ASTM F3375-19

Standard Test Method for Assessing Non-Metered Restricted Delivery Systems for Liquid Consumer Products

SIGNIFICANCE AND USE
5.1 Despite child-resistant packaging requirements for most potentially harmful liquid consumer products, each year tens of thousands of young children are evaluated in emergency departments for potential poisoning from liquid consumer products. Products that use reclosable safety packaging rely on users to resecure the child-resistant closure fully after each use. If the closure is not fully secured or a child opens the closure, the entirety of the product contents is immediately accessible. Restricted delivery systems are a type of packaging for medications and other liquid consumer products designed to limit the amount of product that is accessible even after the primary closure is removed.  
5.2 This test method can be used to provide quantitative assessment of restricted delivery systems for liquid consumer products. This test method outlines three types of mechanical test procedures to simulate methods young children may use when attempting to access liquid contents from a container. To evaluate the efficacy of restricted delivery systems, tests are conducted with the primary closure removed and under conditions approximating intended use of the products. Instruction for use for the intended product should be used when preparing the samples for testing; for example, storage temperature, shaking of product, and use of associated dispensing devices when applicable.
SCOPE
1.1 This test method covers assessment of non-metered restricted delivery system characteristics so that they can be evaluated to a standard that signifies efficacy in limiting accessibility of liquid contents to young children.  
1.2 This test method provides general test conditions for the determination of flow control of liquids by restricted delivery systems using mechanical testing to simulate methods that may be used to access liquid consumer products by young children.  
1.3 The test parameters provided within this test method are estimates based on existing literature and experience. The estimated values are intended to allow comparison of performance characteristics across different restricted delivery systems.  
1.4 This test method applies to liquids packaged in reclosable containers.
Note 1: Since there are many variables that may affect release of liquid (for example, rigidity of container, viscosity of liquid contents, or variation in test equipment), it is important that the entire restricted delivery system is tested together as intended for use while using the same or similar testing equipment. This test method does not address other product characteristics that might be affected by use of restricted delivery systems (for example, uniformity of active ingredient throughout duration of use).  
1.5 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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.

General Information

• Status: Published
• Publication Date: 14-Apr-2019
• ICS: 55.100 - Bottles. Pots. Jars
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.30 - Mechanical Dispensers

Relations

• Refers: ASTM E177-14 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-May-2014
• Refers: ASTM E691-13 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-May-2013
• Refers: ASTM E177-13 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-May-2013
• Refers: ASTM D7778-12 - Standard Guide for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 15-Apr-2012
• Refers: ASTM E691-11 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-Nov-2011
• Refers: ASTM E177-10 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Oct-2010
• Refers: ASTM E691-08 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-Oct-2008
• Refers: ASTM E177-08 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Oct-2008
• Refers: ASTM E177-06b - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 15-Nov-2006
• Refers: ASTM E177-06a - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Nov-2006
• Refers: ASTM E691-05 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-Nov-2005
• Refers: ASTM E177-06 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Nov-2004
• Refers: ASTM E177-04 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Nov-2004
• Refers: ASTM E177-04e1 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Nov-2004
• Refers: ASTM E177-90a(2002) - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 10-Jan-2002

Overview

ASTM F3375-19 is the internationally recognized standard test method for assessing non-metered restricted delivery systems used in the packaging of liquid consumer products. Published by ASTM International, this standard provides a framework for evaluating packaging designed to restrict the uncontrolled release and accessibility of liquid products, particularly by young children. The method addresses the effectiveness of restricted delivery systems once the primary child-resistant closure is removed, helping to enhance child safety and reduce incidents of accidental poisoning.

Key Topics

• Purpose of Assessment: The standard emphasizes the importance of limiting children’s access to potentially hazardous liquid consumer products, even in the absence of actively engaged child-resistant packaging.
• Mechanical Test Procedures: Three main types of mechanical tests are outlined to simulate ways children might attempt to extract contents:
  • Deceleration (Swing Test): Mimics shaking the container.
  • Application of Force (Squeeze Test): Simulates squeezing the container.
  • Application of Negative Pressure (Vacuum Test): Imitates sucking from the container.
• Testing Conditions: Procedures are to be conducted under conditions approximating actual intended use, taking into account storage temperatures, product handling (e.g. shaking), and associated dispensing devices.
• Quantitative Evaluation: The method provides a means to objectively compare the performance of different restricted delivery systems by measuring the amount of liquid released during testing.

