ASTM F3004-13

Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound

SIGNIFICANCE AND USE
5.1 This method allows for the evaluation of seal quality by passing an ultrasound signal through the sealed area of a package or item. Poorly sealed areas will not transmit as much ultrasonic energy as properly sealed areas.  
5.2 This method relies on quantitative analysis of ultrasound signal strength, providing a non-subjective approach to assessing package seal quality and detecting defects.  
5.3 This technique has been used for inspecting a variety of materials including flexible pouch seals, rigid tray seals and other packaging components such as affixed valves. The precision and bias for any specific package and seal configuration needs to be individually determined and validated.  
5.4 The C-Scan approach is useful for laboratory applications or off-line seal inspection. The L-Scan approach can be used for on-line, real time inspection of seal quality. The sensitivity of either approach to detect a given defect size and level of severity needs to be individually determined.  
5.5 Sound waves propagate at different speeds through different materials generally moving faster through more dense materials. The acoustic impedance (expressed as g/cm2·μs) is the product of density (g/cm3) and velocity (cm/μs). Of particular importance is the extreme difference between the impedance of air and that of any solid material. Any gap or poorly bonded area can be readily detected.    
Material  
Velocity
(cm/μsec)  
Density
(g/cm3)  
Acoustic
Impedance
(g/cm2-μsec)  
Air (20°C, 1 bar)  
0.0344  
0.00119  
0.000041  
Water (20°C)  
0.148  
1.0  
0.148  
Polyethylene  
0.267  
1.1  
0.294  
Aluminum  
0.632  
2.7  
1.710
SCOPE
1.1 This standard method describes the technology and testing procedures that can be used to detect seal defects in the size range of 1 mm and characterize seal quality in a variety of packaging styles using airborne ultrasound technology.  
1.2 This test method does not purport to be the only method for measurement of seal quality.  
1.3 Heat seals and other package components can be tested in flexible, semi-rigid and rigid packages. Only the precision and bias for flexible package seals were evaluated in a recent ILS included in the method. The precision and bias for any specific package needs to be individually determined.  
1.4 On-line, real time inspection of seals can be considered particularly in the L-Scan mode.  
1.5 This method provides a non-destructive, quantitative, non-subjective approach to flexible package seal inspection.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Jul-2013
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.40 - Package Integrity

Relations

• Referred By: ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• Effective Date: 01-Aug-2013

