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ASTM E3250-21

(Practice)

Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying

Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying

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.  
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.  
1.6 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-Apr-2021
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.05 - Lyophilization
Current Stage
Ref Project

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ASTM E3250-21 - Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze DryingASTM E3250-21 - Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying
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ASTM E3250-21 - Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying
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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: E3250 − 21
Standard Practice for
Product Temperature and Equipment Pressure
1
Instrumentation in Pharmaceutical Freeze Drying
This standard is issued under the fixed designation E3250; 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 Recommended best practices in monitoring of product 2.1 ASTM Standards:
status during pharmaceutical freeze drying are presented fo- E230 Specification for Temperature-Electromotive Force
cusingonmethodsthatapplytobothlaboratoryandproduction (emf) Tables for Standardized Thermocouples
3
scale. 2.2 ICH Standard:
ICH Q8(R2) Pharmaceutical Development
1.2 With respect to product temperature measurement,
sources of uncertainty associated with any type of measure-
3. Significance and Use
ment probe are discussed, as well as important differences
3.1 This practice deals with recommended best practices for
between the two most common types of temperature-
freeze dryer instrumentation, particularly which is used for
measuring instruments — thermocouples and resistance tem-
monitoring the status of the product during freeze drying and
perature detectors (RTD). Two types of pressure transducers
perhaps for equipment capability testing. Temperature and
are discussed — thermal conductivity type gauges and capaci-
pressure are both critical variables affecting heat transfer, mass
tance manometers, with the Pirani gauge being the thermal
transfer, process efficiency, and product quality. For this
conductivity type gauge of choice. It is recommended that both
reason, particular emphasis is placed on product temperature
types of pressure gauge be used on both the product chamber
and pressure measurement within the freeze dryer. The meth-
and the condenser for freeze dryers with an external condenser,
ods discussed in this guide are limited to techniques that are
and the reasoning for this recommendation is discussed.
equally applicable at both laboratory and production scale.
1.3 Aseptic filling and sterilization practices are outside the
3.2 Finally, it is recognized that “best practice” changes
scope of this practice. These are recommendations to assist
over time as new technology matures and process understand-
users in selecting best practices and they are not intended to
ing deepens.
supersede or replace regulatory requirements.
1.4 Units—The values stated in SI units are to be regarded
4. Product Temperature Measurement
as the standard. No other units of measurement are included in
4.1 When developing a freeze-dry cycle for any product, it
this standard with the exception of mTorr for pressure mea-
is essential to collect reliable data on product temperature
surement
throughout the freeze-dry process. It shall be ascertained that
1.5 This standard does not purport to address all of the
the product is frozen to a suitably low temperature and held at
safety concerns, if any, associated with its use. It is the
that temperature for a sufficient time to ensure complete
responsibility of the user of this standard to establish appro-
product freezing and equilibration with the frozen temperature.
priate safety, health, and environmental practices and deter-
Identifying appropriate conditions for primary drying, which is
mine the applicability of regulatory limitations prior to use.
usually the longest part of a freeze-dry cycle, requires knowl-
1.6 This international standard was developed in accor-
edge of the equipment limit and the upper product temperature
dance with internationally recognized principles on standard-
limit for primary drying be established based on materials
ization established in the Decision on Principles for the
characterization backed by stability studies, and that the
Development of International Standards, Guides and Recom-
product temperature during primary drying remain a safe
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
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
1
This practice is under the jurisdiction of ASTM Committee E55 on Manufac- Standards volume information, refer to the standard’s Document Summary page on
ture of Pharmaceutical and Biopharmaceutical Products and is the direct responsi- the ASTM website.
3
bility of Subcommittee E55.05 on Lyophilization. Available from International Council for
...

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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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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.  
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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.
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SCOPE
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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.  
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SCOPE
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SIGNIFICANCE AND USE
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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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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.  
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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.  
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1.6 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this guide.  
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Standard Guide for Meeting the Specifications of ASTM D8423

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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
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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.  
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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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