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Glossary

1

1.4401

DIN Werkstoffe number 1.4401 (DIN 17006)
Stainless steel grade equivalent to 316

1.4404

DIN Werkstoffe number 1.4404 (DIN 17006)
Stainless steel grade equivalent to 316L, with lower percentage Nickel than 1.4435 (X2CrNiMo17-12-2)

1.4435

DIN Werkstoffe number 1.4435 (DIN 17006)
Stainless steel grade equivalent to 316L, with higher percentage Nickel than 1.4404 (X2CrNiMo18-14-3)

2

2.1

Declaration of compliance with the order 2.1 - EN 10204:2004
With the type 2.1, declaration of compliance with the order, document 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

2.2

Test report 2.2 - EN 10204:2004
With the type 2.2 test report document, 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.

3

3.1

Inspection certificate 3.1 - EN 10204:2004
With the type 3.1, inspection certificate producers declares that the products are in accordance with the order. The relevant test results and chemical analysis results are presented in this document.

3.2

Inspection certificate 3.2 - EN 10204:2004
In the type 3.2 inspection certificate both the producer and either an inspector authorised by the customer or designated by the official regulations certify that the products are in accordance with the order.

304

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.

316

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.

316L

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 suited to use in  welded components.

3A

3-A Sanitary Standards
An independent, not-for-profit corporation dedicated to advancing hygienic equipment design for the food, beverage, and pharmaceutical industries.

9

904L

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.

A

Alloy 22

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.

ASME

American Society of Mechanical Engineers
Creates consensus standards for Mechanical Engineering

ASTM

American Society for the Testing of Materials
Creates consensus standards for material quality and material quality testing methods.

ATEX

Atmosphere Explosive.
An abbreviation that is used in conneetion 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.

B

BS 4825-3

BS 4825-3
Stainless steel tubes and fittings for the food inductry and other hygienic applications, British Standards

C

CEN

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.

CF3M

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

CF8M

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

CGMP

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.

CIP

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

D

DIN

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

DIW

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

E

EHEDG

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.

EP

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

EP or E/P

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

EPDM

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.

F

FDA

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.

FKM

Fluoroelastomer
FKM is the short form for the fluoroelastomer category according to the American standard ASTM.

G

Gylon

Gylon
Modified and restructured PTFE material. Trademark of Garlock.

I

ISO

International Standards Organization
Creates consensus standards for engineering and quality systems.

M

MTR

Mill Test Report or Material Test Report
A Mill Test Report (MTR) is a quality assurance document used in the metals industry that certifies a material's chemical and physical properties and states a product made of metal (steel, aluminum, brass or other alloys) compliance with an international standards organization (such as ANSI, ASME, etc.) specific standards.

P

P&ID

Piping and Instrumentation Diagram
American standard for process diagrams. Diagrams on which the process, the instruments and the flow scheme are defined.

Peek

Polyether ether ketone
PEEK is a semicrystalline thermoplastic with excellent mechanical and chemical resistance properties that are retained to high temperatures.

Platinum Cured Silicone

Platinum Cured Silicone
Silicone rubbers have good resistance to hot air. They are unaffected by sunlight and ozone. The temperature range would be between -54°C to 260°C

POU

Point of Use
A valve outlet in a recirculation utility system (typically a water system).

PTFE

PolyTetraFluoroEthylene
PTFE is the material of choice whenever low temperature flexibility or hygienic seal memory is not required (not recommended where large temperature variations occur frequently, leakage can occur). PTFE has almost no extractables, has a low absorption rate and excellent resistance to process fluids.

PW

Purified Water
Ingredient water (not for injection) or rinse water for pharmaceutical products conforming to USP guidelines. Obtained by distillation, reverse osmosis, ion exchange or any other suitable process.

S

Schedule

ANSI B36.19
For the purpose of standardizing pipe dimensions, the American National Standards Institute (ANSI) published ANSI B36.19. That standard broadened the range of wall thicknesses, schedule numbers from Schedule 5S through schedule 80S. The addition of the letter “S” after the schedule number identified it as pertaining to stainless steel.

SIP

Steam in Place
Sanitization of process line components by the use of steam without the need for relocation or disassembly.

SMS 3008

SMS 3008, EN10357 Serie D
Seamless and welded stainless steel hygienic tubing, Swedish Standards

T

TFM 1600

TFM 1600 is a second-generation modified PTFE
TFM 1600 is a modified PTFE that maintains the exceptional chemical and heat resistance properties of PTFE, but has a significantly lower melt viscosity. Features reduced cold flow, lower porosity and permeability, and lower void content.

TOC

Total Oxidizable Carbon or Total Organic Carbon
A measure of the amount of organic compounds in a water sample. Carbon is oxidized and the level of CO2 is measured. The proposed USP water standards are based on TOC analysis.

Tuf-flex

Gasket with a layer of PTFE unitized to an EPDM core
This totally bonded construction provides a PTFE gasket with the mechanical characteristics, including memory, of an elastomer gasket. Designed to meet critical requirements in biopharmaceutical, ultra-pure water, WFI (water for injection) and difficult food and beverage processing,

Tuf-steel

A 50/50 blend of nonpigmented PTFE and 316L
Tuf-Steel is the choice for leak-proof, perfect surface performance and outstanding durability in SIP (steam in place) and WFI (water for injection) applications. Tuf-Steel is ideal for sanitary steam pipe connections in extreme temperatures ranging from -75°C to 260°C.

U

USP

U.S. Pharmacopeial Convention
A scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide.

V

Viton

Fluoroelastomer (FKM)
Viton is a registered trademark of DuPont Performance Elastomers L.L.C.

W

WFI

Water for Injection
Water for use as a solvent for the preparation of parenteral products conforming to USP guidelines. Obtained most commonly by distillation.