Applications

The ASTM F3375-19 test method has broad practical applications in the consumer products and packaging industries, particularly where the goal is to improve child safety and manage regulatory requirements:

• Consumer Product Manufacturers: Ensures that packaging for liquid medicines, household cleaners, and other chemicals meets safety expectations by restricting the flow of contents after closure removal.
• Packaging Designers and Developers: Provides a benchmarking tool for evaluating innovations in restricted delivery systems, enabling comparison and optimization of design features.
• Quality Assurance and Compliance: Used by testing laboratories and regulatory agencies to validate the performance of restricted delivery systems as part of compliance with child safety regulations.
• Risk Mitigation: Helps prevent large-scale access to hazardous or potentially harmful liquids by young children, even if child-resistant mechanisms are bypassed or improperly secured.
• Standardization and Certification: Supports the harmonization of packaging safety standards across international markets, facilitating global trade in consumer packaged goods.

Related Standards

ASTM F3375-19 functions within a broader framework of packaging safety and mechanical testing standards, including:

• ASTM D7778: Guide for conducting interlaboratory studies to determine test method precision.
• ASTM E177: Practice for using the terms precision and bias in ASTM test methods.
• ASTM E691: Practice for conducting interlaboratory studies to determine the precision of a test method.

These related standards support the consistent application, reliability, and reproducibility of test procedures for packaging systems, strengthening confidence in child safety packaging across the industry.

Keywords: ASTM F3375-19, restricted delivery system, child safety, liquid consumer product packaging, packaging testing, mechanical testing, consumer safety standards, non-metered delivery system, poisoning prevention, standard test method.

Standards Content (Sample)

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: F3375 − 19
Standard Test Method for
Assessing Non-Metered Restricted Delivery Systems for
Liquid Consumer Products
This standard is issued under the fixed designation F3375; 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 ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This test method covers assessment of non-metered
mendations issued by the World Trade Organization Technical
restricted delivery system characteristics so that they can be
Barriers to Trade (TBT) Committee.
evaluated to a standard that signifies efficacy in limiting
accessibility of liquid contents to young children.
2. Referenced Documents
1.2 This test method provides general test conditions for the 2
2.1 ASTM Standards:
determination of flow control of liquids by restricted delivery
D7778 Guide for Conducting an Interlaboratory Study to
systemsusingmechanicaltestingtosimulatemethodsthatmay
Determine the Precision of a Test Method
be used to access liquid consumer products by young children.
E177 Practice for Use of the Terms Precision and Bias in
1.3 The test parameters provided within this test method are ASTM Test Methods
estimates based on existing literature and experience. The E691 Practice for Conducting an Interlaboratory Study to
estimated values are intended to allow comparison of perfor- Determine the Precision of a Test Method
mance characteristics across different restricted delivery sys-
3. Terminology
tems.
3.1 Definitions of Terms Specific to This Standard:
1.4 This test method applies to liquids packaged in reclos-
3.1.1 restricted delivery system, n—packaging system de-
able containers.
signed to limit the amount of contents that can be accessed by
NOTE 1—Since there are many variables that may affect release of
liquid (for example, rigidity of container, viscosity of liquid contents, or young children (<6 years of age).
variation in test equipment), it is important that the entire restricted
3.1.1.1 Discussion—For liquid consumer products, the re-
delivery system is tested together as intended for use while using the same
stricted delivery system includes the liquid contents, container
or similar testing equipment. This test method does not address other
(for example, bottle), and any additional container components
product characteristics that might be affected by use of restricted delivery
to limit flow (for example, components attached to the con-
systems (for example, uniformity of active ingredient throughout duration
of use). tainer orifice, including press-in bottle adapters).
1.5 Units—The values stated in either SI units or inch-
4. Summary of Test Method
pound units are to be regarded separately as standard. The
4.1 Three mechanical test procedures are used to assess
values stated in each system may not be exact equivalents;
efficacy of restricted delivery systems in limiting unintentional
therefore,eachsystemshallbeusedindependentlyoftheother.
access to liquid consumer products by young children. Test
Combining values from the two systems may result in noncon-
procedures are intended to simulate methods that young
formance with the standard.
children may use to access liquid products from containers.All
1.6 This standard does not purport to address all of the
components of the restricted delivery system are tested to-
safety concerns, if any, associated with its use. It is the
gether and the amount of liquid released is recorded for each
responsibility of the user of this standard to establish appro-
procedure.
priate safety, health, and environmental practices and deter-
4.1.1 Deceleration—To simulate shaking the container;
mine the applicability of regulatory limitations prior to use.
“swing test.”
1.7 This international standard was developed in accor-
4.1.2 Application of Force—To simulate squeezing the con-
dance with internationally recognized principles on standard-
tainer; “squeeze test.”
This test method is under the jurisdiction ofASTM Committee F02 on Primary
Barrier Packaging and is the direct responsibility of Subcommittee F02.30 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Mechanical Dispensers. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Current edition approved April 15, 2019. Published June 2019. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F3375–19. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3375 − 19
4.1.3 Application of Negative Pressure—To simulate suck- container to be dropped in a controlled pendulum swing in a
ing from the container: “vacuum test.” 90° downward arc to a sudden stop. The apparatus should be
sufficiently rigid to handle swings of containers intended for
5. Significance and Use
liquid consumer products without excessive motion or vibra-
tionandwithminimalfriction.Theapparatusshouldpermitthe
5.1 Despite child-resistant packaging requirements for most
potentiallyharmfulliquidconsumerproducts,eachyeartensof container to be securely loaded in an upright position before
thousands of young children are evaluated in emergency testing and ending in a fully inverted position after the 90°
departments for potential poisoning from liquid consumer swing. The upright container should be firmly attached to the
products. Products that use reclosable safety packaging rely on apparatusbyarodof25 61cm[10 60.25in.]toapproximate
users to resecure the child-resistant closure fully after each use. the forearm length of a child (see Fig. 2).
If the closure is not fully secured or a child opens the closure,
6.2 Application of Force (Fig. 3)—The apparatus should
the entirety of the product contents is immediately accessible.
have an upright post that allows a 1.0 cm [0.375 in.] diameter
Restricted delivery systems are a type of packaging for
rod (cantilever) to be hinged to it. The rod should be 41.1 cm
medications and other liquid consumer products designed to
[16.2 in.] long from hinge to hang point and allow a 1.0 kg [2.2
limit the amount of product that is accessible even after the
lb] weight to be hung from the non-hinged end.The rod should
primary closure is removed.
be sufficiently rigid to resist flexing when the weight is hung
5.2 This test method can be used to provide quantitative from the end. The weight should be a one-piece design to help
assessment of restricted delivery systems for liquid consumer facilitate with the continuous application of force during the
products. This test method outlines three types of mechanical test. The container should be positioned under the rod at a
test procedures to simulate methods young children may use distance 10.2 cm [4 in.] from the hinged end of the rod. The
when attempting to access liquid contents from a container. To container should be either seated in a groove or block to keep
evaluate the efficacy of restricted delivery systems, tests are it from moving out of position during the test. The rod should
conducted with the primary closure removed and under con- be aligned with the midpoint of the container for the applica-
ditions approximating intended use of the products. Instruction tion of “squeezing.” Midpoint is defined as the position
for use for the intended product should be used when preparing halfway between the base of the container and shoulder where
the samples for testing; for example, storage temperature,
the body of the container meets the neck of the container. Note
shaking of product, and use of associated dispensing devices that the compression strength of a bottle may be impacted by
when applicable.
the material distribution and the parting line on the container,
i.e. where the two halves of the mold meet, for this reason the
6. Apparatus
position of the parting line should either be noted or positioned
6.1 Deceleration (Fig. 1)—The apparatus should permit the consistently during testing to reduce variation.
FIG. 1 Example Apparatus for Deceleration (Swing) Test
F3375 − 19
FIG. 2 Pendulum Arm Dimensions
FIG. 3 Example Critical Parameters for Application of Force (Squeeze) Apparatus
3 3
6.3 Application of Negative Pressure (Fig. 4)—The appara- ft /min), vacuum chamber (3-28 L or 0.1-1.0 ft ), inverted
tus should consist of a vacuum source (56-113 L/min or 2-4 sample holder, collection vessel, vacuum regulator, and gauge
F3375 − 19
FIG. 4 Example Apparatus for Negative Pressure (Vacuum) Test
(digital is preferred) (see Fig. 5). The sample holder and collection vessel (that is, vent hole) shall be provided (see Fig.
collection vessel may be combined into a single unit.Ameans 6). The apparatus should allow for the application of negative
of pressure equilibration between the vacuum chamber and the pressure for a specified time and the immediate release of the
FIG. 5 Example Vacuum and Gauge Setup for Negative Pressure Test
F3375 − 19
FIG. 6 Example Inverted Container Holder and Collection Container
vacuum after the test period. The vacuum gauge shall be 8. Test Conditions
laboratory quality with a full-scale range from 0 to 100 kPa [0
8.1 Temperature—Tests should be conducted within the
to 29.5 in. Hg] with minimum graduations no greater than 0.1
temperature range recommended for proper storage of the
kPa [0.03 in. Hg] and accuracy to within 2 %.
liquid contents. Test samples should be allowed to come to
equilibrium to the ambient test conditions and the temperature
7. Reagents
should be recorded.
7.1 Tests should be conducted with the liquid product for
8.2 Fill Capacity—The deceleration and application of
which the specific restricted delivery system is intended to be
used or a liquid of similar viscosity and other flow character- negative pressure tests should be conducted both with contain-
ers having one dose of liquid contents removed and containers
istics to the liquid product for which the delivery system is
intended to be used. having half of the product removed based on the label claim
F3375 − 19
capacity. The one dose removed should be based on the 10. Sample Selection and Preparation
smallest dose listed in the dosing instructions for the product.
10.1 Thenumberoftestspecimensshallbechosentopermit
The application of force test should only be conducted with
an adequate determination of representative performance.
containers with the one dose of liquid removed. Removal of
10.2 Test specimens should be representative of the in-
product (one dose and half) should be via the intended dosing
tended commercial components/products.
device when applicable.
10.3 The primary closure and any tamper-evident seal(s)
9. Test Parameters
should be removed before testing. Record the initial weight (in
9.1 Deceleration: Rod Length, Arc, and Number of Cycles grams) of each container after the primary closure and tamper-
(Fig. 1)—For the deceleration test, a container will be dropped evident seal(s) have been removed.
in a pendulum swing to an inverted position to simulate the
shaking of the container by a young child. The container will 11. Procedure
be slowly rotated from a 9:00 o’clock (270°) position to a
11.1 Deceleration:
12:00 o’clock (0°) position, taking approximately 5 s, until
11.1.1 Remove either one dose of liquid or half of the
gravity takes over the rotation to a sudden stop at the 3:00
intended contents from the container using the method of
o’clock (90°) position while achieving a downward swing of
intended use (for example, drawing into oral syringe, squeez-
Fig. 7 for positions.
90°. See
ing into dosing cup).
9.1.1 The container is left inverted for 5 s before returning
11.1.2 Record the weight of the container after the specified
the container to an upright position at the 9:00 o’clock (270°)
amount of liquid has been removed. If the restricted delivery
position. This is repeated for a total of five consecutive swings
system uses a self-sealing mechanism, allow time for resealing
with each swing taking approximately 10 s to complete.
and record the time from when the dose was removed to when
9.2 Application of Force: Magnitude of Force and Number
the sample was first tested.
of Cycles (Fig. 3 and Fig. 8)—To simulate the force with which
11.1.3 Slowly,takingapproximately5s,rotatethecontainer
a young child might squeeze a container, the application of 39
to the 12:00 o’clock (0°) position until gravity takes over the
6 1.5 N [8.8 lb 6 5.4 oz] should be used for the squeeze test.
rotation of the container to a sudden stop at the 3:00 o’clock
The test consists of one “squeeze” over a period of 5 s. The
(90°) position (see Fig. 1).
“squeeze” time is measured from the time the force is initially
11.1.4 Leave the container inverted for 5 s before returning
applieduntilitisremovedat5s.Theweightofthelevershould
the container to the 9:00 (270°) upright position.
be completely applied, that is, supported by t
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