ASTM Volume 14.05, July 2018

    Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical and Biopharmaceutical Products

    Table of Contents

    E29-13 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications

    E105-16 Standard Practice for Probability Sampling of Materials

    E122-17 Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process

    E141-10(2018) Standard Practice for Acceptance of Evidence Based on the Results of Probability Sampling

    E177-14 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods

    E178-16a Standard Practice for Dealing With Outlying Observations

    E228-17 Standard Test Method for Linear Thermal Expansion of Solid Materials With a Push-Rod Dilatometer

    E289-17 Standard Test Method for Linear Thermal Expansion of Rigid Solids with Interferometry

    E456-13A(2017)e2 Standard Terminology Relating to Quality and Statistics

    E473-16 Standard Terminology Relating to Thermal Analysis and Rheology

    E487-14 Standard Test Method for Constant-Temperature Stability of Chemical Materials

    E502-07(2013) Standard Test Method for Selection and Use of ASTM Standards for the Determination of Flash Point of Chemicals by Closed Cup Methods

    E537-12 Standard Test Method for The Thermal Stability of Chemicals by Differential Scanning Calorimetry

    E582-07(2013)e1 Standard Test Method for Minimum Ignition Energy and Quenching Distance in Gaseous Mixtures

    E659-15 Standard Test Method for Autoignition Temperature of Chemicals

    E680-79(2011)e1 Standard Test Method for Drop Weight Impact Sensitivity of Solid-Phase Hazardous Materials

    E681-09(2015) Standard Test Method for Concentration Limits of Flammability of Chemicals (Vapors and Gases)

    E691-18 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

    E698-16 Standard Test Method for Kinetic Parameters for Thermally Unstable Materials Using Differential Scanning Calorimetry and the Flynn/Wall/Ozawa Method

    E793-06(2018) Standard Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry

    E794-06(2018) Standard Test Method for Melting And Crystallization Temperatures By Thermal Analysis

    E831-14 Standard Test Method for Linear Thermal Expansion of Solid Materials by Thermomechanical Analysis

    E918-83(2011) Standard Practice for Determining Limits of Flammability of Chemicals at Elevated Temperature and Pressure

    E928-08(2014) Standard Test Method for Purity by Differential Scanning Calorimetry

    E967-18 Standard Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal Analyzers

    E968-02(2014) Standard Practice for Heat Flow Calibration of Differential Scanning Calorimeters

    E1131-08(2014) Standard Test Method for Compositional Analysis by Thermogravimetry

    E1142-15 Standard Terminology Relating to Thermophysical Properties

    E1169-17e1 Standard Practice for Conducting Ruggedness Tests

    E1225-13 Standard Test Method for Thermal Conductivity of Solids Using the Guarded-Comparative-Longitudinal Heat Flow Technique

    E1226-12a Standard Test Method for Explosibility of Dust Clouds

    E1231-15 Standard Practice for Calculation of Hazard Potential Figures of Merit for Thermally Unstable Materials

    E1232-07(2013) Standard Test Method for Temperature Limit of Flammability of Chemicals

    E1269-11(2018) Standard Test Method for Determining Specific Heat Capacity by Differential Scanning Calorimetry

    E1323-15 Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data

    E1325-16 Standard Terminology Relating to Design of Experiments

    E1356-08(2014) Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry

    E1363-16 Standard Test Method for Temperature Calibration of Thermomechanical Analyzers

    E1402-13 Standard Guide for Sampling Design

    E1445-08(2015) Standard Terminology Relating to Hazard Potential of Chemicals

    E1461-13 Standard Test Method for Thermal Diffusivity by the Flash Method

    E1488-12(2018) Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods

    E1491-06(2012) Standard Test Method for Minimum Autoignition Temperature of Dust Clouds

    E1515-14 Standard Test Method for Minimum Explosible Concentration of Combustible Dusts

    E1530-11(2016) Standard Test Method for Evaluating the Resistance to Thermal Transmission of Materials by the Guarded Heat Flow Meter Technique

    E1545-11(2016) Standard Test Method for Assignment of the Glass Transition Temperature by Thermomechanical Analysis

    E1564-00(2014) Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials

    E1565-00(2014) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures

    E1566-00(2014) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

    E1582-17 Standard Test Method for Temperature Calibration of Thermogravimetric Analyzers

    E1640-13(2018) Standard Test Method for Assignment of the Glass Transition Temperature By Dynamic Mechanical Analysis

