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ASTM E2500-07(2012)

(Guide)

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

SIGNIFICANCE AND USE
5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that manufacturing systems and equipment are fit for intended use, and to satisfy requirements for design, installation, operation, and performance.  
5.2 The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach.  
5.3 This guide supports, and is consistent with, the framework described in ICH Q8 and ICH Q9.  
5.4 This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.
SCOPE
1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety.  
1.2 For brevity, these are referred to throughout the rest of this guide as manufacturing systems.  
1.3 This guide may also be applied to laboratory, information, and medical device manufacturing systems.  
1.4 This guide is applicable to both new and existing manufacturing systems. The approach may be used for the implementation of changes to existing systems, and their continuous improvement during operation.  
1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.  
1.6 This standard does not address employee health and safety, environmental, or other non-GxP regulations. 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
14-Oct-2012
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.03 - General Pharmaceutical Standards
Current Stage
Ref Project

Relations

Replaces
ASTM E2500-07 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
Effective Date
15-Oct-2012
Referred By
ASTM E3051-16 - Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
Effective Date
15-Oct-2012
Referred By
ASTM E2898-20a - Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
Effective Date
15-Oct-2012
Referred By
ASTM E3106-22 - Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
Effective Date
15-Oct-2012
Referred By
ASTM E2629-20 - Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
Effective Date
15-Oct-2012
Referred By
ASTM E2363-23 - Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
Effective Date
15-Oct-2012
Referred By
ASTM E2656-16 - Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
Effective Date
15-Oct-2012
Referred By
ASTM E2476-22 - Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
Effective Date
15-Oct-2012
Referred By
ASTM E3077-17e2 - Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
Effective Date
15-Oct-2012

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ASTM E2500-07(2012) - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and EquipmentASTM E2500-07(2012) - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
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ASTM E2500-07(2012) - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
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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:E2500 −07(Reapproved 2012)
Standard Guide for
Specification, Design, and Verification of Pharmaceutical
and Biopharmaceutical Manufacturing Systems and
1
Equipment
This standard is issued under the fixed designation E2500; 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. Scope 2.2 Other Publications:
3
ICH Q8 Pharmaceutical Development Handbook
1.1 This guide is applicable to all elements of pharmaceu-
3
ICH Q9 Quality Risk Handbook
tical and biopharmaceutical manufacturing systems including:
Pharmaceutical cGMPs for the 21st Century —A Risk-
facility equipment, process equipment, supporting utilities,
4
Based Approach
associated process monitoring and control systems, and auto-
mation systems that have the potential to affect product quality
3. Terminology
and patient safety.
3.1 Definitions—For definitions of terms used in this guide,
1.2 For brevity, these are referred to throughout the rest of
refer to Terminology E2363.
this guide as manufacturing systems.
3.1.1 acceptance criteria—the criteria that a system or
1.3 This guide may also be applied to laboratory,
component must satisfy in order to be accepted by a user or
information, and medical device manufacturing systems.
other authorized entity.
1.4 This guide is applicable to both new and existing
3.1.2 design reviews—planned and systematic reviews of
manufacturing systems. The approach may be used for the
specifications, design, and design development and continuous
implementation of changes to existing systems, and their
improvement changes performed as appropriate throughout the
continuous improvement during operation.
life-cycle of the manufacturing system. Design reviews evalu-
ate deliverables against standards and requirements, identify
1.5 This guide is applicable throughout the life-cycle of the
problems, and propose required corrective actions.
manufacturing system from concept to retirement.
3.1.3 manufacturing systems—elements of pharmaceutical
1.6 This standard does not address employee health and
and biopharmaceutical manufacturing capability, including
safety, environmental, or other non-GxP regulations. This
manufacturingsystems,facilityequipment,processequipment,
standard does not purport to address all of the safety concerns,
supporting utilities, associated process monitoring and control
if any, associated with its use. It is the responsibility of the user
systems, and automation systems, that have the potential to
of this standard to establish appropriate safety and health
affect product quality and patient safety.
practices and determine the applicability of regulatory limita-
tions prior to use.
3.1.4 subject matter experts (SMEs)—individuals with spe-
cific expertise and responsibility in a particular area or field
2. Referenced Documents
(for example, quality unit, engineering, automation,
2
2.1 ASTM Standards:
development, operations, and so forth).
E2363 Terminology Relating to ProcessAnalytical Technol-
3.1.5 verification—a systematic approach to verify that
ogy in the Pharmaceutical Industry
manufacturing systems, acting singly or in combination, are fit
for intended use, have been properly installed, and are operat-
ing correctly. This is an umbrella term that encompasses all
1
types of approaches to assuring systems are fit for use such as
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture
of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.03
on General Pharmaceutical Standards.
Current edition approved Oct. 15, 2012. Published November 2012. Originally
3
approved in 2007. Last previous edition approved in 2007 as E2500 – 07. DOI: Available from International Conference on Harmonisation of Technical
10.1520/E2500-07R12. Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Switzerland, http://www.ich.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
the ASTM website. Rockville, MD 20857, http://www.fda.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2500−07 (2012)
qualification, commissioning and qualification, verification, 6.2.2 Two primary principles of quality risk management
syste
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ASTM E3336-22(Test Method)
Standard Test Method for Physical Integrity Testing of Single-Use Systems

