This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles

for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Designation: F17 − 20

Standard Terminology Relating to

Primary Barrier Packaging1
This standard is issued under the fixed designation F17; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.

1. Scope accumulative pump, n—a mechanical pump dispenser that

1.1 This terminology covers the principal terms relating to accumulates internal pressure by means of a valving-system
primary barrier packaging and its materials. This terminology that maintains a high velocity flow of the product no matter
contains related definitions and descriptions of terms used or what the actuation velocity that results in a consistent fine
likely to be used in primary barrier packaging standards. The mist spray.
purpose of terminology is to promote clear understanding and acid foods—foods that have a natural pH of 4.6 or below.
interpretation of the standards in which they are used.
adhesive transfer—a condition occurring when an adhesive-
1.2 This international standard was developed in accor- coated material is peeled away from an opposing material to
dance with internationally recognized principles on standard- which it has been sealed and shows visible evidence of the
ization established in the Decision on Principles for the adhesive being left on the opposing material. This evidence
Development of International Standards, Guides and Recom- is in the form of an adhesive layer that remains with the
mendations issued by the World Trade Organization Technical opposing material, the adhesive having separated either
Barriers to Trade (TBT) Committee. adhesively from the coated web or cohesively within the
adhesive itself.
2. Referenced Documents
aseptic—as applied to aseptic packaging, synonymous with
2.1 ASTM Standards:2 commercially sterile.
D883 Terminology Relating to Plastics
D1129 Terminology Relating to Water aseptic packaging—filling of a commercially sterilized prod-
F1349 Test Method for Nonvolatile Ultraviolet (UV) Ab- uct into presterilized containers, followed by hermetic seal-
sorbing Extractables from Microwave Susceptors ing in a commercially sterile atmosphere.
F1980 Guide for Accelerated Aging of Sterile Barrier Sys- aseptic presentation—introduction and transfer of a sterile
tems for Medical Devices product using conditions and procedures that exclude micro-
bial contamination.
3. Terminology
atomization, n—the separation process of liquid into small
accelerated aging—a technique to simulate the effects of time particles.
on a package by subjecting the product/package system to
barrier—any material limiting passage through itself of solids,
elevated temperatures in a controlled environment represen-
liquids, semisolids, gases, vapors, or forms of energy such as
tative of controlled environment storage conditions. The
ultraviolet light.
equivalent time is generally estimated by assuming the
degradation of packaging materials follows the kinetics barrier materials—specialized porous or nonporous packag-
described by the Arrhenius reaction rate function, more ing materials that provide environmental protection to the
discussion of which is available in Guide F1980. package contents as well as protection to the environment
from the package contents: (1) gas, vapor, humidity, liquid,
microbial, or light resistant materials that control or elimi-
1
This terminology is under the jurisdiction of ASTM Committee F02 on Primary
nate the amount of those environmental constituents that
Barrier Packaging and is the direct responsibility of F02.50 on Package Design and pass into or out of a package; (2) a porous material
Development. preventing the passage of microorganisms that might con-
Current edition approved May 1, 2020. Published August 2020. Originally taminate the contents of the package.
approved in 1961. Last previous edition approved in 2018 as F17 – 18a. DOI:
10.1520/F0017-20.
2
biological evaluation test (biotest)—a test which involves
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [email protected]. For Annual Book of ASTM
exposure of sealed packages to biological indicators and is
Standards volume information, refer to the standard’s Document Summary page on designed to determine the microbiological integrity of a
the ASTM website. package under the specific conditions of the test.

Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
 F17 − 20
burst strength—a measure of the internal pressure necessary surface of another (solid) material, forming a continuous
to rupture a package or seal. layer upon cooling. (2) Also, the product resulting from such
a process.
channel—any unimpaired pathway across the entire width of
the intended seal. fine mist pump, n—a mechanical pump dispenser that atom-
izes liquid into a fine mist. An accumulative pump is the
clogging, v—the restriction of normal product flow. Most
most common type of fine mist pump.
commonly due to product drying in a product flow passage
area of the mechanical break-up system. flexible—easily hand-folded, flexed, twisted, and bent.
DISCUSSION—“Flexible” may be a characteristic of thin barrier
coextrusion—in flexible barrier materials, (1) a process materials, especially when thinner than 125 to 255 µm (5 to 10 mils),
whereby two or more plastic streams are forced simultane- that are composed of materials that are otherwise classified as “rigid”
ously through one or more shaping orifices to become one or “semi-rigid” under the definitions concerning rigidity based on
continuously-formed multilayered structure. (2) Also, the modulus of elasticity (see Terminology D883). Modulus of elasticity is
product resulting from such a process. an inherent property of a material which in conjunction with thickness
determines flexibility.
commercial sterility— of thermally processed food, the con-
dition achieved by application of heat, alone or in combina- flexible package—any package with at least one flexible
tion with other appropriate treatments, to render the food component that can be bent back or folded back upon itself.
free of microorganisms capable of growing in the food at fluoroptic temperature measurement—temperature mea-
normal nonrefrigerated conditions at which the food is likely surement based on the variation in total luminescence of a
to be held during distribution and storage. fluoroptic phosphor which has been previously calibrated
conditioning—the exposure of a material to the influence of a versus a known temperature standard.
prescribed atmosphere for a stipulated period of time or until food simulant—a well-characterized substance used in place
a stipulated relation is reached between material and atmo- of food for investigative studies.
sphere.
force to actuate (FTA), n—the peak force that corresponds to
cross direction (CD)—the direction perpendicular to a mate-
the pressure on the finger that a consumer feels upon fully
rial’s flow through the machine on which the material is
actuating the mechanical pump dispenser.
being produced or processed. Material orientation perpen-
dicular to the flow direction through a machine may have functional barrier—in food packaging, a material that effec-
different properties than machine direction. Also known as tively restricts passage of solids, liquids, semi-solids, vapors,
transverse direction (TD). or forms of energy such as ultraviolet light through itself,
across its borders, or interface with another material or
delamination—the separation of layers in a multilayered
substance.
structure.
dispersion coating—in flexible barrier materials, (1) a pro- functional compatibility, n—effect of physical or chemical
cess of applying a material, suspended or dispersed in a interaction between a consumer product and a specific pump
vehicle, to a surface in such a way that a continuous, mechanism where problems typically include deformation
coalesced, adherent layer results when the vehicle liquid and degradation of components that result in a lower
(usually water) is evaporated. (2) Also, the product resulting performance of the mechanical pump dispenser.
from such a process. fusion seal—a bond formed by combining two or more
dual ovenable—terms describing a food packaging container materials through melting or other means so that the joining
used to prepare food in either a conventional oven or a layers become indistinguishable at the interface.
microwave oven. heat seal—the result of bonding surfaces by controlled appli-
environmentally challenging—the process of subjecting a cation of heat, pressure, and dwell time.
package to extremes of temperature and/or humidity and/or hermetically sealed aseptic container—a container that is
other environmental conditions, with the goal of determining designed and intended to be secure against the entry of
sensitivities of the package to environmental stresses. In microorganisms and thereby to maintain the commercial
contrast to accelerated aging, environmental challenging sterility of its contents.
often includes conditions, or transitions, or both, of tempera-
ture and humidity that equal or exceed those that can be hot spot, n—the area of a spray where the product concentra-
encountered in a package life cycle. tion is high which can be visibly seen on a spray pattern as
a concentrated stain on the alcohol-sensitive paper.
exit orifice, n—the final passage found in the insert that the
liquid flows through before exiting the dispensing system hot tack—the property of a heat seal to hold together when
where the size of the orifice diameter can determine the size stressed while it is still hot from the sealing operation.
of the spray particles and spray pattern.
laminate—a product made by bonding together two or more
extrusion coating—in flexible barrier materials, (1) a process layers of material or materials. (See also multilayered
of extrusion whereby a molten extrudate adheres to the structure)

