ASTM E2629 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
Данный раздел/документ содержится в продуктах:
- Техэксперт: Машиностроительный комплекс
- Картотека зарубежных и международных стандартов
- ASTM E3012 Standard Guide for Characterizing Environmental Aspects of Manufacturing Processes
- ASTM D7202 Standard Test Method for Determination of Beryllium in the Workplace by Extraction and Optical Fluorescence Detection
- ASTM D4840 Standard Guide for Sample Chain-of-Custody Procedures
- ASTM D7859 Standard Practice for Spraying, Sampling, Packaging, and Test Specimen Preparation of Spray Polyurethane Foam (SPF) Insulation for Testing of Emissions Using Environmental Chambers
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ASTM D6196 Standard Practice for Selection of Sorbents, Sampling, and Thermal Desorption Analysis Procedures for Volatile Organic Compounds in Air
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D7859 Standard Practice for Spraying, Sampling, Packaging, and Test Specimen Preparation of Spray Polyurethane Foam (SPF) Insulation for Testing of Emissions Using Environmental Chambers
- ASTM D4840 Standard Guide for Sample Chain-of-Custody Procedures
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- ASTM D7202 Standard Test Method for Determination of Beryllium in the Workplace by Extraction and Optical Fluorescence Detection
- ASTM D4840 Standard Guide for Sample Chain-of-Custody Procedures
- ASTM D7859 Standard Practice for Spraying, Sampling, Packaging, and Test Specimen Preparation of Spray Polyurethane Foam (SPF) Insulation for Testing of Emissions Using Environmental Chambers
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ASTM D6196 Standard Practice for Selection of Sorbents, Sampling, and Thermal Desorption Analysis Procedures for Volatile Organic Compounds in Air
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D7859 Standard Practice for Spraying, Sampling, Packaging, and Test Specimen Preparation of Spray Polyurethane Foam (SPF) Insulation for Testing of Emissions Using Environmental Chambers
- ASTM D4840 Standard Guide for Sample Chain-of-Custody Procedures
- 13.040
- ASTM D7202 Standard Test Method for Determination of Beryllium in the Workplace by Extraction and Optical Fluorescence Detection
- ASTM D4840 Standard Guide for Sample Chain-of-Custody Procedures
- ASTM D7859 Standard Practice for Spraying, Sampling, Packaging, and Test Specimen Preparation of Spray Polyurethane Foam (SPF) Insulation for Testing of Emissions Using Environmental Chambers
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ASTM D6196 Standard Practice for Selection of Sorbents, Sampling, and Thermal Desorption Analysis Procedures for Volatile Organic Compounds in Air
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D7859 Standard Practice for Spraying, Sampling, Packaging, and Test Specimen Preparation of Spray Polyurethane Foam (SPF) Insulation for Testing of Emissions Using Environmental Chambers
- ASTM D4840 Standard Guide for Sample Chain-of-Custody Procedures
- ASTM D7202 Standard Test Method for Determination of Beryllium in the Workplace by Extraction and Optical Fluorescence Detection
- ASTM D7202 Standard Test Method for Determination of Beryllium in the Workplace by Extraction and Optical Fluorescence Detection
- ASTM D4840 Standard Guide for Sample Chain-of-Custody Procedures
- ASTM D7859 Standard Practice for Spraying, Sampling, Packaging, and Test Specimen Preparation of Spray Polyurethane Foam (SPF) Insulation for Testing of Emissions Using Environmental Chambers
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ASTM D6196 Standard Practice for Selection of Sorbents, Sampling, and Thermal Desorption Analysis Procedures for Volatile Organic Compounds in Air
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D7859 Standard Practice for Spraying, Sampling, Packaging, and Test Specimen Preparation of Spray Polyurethane Foam (SPF) Insulation for Testing of Emissions Using Environmental Chambers
- ASTM D7859 Standard Practice for Spraying, Sampling, Packaging, and Test Specimen Preparation of Spray Polyurethane Foam (SPF) Insulation for Testing of Emissions Using Environmental Chambers
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ASTM D6196 Standard Practice for Selection of Sorbents, Sampling, and Thermal Desorption Analysis Procedures for Volatile Organic Compounds in Air
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D7706 Standard Practice for Rapid Screening of VOC Emissions from Products Using Micro-Scale Chambers
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ASTM D6196 Standard Practice for Selection of Sorbents, Sampling, and Thermal Desorption Analysis Procedures for Volatile Organic Compounds in Air
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ASTM D5197 Standard Test Method for Determination of Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler Methodology)
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ASTM D6196 Standard Practice for Selection of Sorbents, Sampling, and Thermal Desorption Analysis Procedures for Volatile Organic Compounds in Air
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ISO 10580 Resilient, textile and laminate floor coverings — Test method for volatile organic compound (VOC) emissions - First Edition
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ASTM D6196 Standard Practice for Selection of Sorbents, Sampling, and Thermal Desorption Analysis Procedures for Volatile Organic Compounds in Air
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ASTM D7339 Standard Test Method for Determination of Volatile Organic Compounds Emitted from Carpet using a Specific Sorbent Tube and Thermal Desorption / Gas Chromatography
- ASTM D6196 Standard Practice for Selection of Sorbents, Sampling, and Thermal Desorption Analysis Procedures for Volatile Organic Compounds in Air
- ASTM D6196 Standard Practice for Selection of Sorbents, Sampling, and Thermal Desorption Analysis Procedures for Volatile Organic Compounds in Air
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- Картотека зарубежных и международных стандартов
ASTM International
Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
N E2629
Annotation
This guide describes the verification of process analytical technology (PAT) enabled control systems using a scienceand 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.
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.
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 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.