SIGNIFICANCE AND USE
4.1 The test methods outlined in this standard allow for suppliers and end users of SUSs in (bio)pharmaceutical manufacturing processes to detect a leak and/or confirm the barrier properties of empty, clean, and dry SUSs. Performing integrity testing can be a significant contribution to the overall integrity assurance of SUSs.  
4.2 The two types of physical test methods outlined in this standard are:  
4.2.1 Section 5, Pressure-Based Test Methods.  
4.2.2 Section 6, Tracer Gas-Based Test Methods.
Note 3: Other test methods are currently being adapted for robust, reliable, and reproducible testing SUS, for example, Vacuum Decay Test Method as described in Test Method F2338.  
4.3 Pressure-based test methods are generally less sensitive compared to tracer gas-based test methods but have a lower complexity and cost. To assist in selecting a method that will fit an application, refer to Table 1 in Practice E3244 for a more detailed comparison of the two methods.  
4.4 Both types of test methods can be used to detect leaks of any sizes in a SUS (referred to as leak testing) or confirm the barrier properties of the SUS (referred to as integrity testing).  
4.5 To ensure that integrity testing performed on SUSs is effective and accurate, the properties of the SUS (pressure capabilities, volume, material properties, etc.) must be considered. Also, a validation should be performed on the chosen test method as further described in 5.11 and 6.11.  
4.6 Practice E3244 should be referenced to determine the maximum allowable leakage limit for a SUS, along with the routine testing requirements that are suitable for each application.  
4.7 The purpose of the described test methods is not to stress the SUS until a potential defect occurs. The testing parameters, mainly test pressure, are independent from the use-case conditions. The robustness of the SUS under use-case conditions should be proven during product qualification.  
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1.1 The test methods described in this standard are applicable for single-use manufacturing equipment, further called Single-use Systems (SUSs), used for (bio)pharmaceutical products.  
1.2 The test methods described in this standard are not intended to be used on single-use technology for primary containers, combination products (products composed of any combination of a drug, device, or biological product), or devices. Appropriate procedures related to these products are discussed in documents covering the integrity assurance for primary containers (1)2 or medical products (2-4).  
1.3 The test methods and their validation are described to only cover testing of empty and dry SUSs. Residual liquid in the SUS can impact the test reliability and reproducibility.  
1.4 The test methods are intended to be used to confirm the barrier properties of the test article, further called integrity testing, or test the SUS for leaks of certain sizes, further called leak testing.
Note 1: To verify that an integrity test can confirm the intended barrier properties of the SUS, its detection limit must be equal or better than the respective maximum allowable leakage limit.  
1.5 The physical test methods covered by this standard are:  
1.5.1 Pressure-based test methods.  
1.5.2 Tracer gas-based test methods.  
1.6 The physical test methods described are in general non-destructive and allow further use of the SUS.
Note 2: Some variations can be used in a destructive way, for example, to perform root cause analysis of the leak.  
1.7 The standard describes the test apparatuses, operation procedures, environment requirements, and discusses specific challenges with testing SUSs, as well as how to perform robust validation of the test method.  
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ASTM E3250-21(Practice)
Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying

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3.1 This practice deals with recommended best practices for freeze dryer instrumentation, particularly which is used for monitoring the status of the product during freeze drying and perhaps for equipment capability testing. Temperature and pressure are both critical variables affecting heat transfer, mass transfer, process efficiency, and product quality. For this reason, particular emphasis is placed on product temperature and pressure measurement within the freeze dryer. The methods discussed in this guide are limited to techniques that are equally applicable at both laboratory and production scale.  
3.2 Finally, it is recognized that “best practice” changes over time as new technology matures and process understanding deepens.
SCOPE
1.1 Recommended best practices in monitoring of product status during pharmaceutical freeze drying are presented focusing on methods that apply to both laboratory and production scale.  
1.2 With respect to product temperature measurement, sources of uncertainty associated with any type of measurement probe are discussed, as well as important differences between the two most common types of temperature-measuring instruments ― thermocouples and resistance temperature detectors (RTD). Two types of pressure transducers are discussed ― thermal conductivity type gauges and capacitance manometers, with the Pirani gauge being the thermal conductivity type gauge of choice. It is recommended that both types of pressure gauge be used on both the product chamber and the condenser for freeze dryers with an external condenser, and the reasoning for this recommendation is discussed.  
1.3 Aseptic filling and sterilization practices are outside the scope of this practice. These are recommendations to assist users in selecting best practices and they are not intended to supersede or replace regulatory requirements.  
1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard with the exception of mTorr for pressure measurement  
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ASTM E2500-20(Guide)
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

SIGNIFICANCE AND USE
5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that manufacturing systems and equipment are fit for intended use, for example, qualified, and to satisfy requirements for design, installation, operation, and performance.  
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Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

SIGNIFICANCE AND USE
4.1 This guide supports the principles of Guide E2500 and extends these principles to validation of analytical methods for PAT applications. The ongoing process of method validation is graphically represented in Fig. 1, which shows the life cycle of the validation of analytical methods for PAT applications. Prerequisites for validation are the identification of the measurement requirements and development of a method to meet those requirements.  
FIG. 1 Life Cycle for the Validation of Analytical Method for PAT Applications  
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2.1 This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure reproducibility of results.  
2.2 Once a unit meets all of the mechanical specifications included in this practice, it is considered calibrated and further calibration with dissolution calibrator tablets is not required.
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ASTM E3230-20(Practice)
Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing

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4.1 Conventional stainless-steel process equipment for biopharmaceutical manufacturing require cleaning and sterilization prior to implementation. Single-use systems (SUS), stand-alone equipment typically composed of plastic components and assemblies, are usually assembled in cleanrooms and are usually not cleaned or rinsed prior to implementation (with the exception of filters, which are often rinsed prior to use). SUS cleanliness with respect to particulate matter depends upon the quality of the SUS manufacturing process, and also upon the care and handling of the SUS upon implementation by the end-user.  
4.2 In the process of manufacturing single-use components or assemblies, particulate matter may adhere to the interior (fluid contacting) or exterior surfaces of SUS (BPSA). Visual inspection of SUS components and assemblies for particulate matter is often limited by translucent or opaque materials which inhibit visualization, especially of interior fluid-contacting surfaces. Also in some cases, the large size of single-use assemblies significantly reduces the effectiveness of visual inspections. A more complete assessment of particulate matter load requires a method to extract particulate matter from the surfaces of single-use components or assemblies using a test liquid, which makes the particles readily available for analytical characterization using counting, sizing and chemical/physical identification methods.  
4.3 Pharmaceutical manufacturers use a wide variety of configurations and sizes of single-use components and assemblies, such as bioreactors, bioprocess containers, tubing, connectors, clamps, valves, sensors and filters. Extraction of particulate matter may be relatively easy from small components with readily accessible surfaces, however, extraction of particulate matter from large and complex assemblies with less readily accessible interior surfaces may require significantly more effort.  
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SCOPE
1.1 This practice describes the requirements for development, qualification, and routine application of a procedure for the effective liquid extraction of particulate matter from the surfaces of single-use components and assemblies designed for use in biopharmaceutical manufacturing processes. The extraction generates a suspension of particulate matter in liquid which makes the particulate matter readily available for analytical characterization.  
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1.3 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.  
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SIGNIFICANCE AND USE
5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that SUS are fit for their intended use and to satisfy requirements for sourcing, supply, design, specification, installation, operation, and performance.  
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5.4 This guide may be used independently or in conjunction with other ASTM Committee E55 proposed standards to be published by ASTM International.  
5.5 Specific standard practices about extractables, leachables, particulate matter, and integrity testing/leak detection, biocompatibility, and raw materials as available should be used by suppliers and end users and applied to their own manufacturing process facilities.
SCOPE
1.1 This guide is intended as a complement to Guide E2500.  
1.2 This guide is applicable to the range of manufacturing systems described in Guide E2500, specifically all elements of single-use systems, or hybrids of single-use and traditional components, used for the manufacturing of pharmaceutical and biopharmaceutical products, including: materials of construction, components, assembly, manifolds, supporting utilities, associated process monitoring and control systems, automation systems, and controlled environment that have the potential to affect product quality and patient safety.  
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1.4 For brevity, single-use systems are referred to as SUS throughout the rest of this guide.  
1.5 The approach may be applied by the end user, the supplier of SUS, and raw materials sub-suppliers further back in the supply chain.  
1.6 This guide is not intended to apply to the use of single-use technology for packaging, primary containers, combination products (products composed of any combination of a drug, device, or biological product) or devices.  
1.7 This guide does not address specific local requirements, which remain the responsibility of the end user.  
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ASTM D8270-23b(Terminology)
Standard Terminology Relating to Cannabis