2
 F17 − 20
lamination—in flexible barrier materials, the process of microbiological package integrity—the physical condition of
preparing a laminate which consists of two or more flexible a finished package, including, but not limited to, the security
barriers bonded together (see also laminate). of package seals, which ensures the maintenance of the
package contents in a commercially sterile condition.
leak—a hole, void, or defect in the package material or mated
components of a package capable of passing particulate, microwave extraction cell—a polytetrafluoroethylene cell
aerosols, liquid, or gas from one side (inside or outside) of used for evaluating microwave active materials. Refer to
the package to the other side contrary to intention. Test Method F1349 for schematics of cell construction.
load (water load)—an amount of water used to moderate the microwave only food package—a container used to heat
microwave radiation absorbed by a susceptor during simu- foods only in a microwave oven.
lated microwave heating tests.
microwave susceptor—packaging material that, when placed
low-acid food—any food, other than alcoholic beverages, with in a microwave field, is designed to interact with the field
a finished equilibrium pH greater than 4.6 and a water and provide substantial heat to the package contents.
activity (aw) greater than 0.85. Tomatoes and tomato prod-
ucts having a finished equilibrium pH less than 4.7 are not minor package defect—a defect that does not significantly
classed as low-acid foods. reduce the usability of the package for its intended purpose,
or that is a departure from established standards having little
machine direction (MD)—the direction parallel to a materi- or no bearing on the effective use of the package.
al’s flow through the machine on which the material is being
produced or processed. Flow direction through a machine multilayered structure—in flexible barrier materials, a struc-
may impart directional properties to a material. Also called ture that consists of two or more continuous layers or plies
longitudinal direction (LD). of material.
DISCUSSION—Processes such as lamination, coextrusion, extrusion
major package defect—a defect that is likely to result in coating, and solution or dispersion coating can be used to make
failure or reduce significantly the usability of the package for multilayered structures. (See also laminate).
its intended use.
nonporous packaging material—material which does not
mechanical break-up unit (MBU), n— a design structure have pores or minute openings to allow volumetric air flow.
found in the insert that forces product to flow in a swirling
method for producing specific spray characteristics. nonvolatile extractables— (1) for purposes of the ASTM tests
for volatile extractables and nonvolatile extractables, non-
mechanical pump dispenser, n—a small, finger- or hand- volatiles shall be defined as those compounds that give more
actuated, mechanical device used to dispense (spray, stream, than 50 % recovery in studies using the applicable nonvola-
or flow) product from a container that may be, generally, tile extractables method; (2) in microwave packaging, those
held in one’s hand. chemical species that are released from microwave food
packaging under simulated use conditions and are detected
medical device—any instrument, apparatus, implement, using an applicable nonvolatile extracables method.
machine, appliance, implant, in vitro reagent or calibrator,
software, material, or other related article, intended by the output per stroke (OPS), n—the amount of product dispensed
manufacturer to be used, alone or in combination, for one of with one complete actuation when measured in terms of
more of the specific purpose(s) of (1) diagnosis, prevention, weight (grams) or volume (microliter, milliliters, or cc’s).
monitoring, treatment, or alleviation of a disease; (2)
diagnosis, monitoring, treatment, alleviation of or compen- package—a container providing protection to a product during
sation for an injury; (3) investigation, replacement, modifi- distribution, storage, retailing, and use.
cation or support of the anatomy or of a physiological package integrity—the physical capability of a given package
process—supporting or sustaining life; (4) control of con- to protect its contents with the desired level of protection
ception; (5) disinfection of medical devices; and (6) provid- over a defined period of service; for example, as a barrier to
ing information for medical purposes by means of in vitro physical, microbiological, or chemical challenges.
examination of specimens derived from the human body, and
which does not achieve its primary intended action in or on package performance—the ability of the packaging system,
the human body by pharmacological, immunological, or including the primary package or sterile barrier system and
metabolic means, but which may be assisted in its function protective packaging, to withstand the hazards of handling,
by such means. distribution, and storage.
microbial barrier—property of the sterile barrier system that packaging system—combination of the sterile barrier system
prevents the ingress and/or egress of microorganisms under and protective packaging.
specified conditions.
peelable seal—the opening characteristic of forcibly separat-
microbiological contamination (of packaged products)—the ing two package substrates, which have been joined together
entry of viable microorganisms into a finished package due by a sealing process, without tearing, film fracturing,
to lack of or loss of package integrity. delamination, or fiber tear of the substrates.

3
 F17 − 20
permeation—the transfer of a gas or vapor through a nonpo- seal creep resistance—a measure of the ability of a sealed
rous material. package or seal to remain intact when subjected to a constant
force.
pinhole—a small opening of non-specific shape or dimension
that passes linearly and completely through all layers of a seal integrity—(1) characteristics of the seal that ensures that
packaging material. it maintains label claim(s), acceptable quality, and ad-
DISCUSSION—In a foil laminate structure a void, commonly called a
equately contains the product; (2) characteristics of the seal,
pinhole or foil pinhole, may only be in the foil layer without an opening which ensures that it prevents the ingress of microorganisms
through all laminate layers. under specified conditions.
porous packaging material—a material used in medical seal strength—mechanical capacity of the seal to withstand
packaging which is intended to provide an environmental force.
and biological barrier, while allowing sufficient air flow to be DISCUSSION—The measured seal strength will be impacted by the
used in gaseous sterilization methods (for example, EtO, mechanical properties of the sealed material(s) (for example. the
steam, gas plasma). bending force of the sealed material(s), elongation of the material(s),
and/or breaking or tearing of the material(s)) and will vary depending
preformed sterile barrier system—sterile barrier system that on the peeling tail angle.
is supplied partially assembled for filling and final closure or seam—a noncontinuous joint of two or more surfaces of sheet
sealing (for example, pouches, bags, and open reusable material such as made by stitching, spot adhesions, or
containers). intermittent fusion.
primary packaging, n—the first wrap or containment of the solution coating—in flexible barrier materials, (1) a process
contents. in which a substrate is covered with a homogeneous solution
primary barrier packaging, n—the first level of packaging containing the coating material, followed by removal of the
that provides environmental protection to the package con- (usually organic) solvent(s). (2) Also, the product resulting
tents as well as protection to the environment from the from such a process.
package contents: (1) gas, vapor, humidity, liquid, microbial,
spitting, v—dispensing of a low dose of product when both
or light resistant packaging that controls or eliminates the
product and air are dispensed resulting in the pump gener-
amount of those environmental constituents that pass into or
ating a distinctive spitting noise.
out of a package; (2) a porous package preventing the
passage of microorganisms that might contaminate the spray particles/droplets, n—the spherically-shaped liquid ob-
contents of the package. jects that are the result of the atomization process created by
a dispensing system with the size of these particles or
priming, v—the initial process of evacuating air from the
droplets usually expressed in microns.
mechanical pump dispenser and replacing it with product so
that the dispensing process may begin. spray pattern, n—pattern, preferably round, dispensed onto a
flat surface when this surface is positioned so that it will
protective packaging—(1) configuration of materials de-
intercept a spray at a 90 degree angle at a specific distance.
signed to prevent damage to the sterile barrier system and its
contents from the time of their assembly until the point of standard sprayer, n—generally, a finger-actuated, higher-
use; (2) any package or configuration of materials that output (greater than 500 µL) pump that delivers a coarser
eliminates external factors that may adversely affect the spray than a fine mist sprayer.
form, function, use, or appearance of the product through its
intended packaging life cycle. sterilant—an agent used to achieve commercial sterility.

