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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

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.  
1.4 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
29-Feb-2020
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

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ASTM E3230-20 - Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical ManufacturingASTM E3230-20 - 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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ASTM E3230-20 - 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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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: E3230 − 20
Standard Practice for
Extraction of Particulate Matter from the Surfaces of Single-
Use Components and Assemblies Designed for Use in
1
Biopharmaceutical Manufacturing
This standard is issued under the fixed designation E3230; 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.
3
1. Scope 2.2 USP Documents:
USP <788> Particulate Matter in Injections, 2012
1.1 This practice describes the requirements for
USP <790> Visible Particulates in Injections, 2017
development, qualification, and routine application of a proce-
USP <1788> Methods for the Determination of Particulate
dure for the effective liquid extraction of particulate matter
Matter in Injections and Ophthalmic Solutions, 2012
from the surfaces of single-use components and assemblies
USP <1790> Visual Inspection of Injections, 2018
designed for use in biopharmaceutical manufacturing pro-
4
2.3 ISO Documents:
cesses. The extraction generates a suspension of particulate
ISO 16232:2018 Road Vehicles – Cleanliness of Compo-
matter in liquid which makes the particulate matter readily
nents and Systems
available for analytical characterization.
2.4 Other Documents:
BPSA Recommendations for Testing, Evaluation, and Con-
1.2 The values stated in SI units are to be regarded as
trol of Particulates from Single-Use Process Equipment,
standard. No other units of measurement are included in this
5
2014
standard.
6
JP 6.07 Insoluble Particulate Matter Test for Injections
1.3 This standard does not purport to address all of the
Ph. Eur. 2.9.19 Particulate Contamination: Sub-Visible Par-
safety concerns, if any, associated with its use. It is the 7
ticles
responsibility of the user of this standard to establish appro-
VDA 19 Part 1 Inspection of Technical Cleanliness, March
8
priate safety, health, and environmental practices and deter-
2012
mine the applicability of regulatory limitations prior to use.
3. Terminology
1.4 This international standard was developed in accor-
dance with internationally recognized principles on standard-
3.1 Definitions:
ization established in the Decision on Principles for the
3.1.1 agitation, n—an extraction method by which a test
Development of International Standards, Guides and Recom- article partially filled with test liquid is moved to create liquid
mendations issued by the World Trade Organization Technical motion relative to the internal surfaces of the test article.
Barriers to Trade (TBT) Committee.
3.1.2 bioprocess container, n—a container (bag, bottle, tank,
etc.) used primarily for liquid, frozen liquid, or powder storage
2. Referenced Documents
during various stages of biopharmaceutical manufacturing
2
processing.
2.1 ASTM Standards:
E3060 Guide for Subvisible Particle Measurement in Bio- 3.1.3 background particle count, n—average or range, or
pharmaceutical Manufacturing Using Dynamic (Flow) both, of particle counts obtained upon executing the extraction
Imaging Microscopy procedure without the test article present.
3
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook
1
This practice is under the jurisdiction of ASTM Committee E55 on Manufac- Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
4
ture of Pharmaceutical and Biopharmaceutical Products and is the direct responsi- Available from International Organization for Standardization (ISO), ISO
bility of Subcommittee E55.07 on Single Use Systems. Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
Current edition approved March 1, 2020. Published May 2020. DOI: 10.1520/ Geneva, Switzerland, http://www.iso.org.
5
E3230-20. Available from BioProcess Systems Alliance, 1400 Crystal Drive, Suite 630
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Arlington, VA 22202, https://bpsalliance.org.
6
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from Japanese Pharmacopoeia.
7
Standards volume information, refer to the standard’s Document Summary page on Available from European Pharmacopoeia.
8
the ASTM website. Available from Verband der Automobilindustrie, https://www.vda.de/en.html.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E3230 − 20
3.1.4 background test, n—application of the same extraction 3.1.22 particle count total (PTn), n—total particle count
conditions
...

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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.  
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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).  
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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:  
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1.5.2 Tracer gas-based test methods.  
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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.  
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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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SCOPE
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1.5 This guide is intended to remain valid until the packaged cannabis/hemp flower is placed in storage or transit.  
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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 storage.  
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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.  
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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
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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.  
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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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