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1.1 This terminology is a compilation of definitions of technical terms used in the cannabis industry. Terms that are generally understood or adequately defined in other readily available sources are not included.  
1.2 When a term is used in an ASTM document for which Committee D37 is responsible it is included only when judged, after review by Subcommittee D37.91, to be a generally usable term.  
1.3 Definitions that are identical to those published by other ASTM committees or other standards organizations are identified with the committee number (for example, D20) or with the abbreviation of the name of the organization (for example, IUPAC, International Union of Pure and Applied Chemistry).  
1.4 A definition is a single sentence with additional information included in discussions.  
1.5 Definitions are followed by the committee responsible for the standard(s) (for example, [D37.01]) and standard designation(s) in which they are used (for example, D8219).  
1.6 Abbreviated Terminology:  
1.6.1 Abbreviated terminology is intended to provide uniform contractions of terms relating to cannabis that have evolved through widespread common usage. The compilation in this standard has been prepared to avoid the occurrence of more than one abbreviated term for a given cannabis term and to avoid multiple meanings for abbreviated terms.  
1.6.2 The abbreviated terminology and descriptions in this standard are intended to be consistent with usage in the cannabis industry and the standards under D37 jurisdiction. Other ASTM committees may assign a different word-phrase description to the same abbreviated terminology. In such cases, the abbreviated terms in this standard shall apply to usage in D37 standards, or if widespread misunderstanding could result from conflicting abbreviated terminology descriptions, the abbreviated terminology for the word-phrase shall not be used in D37 standards.  
1.6.3 Acronyms and Initialisms—A word formed from the letters or parts of words of a longer word-phrase, usually from the initial letters or parts of the words. An acronym is pronounced as a word (for example, radar for radio detection and ranging). An initialism is pronounced as a series of letters (for example, DOT for Department of Transportation).  
1.6.4 The acronym or initialism description is the origin word-phrase for the acronym or initialism, not a definition.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 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.

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ASTM D7709-12(2023)(Test Method)
Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

SIGNIFICANCE AND USE
5.1 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.  
5.2 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.11 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 Ba...

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ASTM
ASTM D8499-23(Guide)
Standard Guide for Meeting the Specifications of ASTM D8432

SIGNIFICANCE AND USE
4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers’ sojourn are in order.  
4.2 This standard is intended to assure safety, quality, and weight stabilization of packaged cannabis/hemp flower during transit operations.  
4.3 This standard is intended to be used by purveyors who move the packaged cured flower between licensed operators or to the end user.  
4.4 This standard is intended to be used by samplers and testing laboratories transporting samples to a laboratory to assure that samples analyzed represent as accurately as possible, the material that was gathered to provide the sample for analysis.
SCOPE
1.1 Specification D8432 covers the environmental conditions, such as temperature, humidity, and lighting under which the cured, dry, cannabis/hemp flowers packaged in fresh format and intended for human use can be maintained in transit to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the purveyor of transportation of cannabis/hemp can meet those specifications.  
1.1.1 This standard does not apply to frozen cannabis/hemp.  
1.1.2 This standard does not apply to cannabis/hemp intended for extraction.  
1.2 This standard applies to controlling the environment surrounding packaged cannabis/hemp flower in transit, either within the package itself or in the environment surrounding the package, or both.  
1.3 This standard is to be followed by licensed operators in the cannabis/hemp space who move the packaged crop(s) through the distribution supply chain to another licensed operator or to the end user.  
1.4 Purveyors of cannabis/hemp flower include, but are not necessarily limited to: the packager, transportation companies, warehousing operations, and retail operations.  
1.5 Security of the packaged cannabis/hemp flower while in transit is not within the scope of this standard.  
1.6 This standard is intended to remain valid until ownership of the packaged cannabis/hemp flower is transferred to another licensed operator or to the final consumer.  
1.7 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 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.

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