Industry Terms

Abrasion - The process of wearing, grinding or rubbing away of material.   

Active Coating - A coating that contains active ingredied

API - Active Pharmaceutical Ingredients - any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product.

ASME BPE - American Society of Mechanical Engineers: Bioprocessing Equipment) is an international standard developed as an aid for the design and construction of equipment intended for use in the manufacturing of biopharmaceuticals. The standard is approved as an American National Standard by the American National Standards Institute (ANSI).

Autogeneous Welding - A weld joint developed by melting the fating surfaces and subsequently solidification only (without using any filler metal).

Biopharmaceutical - A pharmaceutical derived from biological sources and especially one produced by biotechnology.

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.  

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 Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

Change Control Record - A formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change.

CIP - Clean-in-place is a method of cleaning the interior surfaces of pipes, vessels, process equipment, filters and associated fittings, without disassembly.

Corrugated - (Of a material or surface) shaped into a series of parallel ridges and grooves so as to give added rigidity and strength.

Detectomers - A x-ray and metal detection system that detects contaminants and monitors the consistency and quality of product and package integrity

Drug - A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

Elastomer - A natural or synthetic polymer having elastic properties. 

Electropolishing - Also known as electrochemical polishing, anodic polishing or electrolytic polishing (especially in the metallography field), is an electrochemical process that removes material from a metallic workpiece. It is used to polish, passivate, and deburr metal parts. It is often described as the reverse of electroplating. 

Enteric Coating - An enteric coating is a polymer barrier applied on oral medication that prevents its dissolution or disintegration in the gastric environment. This helps by either protecting drugs from the acidity of the stomach, the stomach from the detrimental effects of the drug, or to release the drug after the stomach (usually in the upper tract of the intestine).

Excipient - A usually inert substance (such as gum arabic or starch) that forms a vehicle (as for a drug). 

Extrusion - The process of a material being pushed, drawn or forced through a hole. 

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 – The action of creating or preparing a mixture of structures prepared to a specific procedure.  

Full Penetration - Describes the type of weld where the fused joint is completely solid with no gaps after welding. 

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 - Hydroxypropyl cellulose is a derivative of cellulose with both water solubility and organic solubility. It is used as an excipient, and topical ophthalmic protectant and lubricant.

HPMC - Hydroxypropyl methylcellulose, is a semisynthetic, inert, viscoelastic polymer as an excipient and controlled-delivery component in oral medicaments, found in a variety of commercial products.

Installation Qualification (IQ) - Documents which establish that the critical components of a system are installed correctly and in accordance with the design documentation requirements. 

Modified Release Coating - Film coatings applied to the solid dose form to alter the release of API in a dosage form after it is ingested. 

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 - Film coatings applied to tablets for improved product appearance and improved handling. 

O-Ring - A gasket in the form of a ring with a circular cross section, used to seal connections in pipes and tubes. 

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 - Is a specialized area of welding whereby the arc is rotated mechanically through 360° (180 degrees in double up welding) around a static workpiece, an object such as a pipe, in a continuous process.

Orifice Plate - A thin plate with or without a bore, usually placed in a fluid pipe, to commonly measure or stop flow rates. 

Passivation - Refers to a material becoming "passive," that is, less affected or corroded by the environment of future use. Passivation involves creation of an outer layer of shield material that is applied as a micro-coating, created by chemical reaction with the base material, or allowed to build from spontaneous oxidation in the air. As a technique, passivation is the use of a light coat of a protective material, such as metal oxide, to create a shell against corrosion

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. 

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 - Polytetrafluoroethylene; a polymer with excellent chemical resistance noted for its slippery, non-sticking properties. 

PVA - Polyvinyl alcohol. Used in certain coating systems. 

Quality Control -  A process by which a given entity reviews the quality of all factors involved in production of a given drug, product or compound.

Quarantine - The compulsory isolation of a substance typically to contain the spread of something considered dangerous. 

Riboflavin Test - In cases of organic residues in vessels, a common practice is to spray the inner surfaces with a solution of riboflavin 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 re-passivation.

Sanitary Fitting - Used to join two or more pipes or tubes together or to some other component.

Screen Gaskets - Stainless steel 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 - Refers to drugs that are intended for ingestion. Types of solid dosage drugs include tablets, capsules, granules, and powders. 

SOP - Standard Operating Procedure.

Sterilization - The process of making something free from bacteria or other living microorganisms. 

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.

WFI - Water For Injection is water that is intended for use in the manufacture of medicines for parenteral administration whose solvent is water (WFI in bulk), or water that is used to dissolve or dilute substances or preparations for parenteral administration (heat- sterilized WFI).

316L 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.