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ASTM E2500-20

(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, for example, qualified, 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, ICH Q9, ICH Q10, and ICH Q11.  
5.4 This guide is designed to conform with FDA, EU, and other international regulations regarding equipment and facility suitability for use and qualification.  
5.5 This guide may be used independently or in conjunction with other Committee E55 standards published by ASTM International.
SCOPE
1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: good manufacturing practice (GMP) utility 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 implementation of changes to existing systems.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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
30-Sep-2020
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.11 - Process Design
Current Stage
Ref Project

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ASTM E2500-20 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and EquipmentASTM E2500-20 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
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REDLINE ASTM E2500-20 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and EquipmentREDLINE ASTM E2500-20 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
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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: E2500 − 20
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. Referenced Documents
2
2.1 ASTM Standards:
1.1 This guide is applicable to all elements of pharmaceu-
E2363 Terminology Relating to Manufacturing of Pharma-
tical and biopharmaceutical manufacturing systems including:
ceutical and Biopharmaceutical Products in the Pharma-
good manufacturing practice (GMP) utility equipment, process
ceutical and Biopharmaceutical Industry
equipment, supporting utilities, associated process monitoring
E2474 Practice for Pharmaceutical Process Design Utilizing
and control systems, and automation systems that have the
3
Process Analytical Technology (Withdrawn 2020)
potential to affect product quality and patient safety.
E2476 Guide for Risk Assessment and Risk Control as it
1.2 For brevity, these are referred to throughout the rest of
Impacts the Design, Development, and Operation of PAT
this guide as manufacturing systems.
Processes for Pharmaceutical Manufacture
E2537 Guide for Application of Continuous Process Verifi-
1.3 This guide may also be applied to laboratory,
cation to Pharmaceutical and Biopharmaceutical Manu-
information, and medical device manufacturing systems.
facturing
1.4 This guide is applicable to both new and existing
E2629 Guide for Verification of Process Analytical Technol-
manufacturing systems. The approach may be used for imple-
ogy (PAT) Enabled Control Systems
mentation of changes to existing systems.
E3051 Guide for Specification, Design, Verification, and
1.5 This guide is applicable throughout the life-cycle of the Application of Single-Use Systems in Pharmaceutical and
Biopharmaceutical Manufacturing
manufacturing system from concept to retirement.
2.2 Other Publications:
1.6 This standard does not address employee health and
4
EU GMP Annex 15 Qualification and Validation
safety, environmental, or other non-GxP regulations. This
FDA Guidance for Industry Process Validation: General
standard does not purport to address all of the safety concerns,
4
Principles and Practices
if any, associated with its use. It is the responsibility of the user
5
ICH Q8 Pharmaceutical Development
of this standard to establish appropriate safety, health, and
5
ICH Q9 Quality Risk Management
environmental practices and determine the applicability of
5
ICH Q10 Pharmaceutical Quality System
regulatory limitations prior to use.
ICH Q11 Development and Manufacture of Drug Substances
1.7 This international standard was developed in accor-
(Chemical Entities and Biotechnological/Biological Enti-
dance with internationally recognized principles on standard- 5
ties)
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
mendations issued by the World Trade Organization Technical
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Barriers to Trade (TBT) Committee.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
The last approved version of this historical standard is referenced on
www.astm.org.
1 4
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of Rockville, MD 20857, http://www.fda.gov.
5
Subcommittee E55.11 on Process Design. Available from International Conference on Harmonisation of Technical
Current edition approved Oct. 1, 2020. Published November 2020. Originally Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
approved in 2007. Last previous edition approved in 2013 as E2500 – 13. DOI: Secretariat, 9, chemin des Mines, P.O. Box 195, 1211 Geneva 20, Switzerland,
10.1520/E2500-20. http://www.ich.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2500 − 20
Pharmaceutical cGMPs for the 21st Century — A Risk- quality, and consequently to patient safety, are effectively
4
Based Approach managed to the extent t
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
Designation: E2500 − 13 E2500 − 20
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
1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility
good manufacturing practice (GMP) utility 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. systems.
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 safety, health, and healthenvironmental practices and determine the applicability of
regulatory limitations prior to use.
1.7 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
3
E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
E2475 Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of
Subcommittee E55.03 on General Pharmaceutical Standards.
Current edition approved Nov. 1, 2013Oct. 1, 2020. Published November 2013November 2020. Originally approved in 2007. Last previous edition approved in 20122013
as E2500 – 07 (2012). 13. DOI: 10.1520/E2500-13.10.1520/E2500-20.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’sstandard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2500 − 20
E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes
for Pharmaceutical Manufacture
E2537 Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
E2629 Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
E3051 Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biophar-
maceutical Manufacturing
2.2 Other Publications:
4
EU GMP Annex 15 Qualification and Validation
4
FDA Guidance for Industry Process Validation: General Principles and Practices
5
ICH Q8 Pharmaceutical Development
5
ICH Q9 Quality Risk Management
5
ICH Q10 Pharmaceutical Quality System
5
ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
4
Pharmaceutical cGMPs for the 21st Century —A — A Risk-Based Approach
3. Terminology
3.1 Definitions—For definitions of terms used in this guide, refer to Terminology E2363.
3.1.1 acceptance c
...

