ASTM E2656-16
Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

Standard No.

ASTM E2656-16

Release Date

2016

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM E2656-16

Scope

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. 1.2 This 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. 1.3 This 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. 1.4 This 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. 1.5 This 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. 1.6 This practice does not purport to substitute for or replace compendial bioburden testing requirements. It is strictly applicable to the TOC attribute of water quality. 1.7 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.

ASTM E2656-16 Referenced Document

• ASTM D4839 Standard Test Method for Total Carbon and Organic Carbon in Water by Ultraviolet, or Persulfate Oxidation, or Both, and Infrared Detection
• ASTM D5173 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 D5904 Standard Test Method for Total Carbon, Inorganic Carbon, and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
• ASTM D5997 Standard Test Method for On-Line Monitoring of Total Carbon, Inorganic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
• ASTM D6317 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 E2281 Standard Practice for Process Capability and Performance Measurement*， 2020-10-01 Update
• ASTM E2363 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry*， 2023-01-01 Update
• ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment*， 2020-10-01 Update
• ASTM E2537 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing*， 2016-12-01 Update
• ISO 15839 Water quality - On-line sensors/analysing equipment for water - Specifications and performance tests

ASTM E2656-16 history

• 2016 ASTM E2656-16 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
• 2010 ASTM E2656-10 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute