Industry Terms & Definitions
Abrasion – The process of scarping or wearing away material.
Active Coating – A coating that contains active ingredients. (APIs)
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
CIP – Clean-in-place, equipment and techniques that allow process equipment to be cleaned without dismantling or manual cleaning.
Corrugated – When a object or material is shaped into alternating ridges and grooves usually to make it stronger.
Detectomers – A x-ray and metal detection system that detects contaminants and monitors the consistency and quality of product and package integrity
Excipient – Generally a pharmacologically inactive substance used as a carrier (or enhancer, stabilizer, modifier, etc.) for the active ingredients of a medication. Some of the types of excipients may include antiadherents, binders, coatings (those that do not contain “active drugs”), flavors and lubricants, preservatives, etc.
Extrusion – The process of a material being pushed or drawn through a die of a desired cross-section.
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.
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.