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ASTM E3336-22(Test Method)
Standard Test Method for Physical Integrity Testing of Single-Use Systems

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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:  
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SCOPE
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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SIGNIFICANCE AND USE
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.  
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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.  
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ASTM E2898-20a(Guide)
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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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SCOPE
1.1 This guide provides an overview to the risk-based validation of process analytical methods under a process analytical technology (PAT) paradigm for pharmaceuticals and biopharmaceuticals and as such includes guidance on assessing risk to product quality from inappropriate method validation.  
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SIGNIFICANCE AND USE
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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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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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Standard Guide for Meeting the Specifications of ASTM D8423

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4.2 This standard is intended to assure safety, quality, and weight stabilization of packaged cannabis/hemp flower during storage.  
4.3 This standard is intended to be used by purveyors who store the packaged cured flower between packaging and subsequent transfer to other licensed operators or to the end user.  
4.4 This standard is intended to be used by samplers and testing laboratories storing samples prior to laboratory analyses 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 D8423 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 storage to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the purveyor of storage 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 The standard applies to controlling the environment surrounding packaged cannabis/hemp flower during storage, 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 storage 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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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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ASTM
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 D8498-23(Guide)
Standard Guide for Compliance to the Specifications of ASTM D8450

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 guide is intended to assist in assuring safety, quality, and weight stabilization of cannabis/hemp flower during indoor packaging operations.  
4.3 This guide is intended to assist in assuring that packaged cannabis/hemp flower has a water activity of 0.55 to 0.65 per Specification D8197.  
4.4 This guide is intended to be used by purveyors who move the cured crop to consumer or non-consumer packaging used for distribution.
SCOPE
1.1 Specification D8450 specifies the environmental conditions, such as temperature, humidity, and lighting under which the cured, dry, cannabis/hemp flowers in fresh format intended for human use are to be packaged to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the packager of cannabis/hemp can meet Specification D8450.  
1.1.1 This guide does not apply to frozen cannabis/hemp.  
1.1.2 This guide does not apply to cannabis/hemp intended for extraction.  
1.2 This guide applies only to controlling an indoor environment (heat, cooling, humidity control, lighting) surrounding packaging operations. Outdoor operations are outside the scope of this guide and are not addressed.  
1.3 This guide can be used by licensed operators in the cannabis/hemp space who move the cured crop(s) into consumer or non-consumer packaging used for distribution.  
1.4 Security of the cannabis/hemp flower during the packaging process is not within the scope of this guide.  
1.5 This guide is intended to remain valid until the packaged cannabis/hemp flower is placed in storage or transit.  
1.6 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this guide.  
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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    3 pages
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