Cart (0)
  • No items in cart.
Subtotal
$0
There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.
Search book title
Enter keywords for book title search
Search book content
Enter keywords for book content search
Filters:
FORMAT
BOOKS
PACKAGES
EDITION
to
PUBLISHER
(1)
(316)
(569)
(43)
(234)
(969)
(643)
(1935)
(64)
(91921)
(54)
(535)
(117)
(28)
(20)
(19)
(92193)
(3)
(17)
(1)
(351)
(298)
(6023)
(239)
(16)
(5)
(1619)
(16)
(18)
(28)
(4)
 
(6)
(7)
(115)
(3)
(57)
(5)
(5)
(1)
(1)
(2)
(23)
(26)
(27)
(13)
(61)
(24)
(22)
(7)
(8)
(20)
(1)
(3)
(50)
(6)
(31)
CONTENT TYPE
 Act
 Admin Code
 Announcements
 Bill
 Book
 CADD File
 CAN
 CEU
 Charter
 Checklist
 City Code
 Code
 Commentary
 Comprehensive Plan
 Conference Paper
 County Code
 Course
 DHS Documents
 Document
 Errata
 Executive Regulation
 Federal Guideline
 Firm Content
 Guideline
 Handbook
 Interpretation
 Journal
 Land Use and Development
 Law
 Legislative Rule
 Local Amendment
 Local Code
 Local Document
 Local Regulation
 Local Standards
 Manual
 Model Code
 Model Standard
 Notice
 Ordinance
 Other
 Paperback
 PASS
 Periodicals
 PIN
 Plan
 Policy
 Product
 Program
 Provisions
 Requirements
 Revisions
 Rules & Regulations
 Standards
 State Amendment
 State Code
 State Manual
 State Plan
 State Standards
 Statute
 Study Guide
 Supplement
 Technical Bulletin
 All
  • ASTM
    F2391-05 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
    Edition: 2005
    $93.60
    Unlimited Users per year

Description of ASTM-F2391 2005

ASTM F2391-05

Historical Standard: ASTM F2391-05 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas

SUPERSEDED (see Active link, below)




ASTM F2391

1. Scope

1.1 This test method includes several procedures that can be used for the measurement of overall package and seal barrier performance of a variety of package types and package forms, as well as seal/closure types. The basic elements of this method include:

1.1.1 Helium (employed as tracer gas),

1.1.2 Helium leak detector (mass spectrometer), and

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 procedures 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 Pam 3 /s to 10 -5 Pam 3 /s (10 -1 cc/sec/atm to 10 -4 cc/sec/atm).

1.3.2 Moderate leaks-10 -5 Pam 3 /s to 10 -7 Pam 3 /s (10 -4 cc/sec/atm to 10 -6 cc/sec/atm).

1.3.3 Fine leaks-10 -7 Pam 3 /s to 10 -9 Pam 3 /s (10 -6 cc/sec/atm to 10 -8 cc/sec/atm).

1.3.4 Ultra-Fine leak-10 -9 Pam 3 /s to 10 -11 Pam 3 /s (10 -8 cc/sec/atm to 10 -10 cc/sec/atm).

Note 1Conversion from cc/sec/atm to Pam 3 /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 to in this method are based on conversion of actual conditions (based on partial pressure of helium) to one atmosphere pressure differential and standard temperature conditions.

1.5 The method may have applicability to any package type:

1.5.1 Flexible,

1.5.2 Semi-rigid, or

1.5.3 Rigid.

1.6 The sensitivities reported in the supporting data for this method pertain to the detectability of helium emanating from the sample and are not a function of the packaging form.

1.7 The method is not applicable to breathable or porous packaging.

1.8 The results obtained can be qualitative, semi-quantitative or quantitative depending on the procedure used.

1.9 Test fixture design is not within the scope of this method except to note that different designs will be needed for different applications (which have different package types and package integrity requirements). Furthermore, the fixture selection and design will be based on where the testing is to be conducted within the manufacturing process (in other words, quality control versus research).

1.10 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.


2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D996 Terminology of Packaging and Distribution Environments

D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

D4991 Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method

E432 Guide for Selection of a Leak Testing Method

E479 Guide for Preparation of a Leak Testing Specification

E493 Test Methods for Leaks Using the Mass Spectrometer Leak Detector in the Inside-Out Testing Mode

E498 Test Methods for Leaks Using the Mass Spectrometer Leak Detector or Residual Gas Analyzer in the Tracer Probe Mode

E499 Test Methods for Leaks Using the Mass Spectrometer Leak Detector in the Detector Probe Mode

E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

E1603 Test Methods for Leakage Measurement Using the Mass Spectrometer Leak Detector or Residual Gas Analyzer in the Hood Mode

F17 Terminology Relating to Flexible Barrier Packaging

F1327 Terminology Relating to Barrier Materials for Medical Packaging

Other Documents

Co-authors include C. Moeckly, L. Nguyen, R. Gerth, W. Muangsiri, R. Scheire, D. M. Guazzo, L. Kirsch, G. Schmitt, A. Kirsch, M. Koch, T. Wertli, M. Lehman and G. Schramm.

Keywords

blister packaging; bottles; cartridges; flexible packaging; gas barrier performance; helium leak test; impermeable packaging (and materials); integrity monitoring; mass spectrometer; mass spectrometer leak test; mass spectrometer sensor; pass/fail criteria; pass/fail levels; package integrity monitoring; package integrity test; permeable packaging (and materials); pouch packaging; seal integrity monitoring; seal integrity test; sniffer probe leak test; sterility barrier performance; vacuum leak test; vapor barrier performance; rigid packaging; vials; Tracer gas method; Helium; Helium leak testing; Package integrity test; Seal integrity;


ICS Code

ICS Number Code 55.040 (Packaging materials and accessories)


DOI: 10.1520/F2391-05

ASTM International is a member of CrossRef.


The following editions for this book are also available...

This book also exists in the following packages...

Year Publisher Title Annual Price
VAR
ASTM
[+] $1,101.20 Buy
VAR
ASTM
[+] $7,461.55 Buy

Subscription Information

MADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.

 

Some features of MADCAD.com ASTM Standards Subscriptions are:

- Online access: With MADCAD.com’ s web based subscription service no downloads or installations are required. Access ASTM Standards from any browser on your computer, tablet or smart phone.

- Immediate Access: As soon as the transaction is completed, your ASTM Standards Subscription will be ready for access.

 

For any further information on MADCAD.com ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.

 

About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.

X