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ASTM E3051-16

(Guide)

Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing

Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing

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.  
5.2 The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMP’s for the 21st Century – A Risk-Based Approach. It supports and is consistent with the framework described in FDA Guidance for Industry, Process Validation: General Principles and Practices, in ICH Q7, ICH Q8 (R2), ICH Q9, and ICH Q10.  
5.3 This guide includes concepts developed in the PDA Technical Report No. 66.  
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.  
1.3 This guide is applicable for the implementation of changes to manufacturing system design for existing systems. It may be used for continuous improvement and changes in operation from clinical through to commercial scale.  
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.  
1.8 This guide does not address employee health and safety, environmental, nor other good engineering and manufacturing practices (GXP) requirements. 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
Published
Publication Date
31-Jan-2016
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.07 - Single Use Systems
Current Stage
Ref Project

Relations

Refers
ASTM D4169-14 - Standard Practice for Performance Testing of Shipping Containers and Systems
Effective Date
01-Nov-2014

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ASTM E3051-16 - Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical ManufacturingASTM E3051-16 - Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
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ASTM E3051-16 - Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
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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: E3051 − 16
Standard Guide for
Specification, Design, Verification, and Application of
Single-Use Systems in Pharmaceutical and
1
Biopharmaceutical Manufacturing
This standard is issued under the fixed designation E3051; 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
1.1 This guide is intended as a complement to Guide E2500.
2.1 ASTM Standards:
D4169 Practice for Performance Testing of Shipping Con-
1.2 This guide is applicable to the range of manufacturing
tainers and Systems
systems described in Guide E2500, specifically all elements of
E2363 Terminology Relating to Manufacturing of Pharma-
single-use systems, or hybrids of single-use and traditional
components, used for the manufacturing of pharmaceutical and ceutical and Biopharmaceutical Products in the Pharma-
biopharmaceutical products, including: materials of ceutical and Biopharmaceutical Industry
construction, components, assembly, manifolds, supporting
E2500 Guide for Specification, Design, and Verification of
utilities, associated process monitoring and control systems,
Pharmaceutical and Biopharmaceutical Manufacturing
automation systems, and controlled environment that have the
Systems and Equipment
potential to affect product quality and patient safety.
3
2.2 United States Pharmacopeia:
1.3 This guide is applicable for the implementation of
USP<788> Particulate Matter in Injections
changes to manufacturing system design for existing systems.
USP<790> Visible Particulates in Injections
It may be used for continuous improvement and changes in
2.3 International Conference on Harmonization of Techni-
operation from clinical through to commercial scale.
cal Requirements for Registration of Pharmaceuticals for
1.4 For brevity, single-use systems are referred to as SUS 4
Human Use (ICH):
throughout the rest of this guide.
ICH Q7 Good Manufacturing Practice Guide for Active
1.5 The approach may be applied by the end user, the
Pharmaceutical Ingredients
supplier of SUS, and raw materials sub-suppliers further back
ICH Q8 (R2) Pharmaceutical Development
in the supply chain.
ICH Q9 Quality Risk Management
ICH Q10 Pharmaceutical Quality System
1.6 This guide is not intended to apply to the use of
5
single-use technology for packaging, primary containers, com-
2.4 ISO Standards:
bination products (products composed of any combination of a
ISO 13485:2003 Medical Devices—Quality Management
drug, device, or biological product) or devices.
Systems—Requirements for Regulatory Purposes
1.7 This guide does not address specific local requirements,
ISO 14644 Cleanrooms and Associated Controlled Environ-
which remain the responsibility of the end user.
ments
ISTA 3A General Simulation Performance tests
1.8 This guide does not address employee health and safety,
environmental, nor other good engineering and manufacturing
practices (GXP) requirements. This standard does not purport
to address all of the safety concerns, if any, associated with its 2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
use. It is the responsibility of the user of this standard to contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
establish appropriate safety and health practices and deter-
the ASTM website.
mine the applicability of regulatory limitations prior to use.
3
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook
Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
4
Available from International Conference on Harmonisation of Technical
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of Secretariat, 9, chemin des Mines, P.O. Box 195, 1211 Geneva 20, Switzerland,
Subcommittee E55.07 on Single Use Systems. http://www.ich.org.
5
Current edition approved Feb. 1, 2016. Published March 2016. DOI: 10.1520/ Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
E3051-16. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E3051 − 16
6
2.5 U.S. Food and Drug Administratio
...

