Industry Terms and Definitions
Industry Terms and definitions makes the sanitary sealing world easier to understand
Abrasion – The process of scarping or wearing away material.
Active Coating – A coating that contains active ingredients. (APIs)
API – Active Pharmaceutical Ingredients (see also active ingredients) or active- is the part of a pharmaceutical drug that is biologically active. This is the ingredient that triggers the desired pharmacological reaction in a patient’s body. To formulate a dosage form (e.g. tablet) that could be efficiently produced and delivered to the body some inactive ingredients (see also excipient) are often added to the formulation. Most commercial dosage forms typically consist of both API(s) and excipients.
ASME BPE – The American Society of Mechanical Engineers Bio Processing Equipment (ASME BPE) standardizes specifications for the design, manufacture, installation, inspection and acceptance of equipment used in the pharmaceutical and biological products industries.
ASME BPVC Section IX – The American Society of Mechanical Engineers Boiler Pressure and Vessel Code. Section IX defines welding procedures and how the procedures and welders are qualified.
Autogeneous Welding – A fusion welding process using heat without the addition of filler metal to join two pieces of the same metal.
Biopharmaceutical – A pharmaceutical derived from biological sources and especially one produced by biotechnology. A therapeutic product created through the genetic manipulation of living things, including (but not limited to) proteins and monoclonal antibodies, peptides, and other molecules that are not chemically synthesized along with gene therapies, call therapies, cell therapies and engineered tissues.
Batch – The amount of product being processed at hand. Batches can be processed either individually (single batch) or continuously (continuous batch).
Batch Record – Documents prepared for each process batch which include all ingredients, process details and equipment used to make the product. Manufacturers of regulated drug products are also required to prepare a master batch record. An approved master batch records the source document for all individual batch records, which are prepared and executed each time a new batch of the given product is manufactured.
Bevel Seat – A type of sanitary fitting incorporating a 45° beveled sealing surface
Braided Cover – Three or more strands of flexible material interlaced to form a length; used to cover a hose for abrasion and chemical-resistance
cGMP – Current Good Manufacturing Practices. Good Manufacturing Practice guidelines (GMPs) are published by the FDA and are used by pharmaceutical, medical devise, and food manufacturers as they produce and test products that people use.
Change Control Record – A record which documents any changes made to the master batch for the manufacture of a product. The change must be supported, documented and approved by management personnel responsible for the manufacture and release of the product to the public.
Extrusion – The process of a material being pushed or drawn through a die of a desired cross-section.
FDA Rubber Hose – a hose made of rubber that is designed to transport fluids without imparting odor or taste, and designed for sanitary suctions and discharge that is specifically designed to meet FDA requirements for sanitary use.
Formulation – A mixture of structures prepared according to a specific procedure (“formula”).
Full Penetration – Describes the type of weld where in the weld metal extends through the complete thickness of the parts being joined.
Functional Coating – See Modified Release Coating.
Gasket – a shaped piece or ring of rubber, or other material, sealing the junction between two surfaces in an engine or other device.
Hose Fitting – a small part (or fitting) that is used to connect a hose to another component.
HPC – Hydroxpropyl cellulose, a type of coating polymer.
HPMC – Hydroxypropyl methylcellulose, an early- and still commonly used-tablet coating material. In modern coating systems (formulation), additional substances are added to it as plasticizers, anti-tacking agents, etc. but it still remains a main component of many coatings. It is used in many complete coating systems, for instance Opadry® by Colorcon®.
Installation Qualification (IQ) – Documents which establish that the critical components of a system are installed correctly and in accordance with the design documentation requirements (i.e. specifications, purchase orders, contracts, bid packages, etc).
Modified Release Coating – Film coatings applied to the solid dose form (tablet, bead, capsule) to alter the release of API in a dosage form after it is ingested. The drug release characteristics of time, course and/ or location (in the GI tract) are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms. Examples of modified release functionality could be: sustained release coating, enteric coating (see enteric coating).
MTR – Mill test report, a quality assurance document in the steel industry that certifies a material’s compliance with appropriate ASTM standards and applicable dimensions as well as physical and chemical specifications.
Non-Functional Coatings – (Also referred to as conventional coatings) film coatings applied to tablets for improved product appearance (color, gloss), improved handling (e.g. moisture and US protection), etc.
O-Ring – A gasket in the form of a ring with a circular cross section, used to seal connections in pipes, tubes, etc.