    E1641-16 Standard Test Method for Decomposition Kinetics by Thermogravimetry Using the Ozawa/Flynn/Wall Method

    E1719-12(2018) Standard Test Method for Vapor Pressure of Liquids by Ebulliometry

    E1782-14 Standard Test Method for Determining Vapor Pressure by Thermal Analysis

    E1824-13 Standard Test Method for Assignment of a Glass Transition Temperature Using Thermomechanical Analysis: Tension Method

    E1858-08(2015)e1 Standard Test Methods for Determining Oxidation Induction Time of Hydrocarbons by Differential Scanning Calorimetry

    E1860-13 Standard Test Method for Elapsed Time Calibration of Thermal Analyzers

    E1867-16 Standard Test Methods for Temperature Calibration of Dynamic Mechanical Analyzers

    E1868-10(2015) Standard Test Methods for Loss-On-Drying by Thermogravimetry

    E1877-17 Standard Practice for Calculating Thermal Endurance of Materials from Thermogravimetric Decomposition Data

    E1952-17 Standard Test Method for Thermal Conductivity and Thermal Diffusivity by Modulated Temperature Differential Scanning Calorimetry

    E1953-14 Standard Practice for Description of Thermal Analysis and Rheology Apparatus

    E1970-16 Standard Practice for Statistical Treatment of Thermoanalytical Data

    E1981-98(2012)e2 Standard Guide for Assessing Thermal Stability of Materials by Methods of Accelerating Rate Calorimetry

    E1994-09(2013) Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans

    E2008-17 Standard Test Methods for Volatility Rate by Thermogravimetry

    E2009-08(2014)e1 Standard Test Methods for Oxidation Onset Temperature of Hydrocarbons by Differential Scanning Calorimetry

    E2012-06(2012) Standard Guide for the Preparation of a Binary Chemical Compatibility Chart

    E2019-03(2013) Standard Test Method for Minimum Ignition Energy of a Dust Cloud in Air

    E2021-15 Standard Test Method for Hot-Surface Ignition Temperature of Dust Layers

    E2040-08(2014) Standard Test Method for Mass Scale Calibration of Thermogravimetric Analyzers

    E2041-13(2018) Standard Test Method for Estimating Kinetic Parameters by Differential Scanning Calorimeter Using the Borchardt and Daniels Method

    E2046-14 Standard Test Method for Reaction Induction Time by Thermal Analysis

    E2069-06(2018) Standard Test Method for Temperature Calibration on Cooling of Differential Scanning Calorimeters

    E2070-13(2018) Standard Test Methods for Kinetic Parameters by Differential Scanning Calorimetry Using Isothermal Methods

    E2071-00(2015) Standard Practice for Calculating Heat of Vaporization or Sublimation from Vapor Pressure Data

    E2079-07(2013) Standard Test Methods for Limiting Oxygen (Oxidant) Concentration in Gases and Vapors

    E2092-13 Standard Test Method for Distortion Temperature in Three-Point Bending by Thermomechanical Analysis

    E2097-00(2014) Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products

    E2113-13 Standard Test Method for Length Change Calibration of Thermomechanical Analyzers

    E2160-04(2018) Standard Test Method for Heat of Reaction of Thermally Reactive Materials by Differential Scanning Calorimetry

    E2161-15 Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology

    E2206-11(2015) Standard Test Method for Force Calibration of Thermomechanical Analyzers

    E2234-09(2013) Standard Practice for Sampling a Stream of Product by Attributes Indexed by AQL

    E2253-16 Standard Test Method for Temperature and Enthalpy Measurement Validation of Differential Scanning Calorimeters

    E2254-13 Standard Test Method for Storage Modulus Calibration of Dynamic Mechanical Analyzers

    E2281-15 Standard Practice for Process Capability and Performance Measurement

    E2282-14 Standard Guide for Defining the Test Result of a Test Method

    E2334-09(2013)e2 Standard Practice for Setting an Upper Confidence Bound For a Fraction or Number of Non-Conforming items, or a Rate of Occurrence for Non-conformities, Using Attribute Data, When There is a Zero Response in the Sample

    E2347-16 Standard Test Method for Indentation Softening Temperature by Thermomechanical Analysis

    E2363-14 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

    E2402-11(2017) Standard Test Method for Mass Loss and Residue Measurement Validation of Thermogravimetric Analyzers

    E2403-06(2018) Standard Test Method for Sulfated Ash of Organic Materials by Thermogravimetry

