carry out cleaning tests which are certified if successful.

European Pharmacopoeia

European counterpart to USP. A private, non-profit organization that sets standards for drugs, drug ingredients, medical devices and diagnostics.

Electro-Polish

Electrochemical polishing process for metal components where metal ions are removed from the surface of the metal.

Ethylene Propylene Diene Monomer

This synthetic material has good resistance to strong acids, alkalies, salts and chlorine solutions. Its temperature range would be between -57°C to 177°C.

Electron Spectroscopy for Chemical Analysis

A procedure that uses electron beams to characterize the extreme outer surface of a metal. Typically used to determine levels of chromium oxide on the surface of austenitic stainless steel.

Ethylene Oxide

Ethylene oxide is one of the most commonly used sterilization methods in the healthcare industry because of its non-damaging effects for delicate instruments and devices that require sterilization, and for its wide range of material compatibility.

Ethylene Vinyl Acetate

Ethylene Vinyl Acetate Co-Polymer (EVA) is a copolymer of Ethylene and Vinyl Acetate. It is an extremely elastic and tough thermoplastic of excellent clarity and gloss and with little odor. The product has many attractive properties including excellent adhesion to polar and nonporous substrates, good flex-crack and puncture resistance, as well as good hot-tack and heat-sealing.

Leachables & Extractables

An extractable is a chemical entity, both organic and inorganic, that will extract from the components of a process system into a solvent under controlled conditions (usually extreme conditions not encountered in a process). This means high heat, pressure, or even multiple sterilization cycles. It also mean strong acids and organic solvents.

U.S. Food and Drug Administration

A federal agency of the United States Department and is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[5] and veterinary products.

Fluorinated Ethylene Propylene

FEP is a tough, flexible copolymer of tetrafluoroethylene and hexafluoropropylene. It is often used for flexible tubing and fluid processing equipment when chemical resistance, high purity, and low stiffness are required.

Perfluoroelastomers

FFKM rubber compounds have excellent resistance to high temperatures and chemicals. Certain grades have a maximum continuous service temperature of 327 °C.

Fluoroelastomer

FKM is the short form for the fluoroelastomer category according to the American standard ASTM. Most known as Viton®.

Fluoroelastomer

FPM is the international abbreviation according to DIN/ISO. Most known as Viton®.

For Sterilization

Gamma Irradiation is the process of exposing various products to ionizing gamma rays (similar to UV and X-rays) in a highly controlled manner for a specific goal, such as elimination of virus, bacteria, and other undesirable organisms etc.

The ability to resist a change in physical properties under gamma irradiation. Typically gamma irradiation is used in the plastics industry to sterilize tubing or process components in an aseptic container. Commonly acceptable doses range between 25 kGy and 55 kGy

Modified and restructured PTFE material. Trademark of Garlock (Rubber Fab).

High Efficiency Particulate Air Filter

A type of air filter that removes 99.97% of particles 0.3µ and larger in diameter.

The volume of liquid remaining in a vessel or piping system after it has been allowed to drain.

A tube outside diameter union consisting of two neutered ferrules having flat faces with a concentric groove and mating gasket that is secured with a clamp, providing a non-protruding, recessless product contact surface.

Thermoplastic Elastomer Engineered for Versatile Performance

DuPontTM Hytrel® TPC-ET thermoplastic elastomer is a versatile copolyester. It combines resilience, and heat and chemical resistance with strength and durability.

International Society for Pharmaceutical Engineering

A global not-for-profit membership organization that provides education, training and technical publications to pharmaceutical manufacturing professionals

International Standards Organization

Creates consensus standards for engineering and quality systems.

Cleanroom ISO class 1-9

Cleanroom classifications based on air particulate concentration as defined by the International Organization for Standardization, see page 306 for more information.

Safety devices for protection against excessive pressure

This European Standard specifies general requirements for safety valves irrespective of the fluid for which they are designed.

International standard for valve and actuator interface.

Polyarylamide (PARA or PAA)

Ixef® compounds typically contain 50-60% glass fiber reinforcement, giving them remarkable strength and rigidity. Ixef® is a registered trademark of Solvay

Perfluoroelastomers (FFKM)

Kalrez is the registered trademark of DuPont Performance Elastomers L.L.C.

The Kv-value is a parameter defining the flow rate of valves. It describes the amount of water from 5° to 30°C which flows through the valve at a pressure loss of 1 bar. In some countries they use the Cv-value, they are related as Cv = 1.156*Kv.

PVDF (polyvinylidene fluoride)

A trade mark of Arkema Chemical Corp. Kynar^® tubing is an economic alternative to PTFE tubing.