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ASTM F1884-04(2011)

(Test Method)

Standard Test Method for Determining Residual Solvents in Packaging Materials

Standard Test Method for Determining Residual Solvents in Packaging Materials

SIGNIFICANCE AND USE
This test method is intended to measure volatile organic compounds that are emitted from packaging materials under high-temperature conditions.
This test method may be useful in assisting in the development and manufacture of packaging materials having minimal retained packaging ink/adhesive solvents.
Modification of this procedure by utilizing appropriate qualitative GC detection devices such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile organics of unknown identity.
SCOPE
1.1 This test method covers determination of the amount of residual solvents released from within a packaging material contained in a sealed vial under a given set of time and temperature conditions and is a recommended alternative for Test Method F151.
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are retained in packaging materials.
1.3 The analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate studies on the solvents of interest. The analyst is referred to Practice E260 for guidance.
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy or other suitable techniques in conjunction with this test method.
1.5 Sensitivity of this test method in the determination of the concentration of a given retained solvent must be determined on a case by case basis due to the variation in the substrate/solvent interaction between different types of samples.
1.6 This test method does not address the determination of total retained solvents in a packaging material. Techniques such as multiple headspace extraction can be employed to this end. The analyst is referred to the manual supplied with the GC-Autosampling system for guidance.
1.7 The values stated in SI units are to be regarded as the standard.
1.8 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-Mar-2011
ICS
55.040 - Packaging materials and accessories
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.15 - Chemical/Safety Properties
Current Stage
Ref Project

Relations

Replaces
ASTM F1884-04 - Standard Test Method for Determining Residual Solvents in Packaging Materials
Effective Date
01-Apr-2011
Referred By
ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
Effective Date
01-Apr-2011
Referred By
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Apr-2011

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ASTM F1884-04(2011) - Standard Test Method for Determining Residual Solvents in Packaging MaterialsASTM F1884-04(2011) - Standard Test Method for Determining Residual Solvents in Packaging Materials
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ASTM F1884-04(2011) - Standard Test Method for Determining Residual Solvents in Packaging Materials
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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: F1884 − 04 (Reapproved 2011)
Standard Test Methods for
1
Determining Residual Solvents in Packaging Materials
This standard is issued under the fixed designation F1884; 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 2. Referenced Documents
2
1.1 This test method covers determination of the amount of 2.1 ASTM Standards:
residual solvents released from within a packaging material E177Practice for Use of the Terms Precision and Bias in
contained in a sealed vial under a given set of time and ASTM Test Methods
temperature conditions and is a recommended alternative for E260Practice for Packed Column Gas Chromatography
Test Method F151. E691Practice for Conducting an Interlaboratory Study to
Determine the Precision of a Test Method
1.2 This test method covers a procedure for quantitating
F151Test Method for Residual Solvents in Flexible Barrier
volatile compounds whose identity has been established and
3
Materials (Withdrawn 2004)
which are retained in packaging materials.
1.3 The analyst should determine the sensitivity and repro-
3. Terminology
ducibility of the method by carrying out appropriate studies on
3.1 Definitions:
thesolventsofinterest.TheanalystisreferredtoPracticeE260
2 2 6 2
3.1.1 ream—3000 ft = 278.7 m = 27.87×10 cm .
for guidance.
3.1.2 retained solvents—those chemical species, which are
1.4 For purposes of verifying the identity of or identifying
retained by packaging material and can be detected in the
unknown volatile compounds the analyst is encouraged to
headspace of sealed sample vials under conditions of elevated
incorporate techniques such as gas chromatography/mass
temperature.
spectroscopy, gas chromatography/infrared spectroscopy or
other suitable techniques in conjunction with this test method.
4. Summary of Test Method
1.5 Sensitivity of this test method in the determination of
4.1 Retained volatile organic solvents are determined by
the concentration of a given retained solvent must be deter-
subjectingthepackagingmaterialtoelevatedtemperaturesina
mined on a case by case basis due to the variation in the
headspace sampling system with subsequent gas chromatogra-
substrate/solvent interaction between different types of
phy of the headspace and detection using a suitable detection
samples.
device such as a flame ionization detector (FID).
1.6 This test method does not address the determination of
4.2 Volatile components can then be quantified by compari-
total retained solvents in a packaging material. Techniques
son with standards of known concentration.
such as multiple headspace extraction can be employed to this
4.3 Qualitative analysis may be carried out on a gas chro-
end. The analyst is referred to the manual supplied with the
matograph (GC) coupled to an appropriate detector capable of
GC-Autosampling system for guidance.
compound detection / identification, such as a mass spectrom-
1.7 The values stated in SI units are to be regarded as the
eter or infrared detector.
standard.
1.8 This standard does not purport to address all of the
5. Significance and Use
safety concerns, if any, associated with its use. It is the
5.1 This test method is intended to measure volatile organic
responsibility of the user of this standard to establish appro-
compounds that are emitted from packaging materials under
priate safety and health practices and determine the applica-
high-temperature conditions.
bility of regulatory limitations prior to use.
1 2
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Barrier Packagingand is the direct responsibility of Subcommittee F02.15 on contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Chemical/Safety Properties. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved April 1, 2011. Published April 2011. Originally the ASTM website.
3
approved in 1998. Last previous edition approved in 2004 as F1884–04. DOI: The last approved version of this historical standard is referenced on
10.1520/F1884-04R11. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1884 − 04 (2011)
5.2 This test method may be useful in assisting in the 7.2.2 If desired, water may be used as the diluent for the
development and manufacture of packaging materials having standard. The solvents are diluted in 1 L of water, typically 2
minimal retained packaging ink/adhesive
...