    E2425-16 Standard Test Method for Loss Modulus Conformance of Dynamic Mechanical Analyzers

    E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

    E2475-10(2016) Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

    E2476-16 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

    E2489-16 Standard Practice for Statistical Analysis of One-Sample and Two-Sample Interlaboratory Proficiency Testing Programs

    E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

    E2503-13e1 Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

    E2509-14 Standard Test Method for Temperature Calibration of Rheometers in Isothermal Mode

    E2510-07(2013) Standard Test Method for Torque Calibration or Conformance of Rheometers

    E2537-16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing

    E2550-17 Standard Test Method for Thermal Stability by Thermogravimetry

    E2551-13 Standard Test Method for Humidity Calibration (or Conformation) of Humidity Generators for Use with Thermogravimetric Analyzers

    E2554-18 Standard Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques

    E2555-07(2018) Standard Practice for Factors and Procedures for Applying the MIL-STD-105 Plans in Life and Reliability Inspection

    E2584-14 Standard Practice for Thermal Conductivity of Materials Using a Thermal Capacitance (Slug) Calorimeter

    E2585-09(2015) Standard Practice for Thermal Diffusivity by the Flash Method

    E2586-18 Standard Practice for Calculating and Using Basic Statistics

    E2587-16 Standard Practice for Use of Control Charts in Statistical Process Control

    E2602-09(2015) Standard Test Methods for the Assignment of the Glass Transition Temperature by Modulated Temperature Differential Scanning Calorimetry

    E2603-15 Standard Practice for Calibration of Fixed-Cell Differential Scanning Calorimeters

    E2629-11 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

    E2655-14 Standard Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement Uncertainty in ASTM Test Methods

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

    E2696-09(2013) Standard Practice for Life and Reliability Testing Based on the Exponential Distribution

    E2709-14e1 Standard Practice for Demonstrating Capability to Comply with an Acceptance Procedure

    E2716-09(2014) Standard Test Method for Determining Specific Heat Capacity by Sinusoidal Modulated Temperature Differential Scanning Calorimetry

    E2744-16e1 Standard Test Method for Pressure Calibration of Thermal Analyzers

    E2762-10(2014) Standard Practice for Sampling a Stream of Product by Variables Indexed by AQL

    E2769-16 Standard Test Method for Elastic Modulus by Thermomechanical Analysis Using Three-Point Bending and Controlled Rate of Loading

    E2781-16 Standard Practice for Evaluation of Methods for Determination of Kinetic Parameters by Calorimetry and Differential Scanning Calorimetry

    E2782-17 Standard Guide for Measurement Systems Analysis (MSA)

    E2810-11(2017) Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

    E2819-11(2015) Standard Practice for Single- and Multi-Level Continuous Sampling of a Stream of Product by Attributes Indexed by AQL

    E2888-12 Standard Practice for Process for Inactivation of Rodent Retrovirus by pH

    E2890-12(2018) Standard Test Method for Kinetic Parameters for Thermally Unstable Materials by Differential Scanning Calorimetry Using the Kissinger Method

    E2891-13 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

    E2898-14 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

    E2910-12(2018) Standard Guide for Preferred Methods for Acceptance of Product

    E2918-13 Standard Test Method for Performance Validation of Thermomechanical Analyzers

    E2931-13 Standard Test Method for Limiting Oxygen (Oxidant) Concentration of Combustible Dust Clouds

    E2935-17 Standard Practice for Conducting Equivalence Testing in Laboratory Applications

    E2958-14 Standard Test Methods for Kinetic Parameters by Factor Jump/Modulated Thermogravimetry

    E2968-14 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry

    E2975-16e1 Standard Test Method for Calibration or Calibration Verification of Concentric Cylinder Rotational Viscometers

    E3007-15 Standard Practice for Kinetic Values Used to Evaluate the Study of Decomposition Reactions by Thermogravimetry

    E3042-16 Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment

    E3051-16 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing

    E3060-16 Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy

    E3070-16 Standard Test Method for Shear Thinning Index on Non-Newtonian Liquids Using a Concentric Cylinder Rotational Viscometer

    E3077-17e1 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

    E3080-17 Standard Practice for Regression Analysis

    E3106-17 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

    E3116-18 Standard Test Method for Viscosity Measurement Validation of Rotational Viscometers

    E3142-18 Standard Test Method for Thermal Lag of Thermal Analysis Apparatus

    F838-15a Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

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    - 2018
       Standards: 148
       Pages: 1338

    - 2017
       Standards: 142
       Pages: 1302