Medical Pack Solutions 

Glossary

 

Medical Packaging Glossary                                   

Adhesive: a substance capable of the surface bonding together of materials. 

Adhesive lamination: a process in which individual layers of packaging materials are adhesive bonded to each other forming a single sheet.

Adhesive laminate: the sheet formed by adhesive lamination. 

Absorbency: pertains to the amount taken up or the rate of uptake of liquid by an absorbent material such as paper.

AIM: Automatic Identification Manufacturers .AIM International is a global affiliation of trade associations. 

Algorithm: a set of steps taken to make a desired calculation. 

Alphanumeric: character set made up of digits and letters of the alphabet. 

Ambient Temperature: the temperature of the surrounding environment.

Ampoule: single dosage container made from glass sealed after filling by fusing the glass neck. 

ANA (UK): Article Numbering Association. 

Angel Hair: thin strands of film left on the edge of film after imperfect slicing.

Application weight: the amount of adhesive or other coating per unit area. 

Artwork: copy supplied for origination purposes, indicating colour separation and half-tones. 

ASCII: American Standard Code for Information Interchange (a computer code consisting of 128 alphanumeric and control characters used for the exchange of information between computerised systems). 

Aseptic packaging: a system in which the product is sterilised before filling into pre-sterilised packs under aseptic conditions. 

Auger feed: screw feeder used to discharge known volumes of powder or paste products. 

Auto discrimination: the ability of a bar code reader system to distinguish automatically between two or more symbologies. 

Bar code: an array of parallel rectangular bars, arranged according to specific rules, to represent data in machine-readable form. 

Bar code character:  a group of bars and spaces within a bar code that represent a single letter, number or character.  

Bar code density: the number of characters that are represented in a bar code per unit of length (characters per inch, cpi.). 

Bar code reader: a device used to capture the data encoded within a bar code and convert it into computer compatible data or a human readable characters display. 

Bar code symbol: the combination of characters required by a particular symbology that makes up a scan able entity. 

Barrier film: specially formulated film designed to minimise the transmission of gases and liquids.

Batch code: combination of characters that facilitates tracing of the product to the batch in which it was processed (see LOT). 

Bi-Axial Orientation: terminology applies to film, which has been pre-stretched in both the X and Y-axis to increase tear strength and give balanced properties.

Bill of Materials (BOM): a listing of components and quantities, including descriptions and /or item numbers.

Bioburden: population of viable microorganisms on an item (ref. ISO 11607:2003(E)). 

Biodegradable: degradable under natural conditions, e.g. in landfill. 

Blister pack: a piece of thermoformed material bonded to flat material to form a closure (lid).  

Blister packer: a system to fill, lid and seal blister packs.

Blown Film: produced by using air pressure to expand plastic film as it is extruded from a circular die. 

Board: papers equal to or greater than 220gsm.

BOM: see Bill of Materials. 

Bond: the union of two substrates. 

Bowl feeder: vibratory bowl used to feed components up a spiral ramp. 

Bursting Strength: the resistance of paperboard to rupture under pressure. Usually measured on a Mullen tester.

Calliper: the thickness of a sheet of board. 

Carton: a container made from folding boxboard and supplied flat for erection when filling. 

Carton blank: an unglued carton, which is glued during the filling process. 

Cartonboard: material of defined substance and thickness made from one or more layers of paper to form a rigid or semi-rigid sheet.

Cartoner: a machine that erects and closes carton blanks or folded side seam sealed cartons.

Cast Film: film that is formed by extrusion from a flat die onto a chilled roller.

Cat’s whisker: the sharp pointed protrusion from a blister that can arise when using a cross cutting blade and slitter to cut out individual packs on a form fill seal machine. 

Cavity wall: a carton or fitment where the sidewalls are constructed so as to form a hollow frame effect.    

Chase: a frame used for locking cutting forms in place. 

CFR: Code of Federal Regulations (USA).

Check character (check digit): a character calculated from the numerical value of the other characters in the code that is used to ensure that the code is correctly processed. 

Chevron pouch: a pouch where one end seal is in the shape of a chevron (like sergeants stripe). 

Closure: means used to close a package where no seal is formed. EXAMPLE: Repeated folding to construct a tortuous path (ref. ISO 11607-1:2006). 

