ASTM D3861-22

Standard Test Method for Quantity of Water-Extractable Matter in Membrane Filters

SIGNIFICANCE AND USE
5.1 The presence of water-soluble extractables in membrane filters can create errors in test procedures employing membrane filters. However, these errors can be eliminated or significantly reduced if the quantity of water-soluble extractables of the specific membrane is previously determined. Certain membrane filter uses require specifications of maximum water-soluble extractable levels. This test method is intended to be a rapid test to determine the loss of water-soluble compounds such as plasticizers or wetting agents from filtration membranes. This test method is not designed to predetermine the performance of a filter, but is significant in determining the percent extractables of membranes from different sources and lot variations from a single source.
SCOPE
1.1 This test method covers the gravimetric determination of the water-extractable material present in membrane filters and is applicable over the complete concentration range of extractables.  
1.2 The analyst should be aware that collaborative data for a bias statement as required by Practice D2777 is not provided. See Section 11 for details.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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: 31-Oct-2022
• ICS: 23.100.60 - Filters, seals and contamination of fluids
• Technical Committee: D19 - Water
• Drafting Committee: D19.08 - Membranes and Ion Exchange Materials

Relations

• Refers: ASTM D1129-13(2020)e2 - Standard Terminology Relating to Water
• Effective Date: 01-May-2020
• Refers: ASTM D2777-12 - Standard Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water
• Effective Date: 15-Jun-2012
• Refers: ASTM D1129-10 - Standard Terminology Relating to Water
• Effective Date: 01-Mar-2010
• Refers: ASTM D2777-08 - Standard Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water
• Effective Date: 15-Jan-2008
• Refers: ASTM D1129-06a - Standard Terminology Relating to Water
• Effective Date: 01-Sep-2006
• Refers: ASTM D1129-06ae1 - Standard Terminology Relating to Water
• Effective Date: 01-Sep-2006
• Refers: ASTM D2777-06 - Standard Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water
• Effective Date: 15-Aug-2006
• Refers: ASTM D1193-06 - Standard Specification for Reagent Water
• Effective Date: 01-Mar-2006
• Refers: ASTM D1129-06 - Standard Terminology Relating to Water
• Effective Date: 15-Feb-2006
• Refers: ASTM D1129-04e1 - Standard Terminology Relating to Water
• Effective Date: 01-Mar-2004
• Refers: ASTM D1129-04 - Standard Terminology Relating to Water
• Effective Date: 01-Mar-2004
• Refers: ASTM D1129-03a - Standard Terminology Relating to Water
• Effective Date: 10-Aug-2003
• Refers: ASTM D2777-03 - Standard Practice for Determination of Precision and Bias of Applicable Methods of Committee D-19 on Water
• Effective Date: 10-Aug-2003
• Refers: ASTM D1129-03 - Standard Terminology Relating to Water
• Effective Date: 10-Mar-2003
• Refers: ASTM D1129-02a - Standard Terminology Relating to Water
• Effective Date: 10-Jul-2002

Overview

ASTM D3861-22 is the Standard Test Method for Quantity of Water-Extractable Matter in Membrane Filters, established by ASTM International. This method provides a gravimetric approach for determining the amount of water-soluble extractables present in membrane filters. Water-extractable materials such as plasticizers or wetting agents can impact filtration integrity and the accuracy of analytical procedures utilizing membrane filters. By quantifying these extractables, laboratories and manufacturers can better assess filter suitability, ensure product consistency, and comply with relevant technical and regulatory requirements.

Key Topics

• Water-Extractable Matter: Assesses the presence of compounds in membrane filters that dissolve in water and may interfere with testing processes.
• Gravimetric Analysis: Involves weighing preconditioned filters before and after exposure to boiling reagent-grade water, followed by precise drying and re-weighing.
• Control Filters: A simultaneously processed control membrane is used to account for weighing variations due to balance sensitivity or ambient moisture.
• Applicability: This test can be applied to the complete range of extractables and various membrane types, allowing assessment of products from different sources or lots.
• Precision and Quality Control: Emphasizes replicability and recognizes the inherent variability of microporous membranes; strict bias statements are not provided, but repeatability guidelines are included.
• Safety and Compliance: Observance of appropriate safety, health, and environmental practices is required, as the standard does not address specific hazards.

Applications

• Quality Assurance of Membrane Filters: Routine monitoring of extractable levels supports consistent manufacturing, helping filter producers meet technical specifications for critical applications.
• Laboratory Verification: Testing membrane filters before use in analytical or environmental laboratory procedures aids in identifying filters with excessive water-extractable matter that might compromise results.
• Regulatory Compliance: Specific filtration processes in pharmaceutical, food, water, or environmental testing sectors may necessitate documentation of water-extractable extractives to comply with industry or international quality standards.
• Product Comparison: Enables comparative analysis of membrane filters across manufacturers or lots to ensure uniformity and performance, particularly where extractable content must be controlled.
• Troubleshooting Analytical Procedures: Identifies filters that may introduce variables into sensitive assays due to leaching of water-soluble constituents.

