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ASTM E3177-18

(Guide)

Standard Guide on Sampling for Process Analytical Technology

Standard Guide on Sampling for Process Analytical Technology

SIGNIFICANCE AND USE
4.1 Application of this guidance should enable PAT method developers to design and implement reliable PAT applications that avoid many common sources of error around sampling. Sampling is a key element of method and process validation plans.  
4.1.1 Many ASTM standards discuss sampling; however, almost all are very specific to a certain field or application. For example, the “Standard Practice for Automatic Sampling of Petroleum and Petroleum Products” (D4177) specifically covers information for the design, installation, testing, and operation of automated equipment for the extraction of representative samples of petroleum and petroleum products from a flowing stream and storing them in a sample receiver.  
4.1.2 Other useful ASTM standards include: E105 (Practice for Probability Sampling of Materials), E122 (Standard Practice for Calculating Sample Size to Estimate, With a Specified Precision, the Average for a Characteristic of a Lot or Process), E1402 (Standard Guide for Sampling Design), and E456 (Terminology Relating to Quality and Statistics). These standards review similar considerations as those addressed in this guidance and can be consulted for additional insight on how to deal with specific sample types or situations. However, such standards should be carefully reviewed for relevance to pharmaceutical applications.
SCOPE
1.1 This document is to be used as a guide to Process Analytical Technology (PAT) instrument sampling, and covers both the sample from which PAT data is collected and the sample that is taken for reference assay. The ASTM definition of a guide is a compendium of information or series of options that does not recommend a specific course of action. The intention of a guide is to increases the awareness of information and approaches in a given subject area, as such this guide should serve as a collation of points to consider when determining a sample practice for PAT instruments. It is not intended to serve as a practice to be followed. As a first step, one should define the overall goal of the PAT measurement. Once defined, this guide describes various considerations as they relate to the specific requirements that must be met to achieve the overall PAT goal, including the attributes to be measured, impact of the scale of the process, and interfacing of the measurement system to manufacturing equipment (including sampling system reliability). Additionally, it discusses the estimation and validation of the effective sample size and the overall contribution to the measurement. Related aspects of data collection and data processing as well as the use of risk assessments to optimize sampling and to understand the impact of potential sampling errors are also covered. Furthermore, considerations for process control and aspects pertaining to sample withdrawal and retention are also included. Lastly, continuous manufacturing processes require special considerations due to the time dependency associated with continuous operations as compared to batch manufacturing and special considerations are needed for sampling of such processes.  
1.2 This guide is limited to a high level overview of sampling considerations for PAT applied to any type of pharmaceutical manufacturing (for example, active pharmaceutical ingredient (API), solid oral dosage form, etc.). It is not intended to provide technology- or application-specific sampling guidance, or both. Instead, the intent is to evoke a thought process around sampling when developing a PAT application. While the focus is mainly on sampling considerations for on/in-line applications in solids, liquids, and gases (that is, in situ PAT measurements), many of the considerations also apply to at-line and off-line applications in which a sample is withdrawn from the process and subsequently presented for analysis.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardizatio...

General Information

Status
Published
Publication Date
31-Aug-2018
ICS
71.120.01 - Equipment for the chemical industry in general
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.14 - Measurement Systems and Analysis
Current Stage
Ref Project

Relations

Refers
ASTM E456-13A(2017)e1 - Standard Terminology Relating to Quality and Statistics
Effective Date
01-Oct-2017
Refers
ASTM E456-13A(2017)e3 - Standard Terminology Relating to Quality and Statistics
Effective Date
01-Oct-2017
Refers
ASTM E1402-13(2018) - Standard Guide for Sampling Design
Effective Date
01-Nov-2018

