ASTM D7709-12
(Test Method)Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters
Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters
SIGNIFICANCE AND USE
The purpose of these test methods is to obtain reliable values for WVTR that can be used to discriminate among barrier packages for pharmaceutical products. These test methods will establish a WVTR value that represents the water vapor transmission of the container closure system being evaluated. They are intended for use in evaluating or comparing, or both, the water vapor barrier performance of alternative packages for use in packaging of pharmaceutical products.
While these methods were developed for a specific, limited application, they should be suitable for most types and sizes of consumer packages.
SCOPE
1.1 The three test methods described herein are for measurement of water vapor transmission rates (WVTRs) of high-barrier multiple-unit containers (bottles), high-barrier single-unit containers (blisters), and quasi-barrier single-unit containers used for packaging pharmaceutical products. The containers are tested closed and sealed. These test methods can be used for all consumer-sized primary containers and bulk primary containers of a size limited only by the dimensions of the equipment and the weighing capacity and sensitivity of the balance.
1.2 These test methods are intended to be of sufficient sensitivity and precision to allow clear discrimination among the levels of barrier packages currently available for pharmaceutical products.
1.3 There are three methods: Method A is for bottles, Method B is for formed barrier blisters, and Method C is for formed quasi-barrier blisters. Methods B and C can be adapted for use with flexible pouches.
1.4 These test methods use gravimetric measurement to determine the rate of weight gain as a result of water vapor transmission into the package and subsequent uptake by a desiccant enclosed within the package. The packages are exposed to environments typical of those used for accelerated stability testing of drug products in the package (typically 40°C/75 % relative humidity [RH]).
1.5 For these methods, balance sensitivity, amount of desiccant, number of blisters per test unit, and weighing frequency were developed in an experiment based on Test Methods E96/E96M.
1.6 Test Methods E96/E96M gives specific instruction on the interactions among weighing frequency, number of data points necessary to establish steady state, minimum weight gain in a weighing period, and balance sensitivity.
1.7 The test methods in this standard were developed specifically for pharmaceutical bottles and blisters as closed container-closure systems. The experiment from which the methods were developed provided an inter-laboratory study from which the precision and bias statement was written. The packages in the study were small bottles and blisters used regularly for pharmaceutical solid oral dosage forms.
1.8 In spite of the specific nature of their application, the test methods in this standard should be suitable for other pharmaceutical packages and most types and sizes of other consumer packages.
1.9 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. The units of measure for bottles are milligrams per bottle per day (mg/bottle-day) and for blisters, milligrams per blister cavity per day (mg/cavity-day). These units may be used for both standard and referee testing.
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.
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Designation: D7709 − 12
Standard Test Methods for
Measuring Water Vapor Transmission Rate (WVTR) of
1
Pharmaceutical Bottles and Blisters
This standard is issued under the fixed designation D7709; 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 1.7 The test methods in this standard were developed
specifically for pharmaceutical bottles and blisters as closed
1.1 The three test methods described herein are for mea-
container-closure systems. The experiment from which the
surement of water vapor transmission rates (WVTRs) of
methods were developed provided an inter-laboratory study
high-barrier multiple-unit containers (bottles), high-barrier
from which the precision and bias statement was written. The
single-unit containers (blisters), and quasi-barrier single-unit
packages in the study were small bottles and blisters used
containers used for packaging pharmaceutical products. The
regularly for pharmaceutical solid oral dosage forms.
containersaretestedclosedandsealed.Thesetestmethodscan
be used for all consumer-sized primary containers and bulk 1.8 Inspiteofthespecificnatureoftheirapplication,thetest
primary containers of a size limited only by the dimensions of methods in this standard should be suitable for other pharma-
the equipment and the weighing capacity and sensitivity of the ceutical packages and most types and sizes of other consumer
balance. packages.
1.2 These test methods are intended to be of sufficient 1.9 The values stated in SI units are to be regarded as the
sensitivity and precision to allow clear discrimination among standard. No other units of measurement are included in this
the levels of barrier packages currently available for pharma- standard. The units of measure for bottles are milligrams per
ceutical products. bottle per day (mg/bottle-day) and for blisters, milligrams per
blistercavityperday(mg/cavity-day).Theseunitsmaybeused
1.3 There are three methods: Method A is for bottles,
for both standard and referee testing.
Method B is for formed barrier blisters, and Method C is for
1.10 This standard does not purport to address all of the
formed quasi-barrier blisters. Methods B and C can be adapted
safety concerns, if any, associated with its use. It is the
for use with flexible pouches.
responsibility of the user of this standard to establish appro-
1.4 These test methods use gravimetric measurement to
priate safety and health practices and determine the applica-
determine the rate of weight gain as a result of water vapor
bility of regulatory limitations prior to use.
transmission into the package and subsequent uptake by a
desiccant enclosed within the package. The packages are
2. Referenced Documents
exposed to environments typical of those used for accelerated
2
2.1 ASTM Standards:
stability testing of drug products in the package (typically
E96/E96MTest Methods for Water Vapor Transmission of
40°C/75 % relative humidity [RH]).