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SCOPE
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Standard Test Methods for Determining Residual Solvents in Packaging Materials

SIGNIFICANCE AND USE
5.1 This test method is intended to measure volatile organic compounds that are emitted from packaging materials under high-temperature conditions.  
5.2 This test method may be useful in assisting in the development and manufacture of packaging materials having minimal retained packaging ink/adhesive solvents.  
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1.1 This test method covers determination of the amount of residual solvents released from within a packaging material contained in a sealed vial under a given set of time and temperature conditions and is a recommended alternative for Test Method F151.  
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5.2 The procedures presented in this test method allow the user to carry out package and seal integrity testing with sufficient sensitivity to quantify seals in the previously defined moderate to fine seal ranges.  
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SCOPE
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1.1.3 Package/product-specific test fixtures.  
1.1.4 Most applications of helium leak detection are destructive, in that helium needs to be injected into the package after the package has been sealed. The injection site then needs to be sealed/patched externally, which often destroys its saleability. Alternatively, if helium can be incorporated into the headspace before sealing, the method can be non-destructive because all that needs to be accomplished is to simply detect for helium escaping the sealed package.  
1.2 Two procedures are described; however the supporting data in Section 14 only reflects Procedure B (Vacuum Mode). The alternative, Sniffer Mode, has proven to be a valuable procedure for many applications, but may have more variability due to exactly the manner that the operator conducts the test such as whether the package is squeezed, effect of multiple small leaks compared to fewer large leaks, background helium concentration, package permeability and speed at which the scan is conducted. Further testing to quantify this procedure’s variability is anticipated, but not included in this version.  
1.2.1 Procedure A: Sniffer Mode—the package is scanned externally for helium escaping into the atmosphere or fixture.  
1.2.2 Procedure B: Vacuum Mode—the helium containing package is placed in a closed fixture. After drawing a vacuum, helium escaping into the closed fixture (capture volume) is detected. Typically, the fixtures are custom made for the specific package under test.  
1.3 The sensitivity of the method can range from the detection of:  
1.3.1 Large leaks—10-2 Pa·m 3/s to 10-5 Pa·m3/s (10–1 cc/sec/atm to 10-4 cc/sec/atm).  
1.3.2 Moderate leaks—10-5 Pa·m 3/s to 10-7 Pa·m3/s (10-4 cc/sec/atm to 10-6 cc/sec/atm).  
1.3.3 Fine leaks—10-7 Pa·m 3/s to 10-9 Pa·m3/s (10-6 cc/sec/atm to 10-8 cc/sec/atm).  
1.3.4 Ultra-Fine leak—10-9 Pa·m 3/s to 10-11 Pa·m3/s (10-8 cc/sec/atm to 10-10 cc/sec/atm).
Note 1: Conversion from cc/sec/atm to Pa·m3/s is achieved by multiplying by 0.1.  
1.4 The terms large, moderate, fine and ultra-fine are relative terms only and do not imply the acceptability of any leak rate. The individual application dictates the level of integrity needed. For many packaging applications, only “large leaks” are considered unacceptable and the ability to detect smaller leaks is immaterial. All leak rates referred...

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