Related Standards

• ASTM D1129: Terminology Relating to Water; defines terms used in water-testing standards.
• ASTM D1193: Specification for Reagent Water; sets quality requirements for the reagent-grade water used in extractables testing.
• ASTM D2777: Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water; provides guidance on evaluating the repeatability and reproducibility of water-testing methods.
• Membrane Filter Standards: Standards specifying performance requirements and testing of membrane filters in various industries may reference or require methods like ASTM D3861.

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Keywords: ASTM D3861-22, membrane filter, water-extractable matter, gravimetric test, laboratory filtration, extractables, filter quality, water testing, analytical quality control.

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: D3861 − 22
Standard Test Method for
Quantity of Water-Extractable Matter in Membrane Filters
This standard is issued under the fixed designation D3861; 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 3.1.1 For definitions of terms used in this test method, refer
to Terminology D1129.
1.1 This test method covers the gravimetric determination
of the water-extractable material present in membrane filters
4. Summary of Test Method
and is applicable over the complete concentration range of
4.1 The quantity of water-soluble extractables present in
extractables.
membrane filters is determined by immersing the preweighed
1.2 The analyst should be aware that collaborative data for
membraneinboilingreagentgradewaterforanextendedtime,
abiasstatementasrequiredbyPracticeD2777isnotprovided.
then drying and reweighing the membrane. A control mem-
See Section 11 for details.
brane is employed to eliminate weighing errors caused by
1.3 The values stated in SI units are to be regarded as
balance changes or changing moisture content of the mem-
standard. No other units of measurement are included in this
brane in the weighing procedures. Weight changes of the
standard.
control membrane are applied as a correction factor to the
weight change of the test membrane filters.
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
5. Significance and Use
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
5.1 Thepresenceofwater-solubleextractablesinmembrane
mine the applicability of regulatory limitations prior to use.
filterscancreateerrorsintestproceduresemployingmembrane
1.5 This international standard was developed in accor-
filters. However, these errors can be eliminated or significantly
dance with internationally recognized principles on standard-
reduced if the quantity of water-soluble extractables of the
ization established in the Decision on Principles for the
specific membrane is previously determined. Certain mem-
Development of International Standards, Guides and Recom-
brane filter uses require specifications of maximum water-
mendations issued by the World Trade Organization Technical
soluble extractable levels. This test method is intended to be a
Barriers to Trade (TBT) Committee.
rapid test to determine the loss of water-soluble compounds
such as plasticizers or wetting agents from filtration mem-
2. Referenced Documents
branes. This test method is not designed to predetermine the
performance of a filter, but is significant in determining the
2.1 ASTM Standards:
percent extractables of membranes from different sources and
D1129Terminology Relating to Water
lot variations from a single source.
D1193Specification for Reagent Water
D2777Practice for Determination of Precision and Bias of
6. Apparatus
Applicable Test Methods of Committee D19 on Water
6.1 Beaker, borosilicate glass, 300mL capacity.
3. Terminology
6.2 Forceps, stainless steel, unserrated tips.
3.1 Definitions:
6.3 Desiccator.
6.4 Drying Oven, with thermostatic control.
This test method is under the jurisdiction of ASTM Committee D19 on Water
6.5 Analytical Balance, sensitivity 0.01 mg.
and is the direct responsibility of Subcommittee D19.08 on Membranes and Ion
Exchange Materials.
6.6 α-Emitting Polonium Source (todischargestaticcharge
Current edition approved Nov. 1, 2022. Published December 2022. Originally
in balance).
approved in 1979. Last previous edition approved in 2011 as D3861–91 (2011)
which was withdrawn July 2020 and reinstated in November 2022. DOI: 10.1520/
6.7 Humidity-Controlled Room or Hood, for balance.
D3861-22.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on The “Staticmaster,” available from Nuclear Products Inc., El Monte, CA, has
the ASTM website. been found suitable for this purpose.
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D3861 − 22
6.8 Evaporating Dishes, glass, having sides or other means 10.2 Determine weight change of the control filter by
to keep test filters on the dish while drying. subtracting the initial weight W from the final weight W of
3 4
the control filter.
7. Reagents and Materials
10.2.1 If the weight change of the control filter exceeds 2
7.1 Purity of Water—Unless otherwise indicated, references
mg, the test should be rerun.
to water shall be understood to mean Type III reagent water
10.3 Determine corrected weight change of the test filter by
conforming to Specification D1193.
a
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