Closure integrity: characteristics of the closure, which that ensures that it prevents the ingress of microorganisms under specified conditions (ref. ISO 11607-1: 2006). 

Compliance qualification: Documented evidence that packaging meets the requirements for packaging for terminally sterilized medical devices based on testing for conformity to an agreed material specification (ref. ISO 11607: 2003(E)). 

Code 39 (3 of 9): a bar code symbology that encodes 43 data elements (0-9, A-Z and 7 special characters). Each character has 9 elements, bars have two widths. 

Code 128:  a bar code symbology that encodes the complete 128 ASCII characters set. Characters are made up of bars and spaces in three widths. 

Co- extrusion: a multi-layer structure prepared by extruding a number of polymers through a single die (with tie layers as necessary). 

Cohesive failure: failure of a bond within the adhesive itself.

Cold Flex: the ability of a film to perform at low temperatures without failure.

Container Board: solid fibre or corrugated board used in the manufacture or shipping containers (cases). 

Contaminants: any unacceptable or unintended trace materials. 

Corona Treatment: a technique whereby the surface of plastic film is exposed to a high voltage electrical discharge to increase its receptivity to inks, coatings or adhesives. Treatment level is expressed in dynes.

Corrugated board: board consisting of one or more fluted sheets between flat facing plies. 

Crash-bottom carton: a carton where the base panel locks in place when the body is squared up. 

Crashlock base: a carton where the base locks in place automatically when pressed from opposite corners. 

Delamination: the separation of the components of a layered material.

Development: process of refining a prototype design or process to meet established product criteria (ref. ISO 11607: 2003(E)). 

Die: (i) solid sheet or cylinder into which knives and rules are fixed to create carton shapes.

Die: (ii) solid sheet or cylinder into which knives are fixed to create label shapes.   

Die-cut labels: labels that are cut to shape by a cutting die. 

Double tuck carton: carton in the form of a sleeve, with extended side flaps that tuck in to form the end closures. 

Drop Test: method of comparing performance by dropping from predetermined heights and positions then observing and recording the resulting damage.

DSD: Duales System Deutschland. 

Dunnage: padding used to fill an empty space in a shipping container.

Duplex board: a multi-ply board mainly made from mechanical pulp with a bleached chemical pulp-facing layer. 

Dwell time: the time that is required for the application of heat to bond two surfaces.

EAN: Originally European Article Number and now used to denote International Article Number and the International Article Numbering Association. 

EAN-8: Short form, 8-digit version of the International Article Number. 

EAN-13: Full 13-digit version of the International Article Number. 

Edge Crush Test (ECT): a test for measuring the structural strength of corrugated board, an indicator of column stacking strength of containers.

Elmendorf Tear Test: a standard test for measuring tearing resistance of sheet materials.

Expiry date (1): Expiry (Exp) Date Nov 2001 means do not use this product after November 2001.   

Expiry date (2): Indication of the date, by which the product should be used, expressed at least as the year and month (ref. ISO 11607-2: 2006). 

Extrusion: the process of pushing a material through a die.

Extrusion lamination: a process in which individual layers are laminated by extruding a thin layer of molten resin (such as polyethylene) between the layers. 

Failure: event in which a component of the package does not perform one or more of its required functions within the specified limits under specified conditions (ref. ISO 11607: 2003(E)). 

Failure analysis: logical, systematic examination of an item to identify and analyze the probability, causes and consequences of potential and real failures (ref. ISO 11607: 2003(E)).  

Field: an area in a computer file designated for one item of data. 

Film: a non-fibrous, non-metallic flexible material available in a range of thickness. 

Final package: primary containment system in which the product is sterilized (excluding shelf cartons and shipping containers) that protects the contents to the intended level over a specific period of time. Note: The intended level may be e.g. a barrier to physical, microbial or chemical challenges (ref. ISO 11607: 2003(E)). 

Flexography: a rotary printing process that prints by the use of flexible relief plates that directly apply the image to the substrate. 

Flute: a wave shape in the inner portion of corrugated board.

Foil: rolled metal in flexible sheet form. Typically this is aluminium sheet, available in a range of thickness. 

Form/fill/seal: a system where packs are formed (typically from film or foil), filled and closed in one continuous operation. 

