|
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.
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: 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.
|
|