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ASTM E2656-16

(Practice)

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

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

SIGNIFICANCE AND USE
5.1 Pharmaceutical water is the most common component or ingredient used in pharmaceutical and biopharmaceutical manufacturing. Acceptable purity of the water is important to the quality of the final pharmaceutical product. TOC concentration is a key indicator and attribute of the purity of this water and also an important monitor of the overall performance of the water purification system. TOC analysis is the measurement of all the covalently bound carbon present in the water, not including carbon in the form of carbon dioxide (CO2), bicarbonate icon (HCO3 –), or carbonate ion (CO3 2–), and is reported as the mass of organic carbon per volume.  
5.2 Application of this practice provides pertinent information to make informed decisions on the release of water meeting pharmaceutical TOC concentration specifications.
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.

General Information

Status
Published
Publication Date
31-Oct-2016
ICS
11.120.10 - Medicaments
13.060.50 - Examination of water for chemical substances
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.12 - Process Applications
Current Stage
Ref Project

Relations

Refers
ASTM D6317-15 - 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
Effective Date
01-May-2015
Refers
ASTM D5904-02(2017) - Standard Test Method for Total Carbon, Inorganic Carbon, and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
Effective Date
01-Feb-2017

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Standards Content (Sample)

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.
Designation: E2656 − 16
Standard Practice for
Real-time Release Testing of Pharmaceutical Water for the
1
Total Organic Carbon Attribute
This standard is issued under the fixed designation E2656; 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 2. Referenced Documents
2
1.1 This practice establishes an approach to the real-time 2.1 ASTM Standards:
release testing (RTRT) of pharmaceutical water based on the E2281 Practice for Process Capability and Performance
total organic carbon (TOC) attribute using on-line total organic Measurement
carbon (OLTOC) instrumentation that is in agreement with E2363 Terminology Relating to Manufacturing of Pharma-
current regulatory thinking. ceutical and Biopharmaceutical Products in the Pharma-
ceutical and Biopharmaceutical Industry
1.2 This practice is harmonized with or supports the con-
E2500 Guide for Specification, Design, and Verification of
cepts of relevant ASTM International Committee E55 on
Pharmaceutical and Biopharmaceutical Manufacturing
Manufacture of Pharmaceutical Products standards, ICH Har-
Systems and Equipment
monized Tripartite Guidelines, the U.S. FDA PAT Guidance,
E2537 Guide for Application of Continuous Process Verifi-
and U.S. FDA Pharmaceutical cGMPs.
cation to Pharmaceutical and Biopharmaceutical Manu-
1.3 This practice does not provide general guidance infor-
facturing
mation for pharmaceutical procedures that are considered
D4839 Test Method for Total Carbon and Organic Carbon in
standard practice in the pharmaceutical industry. This practice
Water by Ultraviolet, or Persulfate Oxidation, or Both, and
provides specific guidance for non-standardized procedures.
Infrared Detection
1.4 This practice does not address the user’s various internal D5173 Guide for On-Line Monitoring of Total Organic
Carbon in Water by Oxidation and Detection of Resulting
procedures for risk, change, or quality management systems.
The overall project effort associated with this practice shall be Carbon Dioxide
D5904 Test Method for Total Carbon, Inorganic Carbon, and
proportional to the overall risk of failing the pharmaceutical
Organic Carbon in Water by Ultraviolet, Persulfate
water’s TOC concentration specification.