Gang: the term used to describe a grouping of labels supplied in sheet form 

Gravure: a printing process where the image is engraved (electronically or chemically) in the form of cells in the surface of a metal cylinder. Ink is transferred to the substrate by passage between the inked cylinder and an impression cylinder under pressure. 

GS1: Formerly EAN International.  

Guard bars: auxiliary characters at both ends and centre of EAN/UPC bar codes which provide reference points for scanning and act as start/stop characters. 

Gusset: the folded inward portion of a flexible bag. 

Heat-seal able film: film that may be joined to itself or another substrate through the use of heat and pressure (without the use of adhesives).

Heat Seal Coating: a surface coating that allows a material to be bonded to another by the application of heat and pressure.

Heat-sealing: joining together by using heat and pressure. 

Heat-sealing adhesive: an adhesive coating previously applied that forms a bond between two surfaces when heat and pressure is applied.

Heat shrinking: application of heat to shrink a band of plastics material around product.  

IATA: International Air Transport Association – publishes packaging instructions for the air transport of hazardous goods.

Impulse sealing: short rapid electrical resistance heating of metal strip or wire to seal plastics film. 

Impact strength: resistance of a plastic film to shock impact. Measured by dropping weighted round ‘dart’ onto the film from a given height. Also known as ‘Dart Impact’ strength.

Installation Qualification (IQ): process of obtaining and documentating evidence that equipment has been provided and installed in accordance with its specification (ref. ISO 11607-2: 2006).

Ink Jet Printing: non-contact printing process that uses a modulated jet of ink to spray the image onto the substrate. 

Kraft Paper: paper made entirely from wood pulp by a modified sulphate pumping process.

ISTA: International Safe Transit Association – publishes test methods for vibration and shock testing of filled packages.

Label [1]: the USA Federal Food, Drug and Cosmetic Act in Section 201(k) defines "label" as a "display of written, printed, or graphic matter upon the immediate container of any article..."  

Label [2]: ASTM, D 996 defines label as a piece of paper or other material to be affixed to a container or article, on which is printed a legend, information concerning the product, or addresses. It may also be printed directly on the container. 

Labeling (1): the USA Federal Food, Drug and Cosmetic Act in Section 201(m) defines "labeling" as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article" at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.   

Labeling (2): written, printed, electronic or graphic matter affixed to a medical device or its packaging; or accompanying a medical device (ref: ISO 11607-1:2006 and ISO 11607-2: 2006).  .

Labelling: information on the immediate or outer packaging (Ref: EU Council Directive 92/27/EEC of March 1992). 

Labelling System [1]: assembly of the package and label and any supplied information on usage that is included within or in contact with the final package (ref. ISO 11607: 2003(E)). 

Labelling System [2]: the means by which information is controlled and applied to a packaging component.  

Laminate: a material made by joining together complete surfaces of any combination of films, foils and papers. 

Letterpress: a printing process where ink is transferred from raised areas to the substrate under pressure. 

Lidding Stock: material used to seal a blister pack.  

Lithography: a printing process in which oil based ink is transferred from ink retaining areas on a treated plate to a substrate. Water is used to contain the ink in the required areas. In offset lithography the image is transferred first to a rubber blanket and then the substrate. 

Life Cycle Analysis: the measurement and aggregation of all factors relating to the production, use and disposal of materials. 

L-Sealer: term describes equipment where the resulting seal is in the shape of an "L". 

Manufacturer: natural or legal person, individual or organization with the responsibility for packaging and/or sterilizing the medical device (ref. ISO 11607: 2003(E)).  

Manufacturer Number: the digits allocated by an EAN numbering authority to a labeller which, together with the prefix, item reference and check digits, make up the standard article number. 

Manufacturers joint: the part of a case that is joined together by the manufacturer.  

Metallised films: flexible films coated with an ultra-thin layer of metal, usually aluminium. 

Microbial barrier: property of the sterile barrier system that prevents the ingress of microorganisms under specified conditions (ref. ISO 11607-1: 2006). 

Modified Atmosphere Packaging: a process by which air in a pack is replaced with another gas.

Mullen Tester: used to measure the bursting strength of paper (mechanical replacement for the papermakers thumb).    

