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ASTM E2629-11

(Guide)

Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

SIGNIFICANCE AND USE
This guide supports the principles of Guide E2500 and extends these principles to the verification of PAT-enabled control systems.
This guide clarifies what is important for verification of PAT-enabled control systems. Such systems are often complex and require multidisciplinary and cross-functional teams to achieve optimum results. This guide provides a common basis for understanding requirements for all involved disciplines such as control engineering, development, manufacturing, and process validation.
SCOPE
1.1 This guide describes the verification of process analytical technology (PAT) enabled control systems using a science- and risk-based approach. It establishes principles for determining the scope and extent of verification activities necessary to ensure that the PAT-enabled control system is fit for purpose, properly implemented, and functions as expected.
1.2 In this guide, a PAT-enabled control system is considered to be the system that adjusts the manufacturing process using timely measurements (that is, during processing) of attributes of raw and in-process materials to determine responses that assure the process remains within specified boundaries and minimizes variability in the output material. The overall aim of the PAT-enabled control system is to ensure product quality. The PAT-enabled control system of a manufacturing process provides the capability to determine the current status of the process and drive the process to ensure the output material has the desired quality characteristics. The control system should be able to respond to process variations in a timely manner, providing corrections that ensure that the process follows the desired process trajectory to reach the desired outcome. PAT-enabled control systems may use process models based on first principles understanding or empirical models derived from experimental investigations or both. In addition to automated controls, a PAT-enabled control system may include components where there is manual intervention.
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.
1.4 The principles described in this guide are applicable to a PAT-enabled control system and also to its component subsystems. This guide does not cover the requirements for continuous quality verification of the overall process, which are covered in Guide E2537.
1.5 For information on science- and risk-based approaches in the pharmaceutical industry, reference should be made to ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT systems in the pharmaceutical industry, reference should be made to FDA Guidance for IndustryPAT and FDA Guidance for IndustryProcess Validation.
1.6 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
Historical
Publication Date
14-Apr-2011
ICS
71.120.01 - Equipment for the chemical industry in general
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.01 - Process Understanding and PAT System Management, Implementation and Practice
Current Stage
Ref Project

Relations

Replaced By
ASTM E2629-19 - Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
Effective Date
15-Jun-2019
Referred By
ASTM E2898-20a - Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
Effective Date
15-Apr-2011
Referred By
ASTM E2968-23 - Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry
Effective Date
15-Apr-2011
Referred By
ASTM E2500-20 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
Effective Date
15-Apr-2011
Referred By
ASTM E2476-22 - Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
Effective Date
15-Apr-2011
Referred By
ASTM E2986-22 - Standard Guide for Evaluation of Environmental Aspects of Sustainability of Manufacturing Processes
Effective Date
15-Apr-2011
Referred By
ASTM E2363-23 - Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
Effective Date
15-Apr-2011