Oxidation, and Membrane Conductivity Detection
1.5 This practice does not purport to establish how to
D5997 Test Method for On-Line Monitoring of Total
comply with pharmacopeias. The RTRT methodology selected
Carbon, Inorganic Carbon in Water by Ultraviolet, Persul-
must assure compliance with the user’s current required
fate Oxidation, and Membrane Conductivity Detection
pharmacopeias. However, compliance with pharmacopeia TOC
D6317 Test Method for Low Level Determination of Total
methods is not necessarily sufficient to meet current regulatory
Carbon, Inorganic Carbon and Organic Carbon in Water
expectations for RTRT.
by Ultraviolet, Persulfate Oxidation, and Membrane Con-
1.6 This practice does not purport to substitute for or replace
ductivity Detection
compendial bioburden testing requirements. It is strictly appli-
2.2 Pharmacopoeia Documents:
cable to the TOC attribute of water quality.
ICH Q2 (R1) Validation of Analytical Procedures: Text and
3
1.7 This standard does not purport to address all of the
Methodology
safety concerns, if any, associated with its use. It is the
ICH Q7 Good Manufacturing Practice Guide for Active
3
responsibility of the user of this standard to establish appro-
Pharmaceutical Ingredients
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
1
This practice is under the jurisdiction of ASTM Committee E55 on Manufac- Standards volume information, refer to the standard’s Document Summary page on
ture of Pharmaceutical and Biopharmaceutical Products and is the direct responsi- the ASTM website.
3
bility of Subcommittee E55.12 on Process Applications. Available from International Conference on Harmonisation of Technical
Current edition approved Nov. 1, 2016. Published November 2016. Originally Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
approved in 2010. Last previous edition approved in 2010 as E2656 – 10. DOI: Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20,
10.1520/E2656-16. Switzerland, http://www.ich.
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2656 − 10 E2656 − 16
Standard Practice for
Real-time Release Testing of Pharmaceutical Water for the
1
Total Organic Carbon Attribute
This standard is issued under the fixed designation E2656; 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
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 USU.S. FDA PAT Guidance, and USU.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.
2. Referenced Documents
2
2.1 ASTM Standards:
E2281 Practice for Process Capability and Performance Measurement
E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
E2500 Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and
Equipment
E2537 Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing
D4839 Test Method for Total Carbon and Organic Carbon in Water by Ultraviolet, or Persulfate Oxidation, or Both, and Infrared
Detection
D5173 Guide for On-Line Monitoring of Total Organic Carbon in Water by Oxidation and Detection of Resulting Carbon
Dioxide
D5904 Test Method for Total Carbon, Inorganic Carbon, and Organic Carbon in Water by Ultraviolet, Persulfate Oxidation, and
Membrane Conductivity Detection
1
This practice is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of
Subcommittee E55.03 on General Pharmaceutical Standards.
Current edition approved Aug. 1, 2010Nov. 1, 2016. Published October 2010November 2016. Originally approved in 2010. Last previous edition approved in 2010 as
E2656 – 10. DOI: 10.1520/E2656-10.10.1520/E2656-16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2656 − 16
D5997 Test Method for On-Line Monitoring of Total Carbon, Inorganic Carbon in Water by Ultraviolet, Persulfate Oxidation,
and Membrane Conductivity Detection
D6317 Test Method for Low Level Determination of Total Carbon, Inorganic Carbon and Organic Carbon in Water by
Ultraviolet, Persulfate Oxidation, and Membrane Conductivity Detection
2.2 Pharmacopoeia Documents:
3
ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology
3
ICH Q7 Good Manufacturing Practice
...