MVTR: Moisture Vapour Transmission Rate is the quantity of moisture transmitted (through a barrier) during a specified period of time. 

Offset Printing: process of printing by indirect image transfer (ink transfers to a rubber coated cylinder and then to the final printed surface).   

One-trip: pack or container designed for single use only.   

Operational Qualification (OQ): process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures (ref. ISO 11607-1: 2006). 

Over wrap: a wrapping enclosing one or more packs. 

Package integrity: unimpaired physical condition of a final package. 

Packaging compatibility: attribute of the packaging material and/or system to allow it to achieve the required performance without detrimental effect on the medical device (ref. ISO 11607: 2003(E)). 

Packaging material: any material used in the fabrication or sealing of a packaging system (ref. ISO 11607-1: 2006). 

Packaging system (1): combination of the sterile barrier system and protective packaging (ref. ISO 11607-1: 2006 and ISO 11607-2: 2006). 

Packaging system (2): process by which one or more packaging materials are formed into a product container.  

Parallel tuck carton: a carton with both tuck ends attached to the same panel. 

Partial over wrap: a wrapping partially enclosing one or more packs. 

Peel seal coating: this is a Heat Seal Coating with the characteristic that the bond will allow the two materials to be manually pulled apart.  

Peel strength: the measured stress through peeling of a bonded surface resulting in an adhesive failure. 

Performance qualification (PQ): process of obtaining and documentating evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification (ref. ISO 11607-2: 2006).  

Eastar PETG copolyester 6763, a glycol-modified polyethylene terephthalate, is a clear amorphous polymer. The modification is made by adding a second glycol, cyclohexanedimethanol, during the polymerisation stages. 

PET: polyethylene terephthalate. 

Plug: a push fitting closure.

Plug lid: a removable lid that is a push fit into the opening of a container. 

Pouch: a rectangular bag with three sides sealed prior to filling and closing.   

Preformed sterile barrier system: sterile barrier system that is supplied partly assembled for filling and final closure or sealing (ref. ISO 11607-1: 2006 and ISO 11607-2: 2006).

Primary Pack: the definition of this term in EN 868-1 is synonymous with the above definition of Final Package (ref. ISO 11607: 2003(E)). 

Primary package: sealed or closed packaging system that forms a microbial barrier, enclosing a medical device (ref. ISO 11607: 2003(E)). 

Printer-slotter: a printing machine which also converts corrugated board into cases using simple wheel or cross creasing and punch-slotting devices.  

Producer:  natural or legal person, individual or organisation with the responsibility for manufacturing the packaging material and/or system (ref. ISO 11607: 2003(E)). 

Product: result of a process (ref. ISO 11607-1: 2006).   

Protective Packaging: configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of assembly until the point of use (ref. ISO 11607-1: 2006 and ISO 11607-2: 2006). 

Push fit closure: a closure, usually plastic, that is pushed into the neck or opening of a container to form a seal and is held in place by friction. 

Qualification: documented evidence that all specified design and performance requirements are met (ref. ISO 11607: 2003(E)). 

Release coating: coating applied to label backing paper to aid removal of self-adhesive labels. 

Release paper: easily removed backing paper for self-adhesive labels. 

Relieved area: an area, outside the product containment zone, that is designated to remain not sealed; this is to facilitate ease of opening.   

Reusable container: rigid sterile barrier system designed to be repeatedly used (ref. ISO 11607-1: 2006). 

Revalidation: documented procedure to reconfirm an established validation (ref. ISO 11607: 2003(E)). 

Reverse tuck in end carton: carton where the end tuck flaps are extensions of opposite carton faces. 

Sachet: a small flexible package made by bonding two layers together on all four sides. 

Seal: result of joining surfaces together. NOTE: For example, surfaces can be jointed together by use of adhesives or thermal fusion (ref. ISO 11607-1: 2006).

Seal integrity: characteristics of the seal, which ensures that it prevents the ingress of microorganisms under specified conditions (ref. ISO 11607-1: 2006).

Seal strength: mechanical strength of the seal (ref. ISO 11607-1: 2006).

Secondary Container: container that holds one or more primary containers.   

Self-adhesive: an adhesive that bonds by pressure only. Used for pressure-sensitive labels. 

