Adhesive: a substance capable of the surface
bonding together of materials.
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.
Ampoule: single dosage container made from
glass sealed after filling by fusing the glass neck.
ANA
(UK): Article
Numbering Association.
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.
Batch
code: combination
of characters that facilitates tracing of the product to the batch in which it
was processed (see LOT).
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.
Board: papers equal to or greater than
220gsm.
Bond: the union of two substrates.
Bowl
feeder: vibratory
bowl used to feed components up a spiral ramp.
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.
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.
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 11607:2003(E)).
Closure
integrity:
Condition of the closure that ensures that the closure presents a microbial barrier
to at least the same extent as the rest of the packaging (ref. ISO 11607: 2003(E)).
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.
Contaminants: any unacceptable or unintended
trace materials.
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.
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.
DSD: Duales System Deutschland.
Duplex
board: a multi-ply
board mainly made from mechanical pulp with a bleached chemical pulp facing
layer.
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.
Expiry date. Expiry (Exp)
Date Nov 2001 means do not use this product after November 2001.
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.
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.
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-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.
Impulse
sealing: short
rapid electrical resistance heating of metal strip or wire to seal plastics
film.
Ink Jet
Printing:
non-contact printing process that uses a modulated jet of ink to spray the
image onto the substrate.
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: 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.
Labelling: Council Directive 92/27/EEC of March 1992 on the labeling of medicinal products for human use and on package leaflets defines “Labelling” as “information on the immediate or outer packaging”.
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.
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.
Manufacturer’s
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: attribute
of the packaging system that prevents the ingress of microorganisms under
specified conditions
(ref. ISO
11607: 2003(E)).
Modified
Atmosphere Packaging:
a process by which air in a pack is replaced with another gas.
MVTR: Moisture Vapour Transmission Rate
is the quantity of moisture transmitted (through a barrier) during a specified
period of time.
One-trip: pack or container designed for
single use only.
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 or primary
package (ref. ISO 11607: 2003(E)).
Packaging
system (1): one or
more packaging materials assembled into a single unit intended as part or all
of a
primary
package (ref. ISO 11607: 2003(E)).
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
strength: the
measured stress through peeling of a bonded surface resulting in an adhesive
failure.
Performance
qualification:
documented evidence that packaging meets the appropriate requirements for sterile
packaging based on testing of the particular packaging material for compliance
with the applicable requirements of this international standard (ref.
ISO 11607: 2003(E)).
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 polymerization 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.
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: combination of both the medical
device and/or additional components with the final package (ref. ISO 11607: 2003(E)).
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.
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 of packaging
layers.
NOTE: A seal may be created, e.g., by use of
adhesives or thermal fusion (ref. ISO 11607: 2003(E)).
Seal
integrity:
condition of the seal that ensures that it presents a microbial barrier to at
least the same extent as the rest of the packaging
Note: In EN
868-1 the definition of this term differs slightly (ref. ISO 11607: 2003(E)).
Seal
strength:
mechanical strength of the seal (ref. ISO 11607: 2003(E)).
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.
NOTE: For
the purposes of EN 868-1, the term “sterile” is defined in EN 556 (ref. ISO 11607: 2003(E)).
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: 2003(E)).
Sterile barrier
system: 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).
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 final package
(ref. ISO
11607: 2003(E)).
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.
Terminally sterilized: term for medical devices that are sterilized after
being completely sealed or enclosed in at least the primary package.
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: 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: 2003(E)).
The Webmaster welcomes suggestions for additional terminology
Email to: - Rolande@MedicalPackConsultant.com