retention of prime, n—ability of a pump to retain its prime and sterile—free of any viable microorganisms, either active or
dispense a full dose without re-priming after a period of dormant (Terminology D1129, D19).
non-use. sterile barrier system—minimum package that prevents in-
retortable—capable of withstanding specified thermal pro- gress of microorganisms and allows aseptic presentation of
cessing in a closed retort at temperatures above 100°C. the product at the point of use.
seal—the result of joining surfaces together to form a continu- sterilization compatibility—attributes of the packaging mate-
ous bond without skips or breaks in the pattern, over the rial and/or system that allow it to both withstand the
contact surface. For example, surfaces can be joined together sterilization process and attain the required conditions for
by the use of adhesives or thermal fusion. sterilization within the packaging system.
seal contamination—foreign matter in the seal area such as, streaming, v—dispensing of a product in the form of a jet or a
but not limited to, water, grease, or food. stream.
seal creep—the reduction in width of a seal due to a force stroke length, n—the total distance of travel for the mechani-
being exerted on it, such as a bulky product, pouch cal pump dispenser from where the mechanism of a pump
distortion, or internal air pressure. sits at rest to where it is fully depressed.

4
 F17 − 20
strokes to prime (STP), n—the total number of complete
actuations needed to obtain a full discharge of product on the
initial use of package.
terminal sterilization—process whereby product is sterilized
within its sterile barrier system.
thermal processing—the application of heat to achieve a
reduced level of microbiological activity.
transparentization—an increase in light transmission through
a normally opaque material (such as Tyvek) due to effects of
excessive heat and/or pressure.
volatile extractables— for purposes of the ASTM tests for
volatile extractables and nonvolatile extractables, volatiles
shall be defined as those compounds that give more than
50 % recovery in studies using the applicable volatile
extractables method; (2) in microwave packaging, those
chemical species that are released in the vapor state from
microwave food packaging under simulated use conditions
and are detected using an applicable volatile extracables
method.
FIG. 2 Lotion Pump Dispenser
PARTS OF A FINGER-ACTUATED MECHANICAL
PUMP DISPENSER
(See Fig. 1 and Fig. 2.) closure or screw cap, n—a fitment that attaches the pump to
the container.
actuator, button, or spray head, n—the fingerpad that the
consumer depresses to dispense product. dip tube, n—a tube which provides passage of the product
from the container to the pump system.
ball or spherical valve, n—depending on the design of the
pump, it may be used as the upper or lower valve, or both. hood or dust cap, n—a protective cap placed over the actuator
to guard against inadvertent dispensing.
body, housing, or accumulator, n—the primary chamber for
creating the positive and negative pressure during the insert or orifice cup, n—the mechanical break-up component
pumping action. that forces product to flow in a swirl pattern out of the exit
orifice in order to produce a fine mist.
liner or external gasket, n—a ring-shaped sealing component
made of a deformable material used to make a pressure-tight
joint between the pump and container.
lower valve or seal valve, n—a valve that restricts the flow of
product down the dip tube during the pressurization stage
and promotes the flow of product from the container into the
body during the filling stage.
piston, n—a sliding component that helps pressurize the
product during actuation along with transfer of the product
from the body to the exit orifice in the actuator.
spring, n—used primarily to return the piston mechanism for
filling the body; however, the spring may also control the
opening pressure of the upper valve.
stem, n—for some pump designs, a means to connect the
actuator to the piston.
turret or collar, n—a fitment that secures the body to the
closure.
upper valve or poppet, n—a valve that controls the flow of
product out the exit orifice during the pressurization stage of
the liquid and restricts the flow of product so that negative
FIG. 1 Fine Mist Pump Dispenser pressure may be created during the filling stage.

5
 F17 − 20
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