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ASTM E 2656 : 2016

Current

Current

The latest, up-to-date edition.

Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-08-2023

€56.53
Excluding VAT

1.1 This practice establishes an approach to the real-time release testing (RTRT) of pharmaceutical water based on the total organic carbon (TOC) attribute using on-line total organic carbon (OLTOC) instrumentation that is in agreement with current regulatory thinking.

Committee
E 55
DocumentType
Standard Practice
Pages
8
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1This practice establishes an approach to the real-time release testing (RTRT) of pharmaceutical water based on the total organic carbon (TOC) attribute using on-line total organic carbon (OLTOC) instrumentation that is in agreement with current regulatory thinking.

1.2This practice is harmonized with or supports the concepts of relevant ASTM International Committee E55 on Manufacture of Pharmaceutical Products standards, ICH Harmonized Tripartite Guidelines, the U.S. FDA PAT Guidance, and U.S. FDA Pharmaceutical cGMPs.

1.3This practice does not provide general guidance information for pharmaceutical procedures that are considered standard practice in the pharmaceutical industry. This practice provides specific guidance for non-standardized procedures.

1.4This practice does not address the user’s various internal procedures for risk, change, or quality management systems. The overall project effort associated with this practice shall be proportional to the overall risk of failing the pharmaceutical water’s TOC concentration specification.

1.5This practice does not purport to establish how to comply with pharmacopeias. The RTRT methodology selected must assure compliance with the user’s current required pharmacopeias. However, compliance with pharmacopeia TOC methods is not necessarily sufficient to meet current regulatory expectations for RTRT.

1.6This practice does not purport to substitute for or replace compendial bioburden testing requirements. It is strictly applicable to the TOC attribute of water quality.

1.7This 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.

ASTM E 2898 : 2020 : REV A Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
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ASTM D 5904 : 2002 Standard Test Method for Total Carbon, Inorganic Carbon, and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM D 6317 : 1998 : R2004 Standard Test Method for Low Level Determination of Total Carbon, Inorganic Carbon and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM E 2363 : 2005 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2005 : REV B Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2023 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
ASTM E 2500 : 2020 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2500 : 2007 : R2012 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2281 : 2015 Standard Practice for Process Capability and Performance Measurement
ASTM D 6317 : 1998 : R2009 Standard Test Method for Low Level Determination of Total Carbon, Inorganic Carbon and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM D 5904 : 1996 Standard Test Method for Total Carbon, Inorganic Carbon, and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM E 2281 : 2003 Standard Practice for Process and Measurement Capability Indices
ASTM D 5997 : 1996 : R2009 Standard Test Method for On-Line Monitoring of Total Carbon, Inorganic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM D 5173 : 1997 : R2001 Standard Test Method for On-Line Monitoring of Carbon Compounds in Water by Chemical Oxidation, by UV Light Oxidation, by Both or by High Temperature Combustion Followed by Gas Phase NDIR or by Electrolytic Conductivity
ASTM D 5997 : 2015 Standard Test Method for On-Line Monitoring of Total Carbon, Inorganic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM E 2500 : 2007 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM D 5904 : 2002 : R2017 Standard Test Method for Total Carbon, Inorganic Carbon, and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM D 5997 : 1996 : R2000 Standard Test Method for On-Line Monitoring of Total Carbon, Inorganic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM D 5997 : 1996 : R2005 Standard Test Method for On-Line Monitoring of Total Carbon, Inorganic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM D 4839 : 1994 Standard Test Method for Total Carbon and Organic Carbon in Water by Ultraviolet, or Persulfate Oxidation, or Both, and Infrared Detection
ASTM E 2537 : 2016 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
ASTM D 4839 : 2003 : R2024 Standard Test Method for Total Carbon and Organic Carbon in Water by Ultraviolet, or Persulfate Oxidation, or Both, and Infrared Detection
ASTM E 2363 : 2004 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2281 : 2008 Standard Practice for Process and Measurement Capability Indices
ASTM D 6317 : 2015 Standard Test Method for Low Level Determination of Total Carbon, Inorganic Carbon and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM E 2363 : 2006 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM D 5173 : 1997 : R2007 Standard Test Method for On-Line Monitoring of Carbon Compounds in Water by Chemical Oxidation, by UV Light Oxidation, by Both, or by High Temperature Combustion Followed by Gas Phase NDIR or by Electrolytic Conductivity
ASTM E 2537 : 2008 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing
ASTM E 2500 : 2013 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM D 5904 : 2002 : R2024 Standard Test Method for Total Carbon, Inorganic Carbon, and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM D 4839 : 2003 : R2017 Standard Test Method for Total Carbon and Organic Carbon in Water by Ultraviolet, or Persulfate Oxidation, or Both, and Infrared Detection
ASTM D 5904 : 2002 : R2009 Standard Test Method for Total Carbon, Inorganic Carbon, and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM D 5173 : 2015 : R2023 Standard Guide for On-Line Monitoring of Total Organic Carbon in Water by Oxidation and Detection of Resulting Carbon Dioxide
ASTM E 2363 : 2004 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2281 : 2008 : REV A Standard Practice for Process and Measurement Capability Indices
ASTM D 4839 : 2003 Standard Test Method for Total Carbon and Organic Carbon in Water by Ultraviolet, or Persulfate Oxidation, or Both, and Infrared Detection
ASTM D 5173 : 2015 Standard Guide for On-Line Monitoring of Total Organic Carbon in Water by Oxidation and Detection of Resulting Carbon Dioxide
ASTM D 5997 : 2015 : R2024 Standard Test Method for On-Line Monitoring of Total Carbon, Inorganic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM E 2363 : 2005 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2006 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2281 : 2008 : REV A : R2012 : EDT 1 Standard Practice for Process and Measurement Capability Indices
ASTM D 6317 : 2015 : R2024 Standard Test Method for Low Level Determination of Total Carbon, Inorganic Carbon and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM D 6317 : 1998 Standard Test Method for Low Level Determination of Total Carbon, Inorganic Carbon and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
ASTM D 4839 : 2003 : R2011 Standard Test Method for Total Carbon and Organic Carbon in Water by Ultraviolet, or Persulfate Oxidation, or Both, and Infrared Detection
ASTM E 2363 : 2014 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

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