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ASTM E2629-11 - Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control SystemsASTM E2629-11 - Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
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ASTM E2629-11 - Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E2629 −11
Standard Guide for
Verification of Process Analytical Technology (PAT) Enabled
1
Control Systems
This standard is issued under the fixed designation E2629; 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 continuous quality verification of the overall process, which
are covered in Guide E2537.
1.1 This guide describes the verification of process analyti-
1.5 For information on science- and risk-based approaches
cal technology (PAT) enabled control systems using a science-
and risk-based approach. It establishes principles for determin- in the pharmaceutical industry, reference should be made to
ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT
ing the scope and extent of verification activities necessary to
ensure that the PAT-enabled control system is fit for purpose, systems in the pharmaceutical industry, reference should be
made to FDA Guidance for Industry—PAT and FDA Guidance
properly implemented, and functions as expected.
for Industry—Process Validation.
1.2 In this guide, a PAT-enabled control system is consid-
1.6 This standard does not purport to address all of the
ered to be the system that adjusts the manufacturing process
safety concerns, if any, associated with its use. It is the
using timely measurements (that is, during processing) of
responsibility of the user of this standard to establish appro-
attributes of raw and in-process materials to determine re-
priate safety and health practices and determine the applica-
sponses that assure the process remains within specified
bility of regulatory limitations prior to use.
boundaries and minimizes variability in the output material.
1.7 This international standard was developed in accor-
The overall aim of the PAT-enabled control system is to ensure
dance with internationally recognized principles on standard-
product quality. The PAT-enabled control system of a manu-
ization established in the Decision on Principles for the
facturing process provides the capability to determine the
Development of International Standards, Guides and Recom-
current status of the process and drive the process to ensure the
output material has the desired quality characteristics. The mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
control system should be able to respond to process variations
in a timely manner, providing corrections that ensure that the
process follows the desired process trajectory to reach the 2. Referenced Documents
desired outcome. PAT-enabled control systems may use pro- 2
2.1 ASTM Standards:
cess models based on first principles understanding or empiri-
E122 Practice for Calculating Sample Size to Estimate,With
cal models derived from experimental investigations or both.
Specified Precision, the Average for a Characteristic of a
In addition to automated controls, a PAT-enabled control
Lot or Process
system may include components where there is manual inter-
E2363 Terminology Relating to ProcessAnalytical Technol-
vention.
ogy in the Pharmaceutical Industry
1.3 Principles described in this guide may be applied E2476 Guide for Risk Assessment and Risk Control as it
regardless of the complexity or scale of the PAT-enabled Impacts the Design, Development, and Operation of PAT
control system or whether applied to batch or continuous Processes for Pharmaceutical Manufacture
processing, or both. E2500 Guide for Specification, Design, and Verification of
Pharmaceutical and Biopharmaceutical Manufacturing
1.4 The principles described in this guide are applicable to
Systems and Equipment
a PAT-enabled control system and also to its component
E2537 Guide for Application of Continuous Process Verifi-
subsystems. This guide does not cover the requirements for
cation to Pharmaceutical and Biopharmaceutical Manu-
facturing
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture
ofPharmaceuticalandBiopharmaceuticalProductsandisthedirectresponsibilityof
2
Subcommittee E55.01 on Process Understanding and PAT System Management, For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Implementation and Practice. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved April 15, 2011. Published May 2011. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
E2629-11. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2629−11
2.
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SIGNIFICANCE AND USE
5.1 This guide supports the principles of Guide E2500 and extends these principles to the verification of PAT-enabled control systems.  
5.2 This guide clarifies what is important for verification of PAT-enabled control systems. Such systems are often complex and require multidisciplinary and cross-functional teams to achieve optimum results. This guide provides a common basis for understanding requirements for all involved disciplines such as control engineering, development, manufacturing, and process validation.
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1.1 This guide describes the verification of process analytical technology (PAT) enabled control systems using a science- and risk-based approach. It establishes principles for determining the scope and extent of verification activities necessary to ensure that the PAT-enabled control system is fit for purpose, properly implemented, and functions as expected.  
1.2 In this guide, a PAT-enabled control system is considered to be the system that adjusts the manufacturing process using timely measurements (that is, during processing) of attributes of raw and in-process materials to determine responses that assure the process remains within specified boundaries and minimizes variability in the output material. The overall aim of the PAT-enabled control system is to ensure product quality. The PAT-enabled control system of a manufacturing process provides the capability to determine the current status of the process and drive the process to ensure the output material has the desired quality characteristics. The control system should be able to respond to process variations in a timely manner, providing corrections that ensure that the process follows the desired process trajectory to reach the desired outcome. PAT-enabled control systems may use process models based on first principles understanding or empirical models derived from experimental investigations or both. In addition to automated controls, a PAT-enabled control system may include components where there is manual intervention.  
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).  
1.4 The principles described in this guide are applicable to a PAT-enabled control system and also to its component subsystems. This guide does not cover the requirements for continuous quality verification of the overall process, which are covered in Guide E2537, or for validation of PAT methods, which is covered in Guide E2898.  
1.5 For information on science- and risk-based approaches in the pharmaceutical industry, reference should be made to ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT systems in the pharmaceutical industry, reference should be made to FDA Guidance for Industry—PAT and FDA Guidance for Industry—Process Validation, as well as EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use and EU Guideline on Process Validation for Finished Products.  
1.6 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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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.  
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SIGNIFICANCE AND USE
5.1 This guide supports the principles of Guide E2500 and extends these principles to the verification of PAT-enabled control systems.  
5.2 This guide clarifies what is important for verification of PAT-enabled control systems. Such systems are often complex and require multidisciplinary and cross-functional teams to achieve optimum results. This guide provides a common basis for understanding requirements for all involved disciplines such as control engineering, development, manufacturing, and process validation.
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1.2 In this guide, a PAT-enabled control system is considered to be the system that adjusts the manufacturing process using timely measurements (that is, during processing) of attributes of raw and in-process materials to determine responses that assure the process remains within specified boundaries and minimizes variability in the output material. The overall aim of the PAT-enabled control system is to ensure product quality. The PAT-enabled control system of a manufacturing process provides the capability to determine the current status of the process and drive the process to ensure the output material has the desired quality characteristics. The control system should be able to respond to process variations in a timely manner, providing corrections that ensure that the process follows the desired process trajectory to reach the desired outcome. PAT-enabled control systems may use process models based on first principles understanding or empirical models derived from experimental investigations or both. In addition to automated controls, a PAT-enabled control system may include components where there is manual intervention.  
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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.
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This specification covers hot- and cold-worked precipitation-hardenable nickel alloy rod, bar, forgings, and forging stock for high-temperature service. Chemical analysis shall be performed on the alloy and shall conform to the chemical composition requirement in carbon, manganese, silicon, phosphorus, sulfur, chromium, cobalt, molybdenum, columbium, tantalum, titanium, aluminum, zirconium, boron, iron, copper, and nickel. The material shall follow recommended annealing treatment, solution treatment, stabilizing treatment, and precipitation hardening treatment. Tension testing, hardness testing and stress-rupture testing shall be performed on the material and shall comply to the required tensile strength, yield strength, elongation, reduction in area, and Brinell hardness.
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SCOPE
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ASTM
ASTM D8139-23(Specification)
Standard Specification for Semi-Rigid, Closed-Cell Polypropylene Foam, Preformed Expansion Joint Fillers for Concrete Paving and Structural Construction

SCOPE
1.1 This specification covers preformed expansion joint fillers made from closed-cell polypropylene foam materials having suitable compressibility, recovery from compression, nonextruding, and weather-resistant characteristics.  
1.1.1 Type I, closed-cell polypropylene foam.  
1.2 These joint fillers are intended for use in concrete pavements in full-depth joints. There are several variations in size with typical thicknesses of 1/2 in. (12.7 mm), 3/4 in. (19.05 mm), and 1 in. (25.4 mm); typical widths of 31/2 in. (88.9 mm), 4 in. (101.6 mm), 5 in. (127 mm), 6 in. (152.5 mm), 7 in. (177.8 mm), 8 in. (203.2 mm), or 48 in. (1.2 m) sheet; and typical lengths of 5 ft (1.52 m) and 10 ft (3.05 m).  
1.3 The values stated in inch-pound units are to be regarded as the 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.  
1.5 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.

  • Technical specification
    2 pages
    English language
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  • Technical specification
    2 pages
    English language
    sale 15% off