Operational Qualification (OQ) – Documents which establish, through testing, that all critical components and “direct impact” systems are capable of operating within established limits and tolerances.
Orbital Welding – Automatic or machine welding of tubes or pipe-in-place with the electrode rotating (or orbiting) around the work.
Orifice Plate – a thin plate with a hole, usually placed in a fluid pipe, most commonly used to measure flow rates
Passivation – The formation of the protective layer of nickel and chromium oxides that prevent the formation of iron oxide (rust). Stainless steel self-passivates when exposed to air. The process known as passivation is actually an acid cleaning process that removes surface contaminants and allow the stainless steel to form the integral passive layer when exposed to air. Passivation doesn’t change the appearance or surface finish.
Permeability – The quality or condition of a material allowing passage of fluid, gases or air through it
Potency – A measure of drug activity expressed in terms of the amount required to produce an effect of given intensity. A highly potent drug evokes a larger response at low concentrations, while a drug of lower potency evokes a small response at low concentrations.
Process Qualification (PQ) – Process qualification is the final qualification activity before process validation. PQ integrates procedures, personnel, systems and materials to verify that the given pharmaceutical grade utility, environment, equipment, or support system produces the required output.
PTFE – abbreviation of Polytetrafluoroethylene; a polymer with excellent chemical resistance noted for its slippery, non-sticking properties
PVA – Polyvinyl alcohol. Used in certain coating systems (complete coating formulations).
Quality Control – A process by which a given entity (e.g. the FDA) reviews the quality of all factors involved in production of a given drug, product or compound.
Quarantine – The compulsory isolation of a person, animal or substance, typically to contain the spread of something considered dangerous, often (but not always) disease.
Riboflavin Test – In cases of organic residues in vessels, a common practice is to spray the inner surfaces with a solution of riboflavin (vitamin B6) which adheres to the residue. When the surfaces of the vessel are exposed to UV light, adhering riboflavin fluoresces, indicating which areas need to be cleaned.
Rouge – A form of pitting corrosion found in pharmaceutical water for injection (WFI) systems. It must be removed chemically, either by electropolishing for repassivation.
Sanitary Fitting – used to join two or more pipes or tubes together or to some other component.
Screen Gaskets – stainless steal mesh or filter cloth, which provide elimination of particulates, to protect fill and finish sterile products.
Seal – a device designed to prevent or control the movement of fluid from one chamber to another.
Seal Coat or Base Coat – First layer of coating sprayed on the tablet. This first barrier is then used as a foundation to apply additional coatings.
SIP – Steam-in-place, heating or chemical sterilization of process equipment.
Solid Dosage – Term used in the pharmaceutical industry to refer to drugs that are intended for ingestion (vs.injection). Types of solid dosage drugs include tablets, capsules, granules, and powders.
SOP – Standard Operating Procedure.
Sterilization – A term referring to any process that removes or kills all forms of life present on a surface, contained in a fluid, in medication, or in a compound.
Surface Finish – There are three primary means of classifying surface finish. The first is called the standard mechanical sheet finish and is given with a number and a letter that indicates a process sequence used in the manufacture of stainless steel sheets. The second type of classification is by grit or mesh size. The third is by surface finish measurement using a device such as a profilometer.
Torque – A twisting force that tends to cause rotation
Turnover Package – A package prepared to identify documentation that will readily allow operating companies to demonstrate that the vendor/contractor provided goods and services in compliance with good manufacturing and good laboratory practices for licensed products. The TOP provides the information that will allow the owner to validate, quality, operate and maintain the equipment and facilities.
USP – United States Pharmacopeia, a drug regulating agency.
Validation – As it relates to the spray equipment, the process of validation involves the qualification of the manufacturing process to ensure that it is stable and reliable so that the corresponding manufactured drugs meet specifications. Once an equipment or a process is validated, a new validation is required if any change is made.
Welder Certificate – (also known as welder qualifications) Specially designed tests to determine a welder’s skill and ability to deposit sound weld material. The test consists of many variables, including the specific welding process, type of metal, thickness, joint design, position, and others. Most often, the test is conducted in accordance with a particular code.
WFI – Water for injection (RO-reverse osmosis, DI-deionized water).
31L Stainless Steel – 316SS contains 0.08% carbon. It may develop a heat-affected zone that is sensitized. If this area is exposed to active electrolytes, inter-granular corrosion may occur. 316LSS contains 0.03% carbon, which minimizes this problem.