ASTM E 2656 : 2016
Current
The latest, up-to-date edition.
Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
Hardcopy , PDF
English
10-08-2023
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 |
ASTM E 2898 : 2014 | Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications |
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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.