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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.  
4.8 This standard test method describes the...
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.  
1.8 This standard does not include methods to determine the maximum allowable leakage limit for maintaining the barrier properties of the SUS. For that, refer to Practice E3244 and Test Me...

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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  
1.5 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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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.  
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SCOPE
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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.  
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1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.  
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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  
4.2 The method risk assessment also takes into account the stage in the product life cycle at which the measurements are being made and how the resulting data will be used. The integration of these considerations in the risk assessment facilitates the determination of the level of validation necessary to ensure that the method is fit for purpose.  
4.3 Changes may occur during the product life cycle necessitating identification of changes to the measurement requirements and method update and revalidation. Procedures should be established to evaluate the continued suitability of the process analytical method and to make appropriate recommendations to update the process analytical method for the intended use during the product life cycle.  
4.4 Additional informative examples can be found in Practices D3764, D6122, E1655, E1790, E2056, E2617, and E2656; and Guide E2891 that address validation of methods and models. Other useful standards include ASME BPE2019, ISO 14971, ISO 15839, and USP Acoustic Emission .
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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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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1.1 This practice covers the set-up and calibration of the paddle and basket dissolution apparatus.  
1.2 Use of this practice may be applied to apparatus that have been modified to enable automatic dissolution testing (that is, a valve in the bottom of the vessel or sampling through the shaft).  
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.  
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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

SIGNIFICANCE AND USE
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.  
4.4 The wide variety of single-use components and asse...
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.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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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Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

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4.1 The methodology was originally developed (1-4)6 for use in drug content uniformity and dissolution but has general application to any multistage test with multiple acceptance criteria. Practice E2709 summarizes the statistical aspects of this methodology. This practice applies the general methodology of Practice E2709 specifically to the UDU test.  
4.1.1 While other methods can be used to estimate the probability of passing the UDU test, they are outside the scope of this practice.  
4.2 The UDU test procedure describes a two-stage sampling test, where at each stage one can pass or continue testing, and the decision to fail is deferred until the second stage. At each stage there are acceptance criteria on the test results as outlined in Table 1.    
4.3 The UDU test is a market standard. The USP General Notices include the following statement about compendial standards. “The similarity to statistical procedures may seem to suggest an intent to make inference to some larger group of units, but in all cases, statements about whether the compendial standard is met apply only to the units tested.” Therefore, the UDU procedure is not intended for inspecting uniformity of finished product for lot/batch release or as a lot inspection procedure.  
4.3.1 The UDU test defines a product requirement to be met at release and throughout the shelf-life of the product.  
4.3.2 Passing the UDU test once does not provide statistical assurance that a batch of drug product meets specified statistical quality control criteria.  
4.4 This practice provides a practical specification that may be applied when uniformity of dosage units is required. An acceptance region for the mean and standard deviation of a set of test results from the lot is defined such that, at a prescribed confidence level, the probability that a future sample from the lot will pass the UDU test is greater than or equal to a prespecified lower probability bound. Having test results fall in the acceptance r...
SCOPE
1.1 This practice provides a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU) test. This test is given in General Chapter  Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity of Dosage Units of the Ph. Eur., and in 6.02 Uniformity of Dosage Units of the JP, and these versions are virtually interchangeable. For this multiple-stage test, the procedure computes a lower bound on the probability of passing the UDU test, based on statistical estimates made at a prescribed confidence level from a sample of dosage units.  
1.2 This methodology can be used to generate an acceptance limit table, which defines a set of sample means and standard deviations that assures passing the UDU test for a prescribed lower probability bound, confidence level, and sample size.  
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Standard Terminology Relating to Cannabis

SCOPE
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:  
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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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