Materials
1.5 For these methods, balance sensitivity, amount of
desiccant, number of blisters per test unit, and weighing
3. Terminology
frequency were developed in an experiment based on Test
3.1 Definitions:
Methods E96/E96M.
3.1.1 barrier blister, n—blister made from high-barrier
1.6 Test Methods E96/E96M gives specific instruction on
material, formed and sealed so that the water vapor transmis-
the interactions among weighing frequency, number of data
sion rate (WVTR) (when tested at 40°C/75 % RH) is less than
points necessary to establish steady state, minimum weight
1.0 mg/cavity-day.
gain in a weighing period, and balance sensitivity.
3.1.2 blister, n—formed,liddedandsealedplasticdomethat
contains the solid oral product (usually one unit).
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible
Barrier Packaging and is the direct responsibility of Subcommittee F02.10 on
2
Permeation. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved May 1, 2012. Published June 2012. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ε1
approved in 2011. Last previous edition approved in 2011 as D7709–11 . DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/D7709-12. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
D7709 − 12
3.1.2.1 Discussion—Synonymous with cavity. 4.3 WVTR for Methods A or B is calculated using linear
regression of the weight versus time. The number of blisters
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation:D7709–11 Designation:D7709–12
Standard Test Methods for
Measuring Water Vapor Transmission Rate (WVTR) of
1
Pharmaceutical Bottles and Blisters
This standard is issued under the fixed designation D7709; 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
´ NOTE—Section X1.3 and Table X1.1 were corrected editorially in September 2011.
1. Scope
1.1 The three test methods described herein are for measurement of water vapor transmission rates (WVTRs) of high-barrier
multiple-unit containers (bottles), high-barrier single-unit containers (blisters), and quasi-barrier single-unit containers used for
packaging pharmaceutical products. The containers are tested closed and sealed. These test methods can be used for all
consumer-sized primary containers and bulk primary containers of a size limited only by the dimensions of the equipment and the
weighing capacity and sensitivity of the balance.
1.2 These test methods are intended to be of sufficient sensitivity and precision to allow clear discrimination among the levels
of barrier packages currently available for pharmaceutical products.
1.3 There are three methods: Method A is for bottles, Method B is for formed barrier blisters, and Method C is for formed
quasi-barrier blisters. Methods B and C can be adapted for use with flexible pouches.
1.4 Thesetestmethodsusegravimetricmeasurementtodeterminetherateofweightgainasaresultofwatervaportransmission
into the package and subsequent uptake by a desiccant enclosed within the package. The packages are exposed to environments
typicalofthoseusedforacceleratedstabilitytestingofdrugproductsinthepackage(typically40°C/75%relativehumidity[RH]).
1.5 For these methods, balance sensitivity, amount of desiccant, number of blisters per test unit, and weighing frequency were
developed in an experiment based on Test Methods E96/E96M.
1.6 Test Methods E96/E96M gives specific instruction on the interactions among weighing frequency, number of data points
necessary to establish steady state, minimum weight gain in a weighing period, and balance sensitivity.
1.7 The test methods in this standard were developed specifically for pharmaceutical bottles and blisters as closed
container-closuresystems.Theexperimentfromwhichthemethodsweredevelopedprovidedaninter-laboratorystudyfromwhich
the precision and bias statement was written. The packages in the study were small bottles and blisters used regularly for
pharmaceutical solid oral dosage forms.
1.8 In spite of the specific nature of their application, the test methods in this standard should be suitable for other
pharmaceutical packages and most types and sizes of other consumer packages.
1.9 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.
The units of measure for bottles are milligrams per bottle per day (mg/bottle-day) and for blisters, milligrams per blister cavity
per day (mg/cavity-day). These units may be used for both standard and referee testing.
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
2
2.1 ASTM Standards:
E96/E96M Test Methods for Water Vapor Transmission of Materials
3. Terminology
3.1 Definitions:
1
This test method is under the jurisdiction ofASTM Committee D10 on Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer, Pharmaceutical
and Medical Packaging.
Current edition approved April 1, 2011. Published April 2011. DOI: 10.1520/D7709-11.on Consumer, Pharmaceutical, Medical, and Child Resistant Packaging.
´1
Current edition approved May 1, 2012. Published June 2012. Originally approved in 2011. Last previous edition approved in 2011 as D 7709 – 11 . DOI:
10.1520/D7709-12.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
...
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