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ASTM E3177-18 - Standard Guide on Sampling for Process Analytical TechnologyASTM E3177-18 - Standard Guide on Sampling for Process Analytical Technology
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ASTM E3177-18 - Standard Guide on Sampling for Process Analytical Technology
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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: E3177 − 18
Standard Guide on
1
Sampling for Process Analytical Technology
This standard is issued under the fixed designation E3177; 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 on/in-line applications in solids, liquids, and gases (that is, in
situ PAT measurements), many of the considerations also apply
1.1 This document is to be used as a guide to Process
to at-line and off-line applications in which a sample is
Analytical Technology (PAT) instrument sampling, and covers
withdrawn from the process and subsequently presented for
both the sample from which PAT data is collected and the
analysis.
sample that is taken for reference assay. The ASTM definition
1.3 This international standard was developed in accor-
of a guide is a compendium of information or series of options
dance with internationally recognized principles on standard-
that does not recommend a specific course of action. The
ization established in the Decision on Principles for the
intention of a guide is to increases the awareness of informa-
Development of International Standards, Guides and Recom-
tion and approaches in a given subject area, as such this guide
mendations issued by the World Trade Organization Technical
should serve as a collation of points to consider when deter-
Barriers to Trade (TBT) Committee.
mining a sample practice for PAT instruments. It is not
intended to serve as a practice to be followed. As a first step,
2. Referenced Documents
one should define the overall goal of the PAT measurement.
2
Once defined, this guide describes various considerations as
2.1 ASTM Standards:
they relate to the specific requirements that must be met to
D4177 Practice for Automatic Sampling of Petroleum and
achieve the overall PAT goal, including the attributes to be
Petroleum Products
measured, impact of the scale of the process, and interfacing of
E105 Guide for Probability Sampling of Materials
the measurement system to manufacturing equipment (includ-
E122 Practice for Calculating Sample Size to Estimate, With
ing sampling system reliability). Additionally, it discusses the
Specified Precision, the Average for a Characteristic of a
estimation and validation of the effective sample size and the
Lot or Process
overall contribution to the measurement. Related aspects of
E456 Terminology Relating to Quality and Statistics
data collection and data processing as well as the use of risk
E1402 Guide for Sampling Design
assessments to optimize sampling and to understand the impact
E2363 Terminology Relating to Manufacturing of Pharma-
of potential sampling errors are also covered. Furthermore,
ceutical and Biopharmaceutical Products in the Pharma-
considerations for process control and aspects pertaining to
ceutical and Biopharmaceutical Industry
sample withdrawal and retention are also included. Lastly,
3
2.2 ASME Standard:
continuous manufacturing processes require special consider-
ASME BPE Bioprocessing Equipment
ations due to the time dependency associated with continuous
operations as compared to batch manufacturing and special
3. Terminology
considerations are needed for sampling of such processes.
3.1 Definitions—For an extensive list of terminology related
1.2 This guide is limited to a high level overview of
to pharmaceutical manufacturing, refer to Terminology E2363.
sampling considerations for PAT applied to any type of
pharmaceutical manufacturing (for example, active pharma-
4. Significance and Use
ceutical ingredient (API), solid oral dosage form, etc.). It is not
4.1 Application of this guidance should enable PAT method
intended to provide technology- or application-specific sam-
developers to design and implement reliable PAT applications
pling guidance, or both. Instead, the intent is to evoke a thought
process around sampling when developing a PAT application.
While the focus is mainly on sampling considerations for
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 guide is under the jurisdiction of ASTM Committee E55 on Manufacture Standards volume information, refer to the standard’s Document Summary page on
of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of the ASTM website.
3
Subcommittee E55.14 on Measurement Systems and Analysis. Available from American Society of Mechanical Engineers (ASME), ASME
Curr
...

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5.1 This guide supports the principles of Guide E2500 and extends these principles to the verification of PAT-enabled control systems.  
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1.3 Principles described in this guide may be applied regardless of the complexity or scale of the PAT-enabled control system or whether applied to batch or continuous processing, or both. The intention of this standard is to describe and support the implementation of a PAT enabled Control Strategy, as described in ICH Q8(R2).  
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4.1 This guide is intended to provide a series of evaluations that will assist engineers dealing with chemical environments in selecting appropriate alloys (1-3). In chemical environments, an important issue for determining general corrosion resistance is the temperature at which an alloy transitions from corrosion at a low rate to corrosion at a much higher rate. Other important concerns include the tendency towards crevice corrosion and stress corrosion cracking resistance, especially in hot chloride-containing aqueous environments.  
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SCOPE
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4.1 The primary use of these test methods is testing to determine the specified mechanical properties of steel, stainless steel, and related alloy products for the evaluation of conformance of such products to a material specification under the jurisdiction of ASTM Committee A01 and its subcommittees as designated by a purchaser in a purchase order or contract.  
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Bend  
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Hardness  
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Brinell  
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Rockwell  
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Portable  
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Impact  
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Keywords  
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Annex A2  
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Annex A3  
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Annex A4  
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Annex A5  
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Annex A7  
Rounding of Test Data  
Annex A8  
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Annex A9  
Procedure for Use and Control of Heat-cycle Simulation  
Annex A10  
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SCOPE
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SCOPE
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1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined  
1.6 This standard shall not be used to describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual fire conditions. However, results of this test may be used as elements of a fire assessment that takes into account all of the factors, which are pertinent to an assessment of the fire hazard of a particular end use.  
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SCOPE
1.1 This practice covers the installation procedure for barbed tape.  
1.2 The primary purpose of this practice is to guide those responsible for or concerned with the installation of barbed tape on chain link fences, masonry walls, roofs or used as ground barriers. This standard is not intended to cover aspects of perimeter security for establishing levels of product performance or give analysis relating to various design comparisons.  
1.3 This standard involves the use of material, that may cause injury, including exposure to hazardous materials, and operation of specialized equipment.  
1.4 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.  
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.

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