Self-checking: denoting a bar code system using a checking algorithm. 

Shaft encoder: a device, for measuring the speed of an object that converts this information into a series of signals, which may be interpreted by an ink jet printer. 

Shelf life: the period of time during which a packaged product retains its minimum acceptable quality or safety. 

Shrink-banding: heat tightening of a band of plastic material, to collate goods or seal a closure (may alternatively be achieved by moisture loss from a cellulose band). 

Shrink wrapping: over-wrapping in plastic film, which retracts when heated to produce a tight wrap.  

Skin packaging: using vacuum to pull heat-softened plastic film tightly over a product whilst sealing the film to an underlying porous surface. 

Start/stop character: a bar code character included in a symbol to indicate to the scanner the beginning and end of the code. 

Sterile: free from viable microorganisms (ref. ISO 11607-1: 2006). NOTE: For the purposes of EN 868-1, the term sterile is defined in EN 556.  

Sterile barrier system (1): the means by which a manufacturer ensures that a sterilized device remains in a sterile state until used in the manner intended. Typically such a system comprises a sealed unit surrounding the device that is an integral part of the product. When a healthcare professional purchases a sterile medical device, sterility is part of the product (ref. EUCOMED-ESPA Position Paper: Sterile barrier systems and Directive 94/62/EC).   

Sterile barrier system (2): minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use (ref. ISO 11607-1: 2006).   

Sterile fluid-path packaging: system of protective port covers and/or packaging designed to ensure sterility of the portion of the medical device intended for contact with fluids (ref. ISO 11607-1: 2006). 

Sterilization compatibility: attributes of the packaging material and/or system that allow it to both withstand the sterilization process and attain the required conditions for sterilization within the packaging system (ref. ISO 11607-1: 2006)  

Sterilizing agent: physical or chemical entity, or combination of entities having sufficient microbicidal activity to achieve sterility under defined conditions (ref. ISO 11607-1: 2006). 

Stretch wrapping; a method of wrapping/collating product with an elastic film under tension.  

Symbol length: total length of a bar code including the quiet zones preceding the start code and following the stop code. 

Symbology: the system of representing data in a bar code. 

Tamper-evident closure: a closure that incorporates a feature that indicates any unauthorised tampering or interference. 

Terminal sterilization: process by which a product is sterilised within its sterile barrier system (ref. ISO 11607-1: 2006). 

Terminally sterilized: term for medical devices that are sterilized after being completely sealed or enclosed in at least the primary package (its sterile barrier system). 

Thermal printing: the system whereby direct heating of the paper by the print head produces an image. 

Thermal transfer printing: the system where the heating, by a print head, of an ink layer on a thin film, causes ink to be released and transferred to a substrate. 

Thermoforming: a process where film softened by heat is forced into or over a mould. 

Thermoform/fill/seal: a system where packs are thermoformed from a plastic sheet; then filled and lidded in one continuous operation. 

Thermoplastic: a plastic that softens when heated and re-hardens when cooled. 

Tyvek®: a Dupont product. Non-woven spun bonded, polyethylene sheeting with good bacteria penetration resistance; made from very fine, high-density polyethylene fibres. 

UCC: Uniform Code Council, the American organisation that administers the UPC system in North America. 

UPC: Uniform Product Code, the American standard article number. 

Use by date: Use by Nov. 2009, means do not use this product after 31st October 2009. 

User: natural or legal person, individual or organisation with the responsibility for making use of the product (ref. ISO 11607: 2003(E)). 

Vacuum pack: a package from which the air has been withdrawn before sealing. 

Vacuum packaging: the withdrawal of air from a pack immediately prior to sealing its closure.   

Validation: (general) confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled (ref. ISO 11607-1: 2006).  

Validation Master Plan (VMP): document that outlines the scope of the work to be done, the responsibilities and the general approach. The plan may relate to a new plant, product or a new system. 

Validation: (process) documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications (ref. ISO 11607-1: 2006).  

Validation Protocol: the documentation describing the tests and instructions that are executed for equipment, process, packaging or analytical method validation etc.

VCI paper (Vapour Corrosion Inhibitor): paper impregnated with an inhibitor that creates, when placed within a sealed package, a corrosion-resisting environment for specified metals.

 


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