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1.3 A complete listing of pesticides and other semivolatile organic chemicals for which this practice has been tested is shown in Table 1.  
1.4 This practice is based on the collection of chemicals from air onto polyurethane foam (PUF) or a combination of PUF and granular sorbent (for example, diphenyl oxide, styrene-divinylbenzene), or a granular sorbent alone.  
1.5 This practice is applicable to multicomponent atmospheres, 0.001 μg/m3 to 50 μg/m3 concentrations, and 4 h to 24 h sampling periods. The limit of detection will depend on the nature of the analyte and the length of the sampling period.  
1.6 The analytical method(s) recommended will depend on the specific chemical(s) sought, the concentration level, and the degree of specificity required.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 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. For specific hazards statements, see 10.24 and A1.1.  
1.9 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.

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ASTM
ASTM A747/A747M-23(Specification)
Standard Specification for Steel Castings, Stainless, Precipitation Hardening

ABSTRACT
This specification covers iron-chromium-nickel-copper corrosion resistance steel castings capable of being strengthened by precipitation hardening heat treatment. The steel shall be made by electric furnace process with or without separate refining such as argon-oxygen decarburization. The steel materials shall also undergo homogenization heat treatment, solution annealing heat treatment, precipitation hardening and shall conform to the required values of temperature and time and cooling treatment. The materials shall conform to the required chemical compositions of carbon, manganese, phosphorus, sulfur, silicon, chromium, nickel, copper, columbium, and nitrogen.
SCOPE
1.1 This specification covers iron-chromium-nickel-copper corrosion-resistant steel castings, capable of being strengthened by precipitation hardening heat treatment.  
1.2 These castings may be used in services requiring corrosion resistance and high strengths at temperatures up to 600 °F [315 °C]. They may be machined in the solution heat-treated condition and subsequently precipitation hardened to the desired high-strength mechanical properties specified in Table S51.1 with little danger of cracking or distortion.  
1.3 The material is not intended for use in the solution heat-treated condition.  
Note 1: If the service environment in which the material is to be used is considered conducive to stress-corrosion cracking, precipitation hardening should be performed at a temperature that will minimize the susceptibility of the material to this type of attack.  
1.4 Supplementary requirements of an optional nature are provided for use at the option of the purchaser. The supplementary requirements shall apply only when specified individually by the purchaser in the purchase order or contract.  
1.5 This specification is expressed in both inch-pound units and in SI units; however, unless the purchase order or contract specifies the applicable M-specification designation (SI units), the inch-pound units shall apply.  
1.6 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard. Within the text, the SI units are shown in brackets.  
1.7 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.

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ASTM
ASTM D6281-23(Test Method)
Standard Test Method for Airborne Asbestos Concentration in Ambient and Indoor Atmospheres as Determined by Transmission Electron Microscopy Direct Transfer (TEM)

SIGNIFICANCE AND USE
5.1 This test method is applicable to the measurement of airborne asbestos in a wide range of ambient air situations and for detailed evaluation of any atmosphere for asbestos structures. Most fibers in ambient atmospheres are not asbestos, and therefore, there is a requirement for fibers to be identified. Most of the airborne asbestos fibers in ambient atmospheres have diameters below the resolution limit of the light microscope. This test method is based on transmission electron microscopy, which has adequate resolution to allow detection of small thin fibers and is currently the only technique capable of unequivocal identification of the majority of individual fibers of asbestos. Asbestos is often found, not as single fibers, but as very complex, aggregated structures, which may or may not also be aggregated with other particles. The fibers found suspended in an ambient atmosphere can often be identified unequivocally if sufficient measurement effort is expended. However, if each fiber were to be identified in this way, the analysis would become prohibitively expensive. Because of instrumental deficiencies or because of the nature of the particulate matter, some fibers cannot be positively identified as asbestos even though the measurements all indicate that they could be asbestos. Therefore, subjective factors contribute to this measurement, and consequently, a very precise definition of the procedure for identification and enumeration of asbestos fibers is required. The method defined in this test method is designed to provide a description of the nature, numerical concentration, and sizes of asbestos-containing particles found in an air sample. The test method is necessarily complex because the structures observed are frequently very complex. The method of data recording specified in the test method is designed to allow reevaluation of the structure-counting data as new applications for measurements are developed. All of the feasible specimen preparation techn...
SCOPE
1.1 This test method2 is an analytical procedure using transmission electron microscopy (TEM) for the determination of the concentration of asbestos structures in ambient atmospheres and includes measurement of the dimension of structures and of the asbestos fibers found in the structures from which aspect ratios are calculated.  
1.1.1 This test method allows determination of the type(s) of asbestos fibers present.  
1.1.2 This test method cannot always discriminate between individual fibers of the asbestos and non-asbestos analogues of the same amphibole mineral.  
1.2 This test method is suitable for determination of asbestos in both ambient (outdoor) and building atmospheres.  
1.2.1 This test method is defined for polycarbonate capillary-pore filters or cellulose ester (either mixed esters of cellulose or cellulose nitrate) filters through which a known volume of air has been drawn and for blank filters.  
1.3 The upper range of concentrations that can be determined by this test method is 7000 s/mm2. The air concentration represented by this value is a function of the volume of air sampled.  
1.3.1 There is no lower limit to the dimensions of asbestos fibers that can be detected. In practice, microscopists vary in their ability to detect very small asbestos fibers. Therefore, a minimum length of 0.5 μm has been defined as the shortest fiber to be incorporated in the reported results.  
1.4 The direct analytical method cannot be used if the general particulate matter loading of the sample collection filter as analyzed exceeds approximately 10 % coverage of the collection filter by particulate matter.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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 appropri...

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