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3004 − 13
StandardTest Method for
Evaluation of Seal Quality and Integrity Using Airborne
Ultrasound
This standard is issued under the fixed designation F3004; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Terminology
1.1 This standard method describes the technology and 3.1 Definitions:
testing procedures that can be used to detect seal defects in the 3.1.1 acoustic impedance—the product of a material’s den-
sizerangeof1mmandcharacterizesealqualityinavarietyof sity and its acoustic velocity.
packaging styles using airborne ultrasound technology.
3.1.2 airborne ultrasound—non-contact,non-destructiveul-
trasound technology that allows materials to be scanned and
1.2 Thistestmethoddoesnotpurporttobetheonlymethod
analyzed without physical contact with the transducers. No
for measurement of seal quality.
coupling is used other than air.
1.3 Heat seals and other package components can be tested
3.1.3 ultrasonic attenuation—the decay rate of the wave as
in flexible, semi-rigid and rigid packages. Only the precision
it propagates through a material. It is the combined effect of
and bias for flexible package seals were evaluated in a recent
scattering and absorption.
ILS included in the method. The precision and bias for any
specific package needs to be individually determined.
3.1.4 ultrasound—sound with frequencies greater than the
upper limit of human hearing which is approximately 20 kHz.
1.4 On-line, real time inspection of seals can be considered
Typical industrial applications use much higher frequencies in
particularly in the L-Scan mode.
the 1–100 MHz range.
1.5 This method provides a non-destructive, quantitative,
3.1.5 ultrasound C-Scan—multiple L-Scans which accumu-
non-subjective approach to flexible package seal inspection.
lates data to describe an area of interest in both X and Y
1.6 The values stated in SI units are to be regarded as
dimensions.
standard. No other units of measurement are included in this
3.1.6 ultrasound L-Scan—a single linear scan across one
standard.
direction over the area of interest.
1.7 This standard does not purport to address all of the
4. Summary of Test Method
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4.1 Ultrasound has been used for inspecting a wide variety
priate safety and health practices and determine the applica-
of materials as well as human health issues, based on sending
bility of regulatory limitations prior to use.
and receiving ultrasonic sound waves. Airborne Ultrasound
(ABUS) is a non-contact ultrasound technology that allows
2. Referenced Documents
packages to be scanned and analyzed without making any
2.1 ASTM Standards: contact with the ultrasonic transducers. Unlike contact
E177Practice for Use of the Terms Precision and Bias in ultrasound, ABUS does not use liquid or gel coupling to
ASTM Test Methods propagate sound. It may be critical to production processes to
E691Practice for Conducting an Interlaboratory Study to analyze a bond without changing the characteristics of the
Determine the Precision of a Test Method package or product in any way which may affect salability.
ABUS is capable of testing packaging where continuous and
complete bonding between two materials is essential or, if the
bond is limited, the degree of bonding.
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on
4.2 ABUS is similar to most ultrasound applications in
Package Integrity.
principle; however it uses air to propagate ultrasonic waves.
Current edition approved Aug. 1, 2013. Published September 2013. DOI:
10.1520/F3004-13.
The ABUS technology uses the transmission of ultrasonic
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
waves to create a representative data image, allowing for
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
quantitative evaluation of the quality of bonded materials. It
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. has the ability to identify the size and location of defects, as
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3004 − 13
well as problems with bond integrity that may or may not containing these defects. The ability of these artificially pro-
immediately result in leaks. The ultrasonic signal is translated duceddefectstosimulatedefectswhichmaybeencounteredin
by a signal processor into a quantitative data image that refers actual production must be determined.
to signal strength continuously measured by the receiving
7. Apparatus
ultrasonic transducer during scanning or while a sample seal
moves relatively between them. The signal strength is mea- 7.1 The apparatus consists of:
suredinarelativevalue,fromstrongestsignalcapableofbeing
7.1.1 A transducer to provide an ultrasonic signal.
transmitted through the air to no signal capable of being 7.1.2 Air gap separating the signal and detection transduc-
transmittedthroughtheair(abovethenaturalnoiselevelofthat
ers.
frequency). Based on this scale of sound measurement, quan- 7.1.3 Adetection transducer to measure the intensity of that
titative data representations of the material being scanned can
signal after passing through the air gap.
be used to characterize the condition of certain materials, most 7.1.4 Ameanstoholdandtransportthatsamplebetweenthe
specifically whether two layers of material are appropriately
two transducers.
bonded together. 7.1.5 An Ultrasonic instrument, which integrates the hard-
ware and software required for analyzing ultrasonic wave
4.3 The technique and instrumentation is fundamentally
phenomena.
very simple. An ultrasonic transducer is used to produce a
7.1.6 Acomputersystemtocollectdataastotheintensityof
signal which is subsequently passed through a sample. The
the signal at any XY location and convert that data into a
transmitted signal is then received and processed by an
format useful to the investigator. A wide variety of data
ultrasonic signal processor. The signal strength, after passing
presentations are possible.
throughthesampleundertestandairgaps,isthencomparedto
the strength when a non-defective sample is tested.
8. Reagents and Materials
8.1 No reagents or other items are used.
5. Significance and Use
5.1 This method allows for the evaluation of seal quality by
9. Precautions
passing an ultrasound signal through the sealed area of a
9.1 No materials not intended to be tested, objects or body
package or item. Poorly sealed areas will not transmit as much
parts should be placed between the transducers or otherwise
ultrasonic energy as properly sealed areas.
block mechanical moving parts of the test instrument.
5.2 Thismethodreliesonquantitativeanalysisofultrasound
10. Sampling
signal strength, providing a non-subjective approach to assess-
ing package seal quality and detecting defects.
10.1 No special sampling rules apply.
5.3 This technique has been used for inspecting a variety of
11. Test Specimens
materials including flexible pouch seals, rigid tray seals and
11.1 Test specimens shall be representative of the material
other packaging components such as affixed valves. The
being tested and shall be free of defects, including wrinkles,
precision and bias for any specific package and seal configu-
creases, and pinholes, unless these are a characteristic of the
ration needs to be individually determined and validated.
material being tested.
5.4 The C-Scan approach is useful for laboratory applica-
11.2 The specimen size and configuration shall conform to
tions or off-line seal inspection. The L-Scan approach can be
used for on-line, real time inspection of seal quality. The the requirements of the specific instrument used and the item
under test.
sensitivity of either approach to detect a given defect size and
level of severity needs to be individually determined.
12. Calibration
5.5 Sound waves propagate at different speeds through
12.1 The instrument is calibrated in conformance to the
differentmaterialsgenerallymovingfasterthroughmoredense
2 instrument manufacturers’instructions.
materials. The acoustic impedance (expressed as g/cm ·µs) is
the product of density (g/cm ) and velocity (cm/µs). Of
13. Conditioning
particular importance is the extreme difference between the
13.1 Typically, no sample conditioning is required.
impedance of air and that of any solid material. Any gap or
poorly bonded area can be readily detected.
14. Procedure
Acoustic
Velocity Density
14.1 Each specific instrument will be operated in accor-
Material Impedance
(cm/µsec) (g/cm )
(g/cm -µsec)
dance with the instrument manufacturers’ instructions. Each
Air (20°C, 1 bar) 0.0344 0.00119 0.000041
will follow the same general steps as outlined below.
Water (20°C) 0.148 1.0 0.148
14.1.1 Thesampleisheldinafixturewiththepositionofits
Polyethylene 0.267 1.1 0.294
Aluminum 0.632 2.7 1.710
seal or area of interest noted.
14.1.2 Thesampleismovedataconstantspeedbetweenthe
6. Interferences
generating and receiving transducers by either moving the
6.1 The sensitivity of the system to detect very slight seal sample relative to the fixed transducers or by moving the
defects needs to be established with mocked up samples transducers relative to the fixed sample.
F3004 − 13
14.1.3 The X-Y position is recorded along with the corre- 45 Samples (consisting of 15 non-defective + 30 defective)
sponding acoustic attenuation or signal strength. (a)Non-defective Seal – 15 replicates
14.1.4 The rate that the sample is tested shall be based on (b)1 mm Channel – 5 replicat
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