ASTM Volume 14.01, June 2024

Table of Contents

E2819-11(2021) Standard Practice for Single- and Multi-Level Continuous Sampling of a Stream of Product by Attributes Indexed by AQL

E2629-20 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

E177-20 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods

E1225-20 Standard Test Method for Thermal Conductivity of Solids Using the Guarded-Comparative-Longitudinal Heat Flow Technique

E2402-19 Standard Test Method for Mass Loss, Residue, and Temperature Measurement Validation of Thermogravimetric Analyzers

E2046-19 Standard Test Method for Reaction Induction Time by Thermal Analysis

E2069-19 Standard Test Method for Temperature Calibration on Cooling of Differential Scanning Calorimeters

E2206-21 Standard Test Method for Force Calibration of Thermomechanical Analyzers

E1877-21 Standard Practice for Calculating Thermal Endurance of Materials from Thermogravimetric Decomposition Data

E105-21 Standard Guide for Probability Sampling of Materials

E2935-21 Standard Practice for Evaluating Equivalence of Two Testing Processes

E3250-21 Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying

E2008-17(2021) Standard Test Methods for Volatility Rate by Thermogravimetry

E178-21 Standard Practice for Dealing With Outlying Observations

E2696-21 Standard Practice for Life and Reliability Testing Based on the Exponential Distribution

E3007-21 Standard Practice for Selection and Use of Kinetic Reference Values in the Study of Decomposition Reactions by Thermogravimetry

E2347-21 Standard Test Method for Indentation Softening Temperature by Thermomechanical Analysis

E1169-21 Standard Practice for Conducting Ruggedness Tests

E2253-21 Standard Test Method for Temperature and Enthalpy Measurement Validation of Differential Scanning Calorimeters

E1325-21 Standard Terminology Relating to Design of Experiments

E582-21 Standard Test Method for Minimum Ignition Energy and Quenching Distance in Gaseous Mixtures

E502-21a Standard Test Method for Selection and Use of ASTM Standards for the Determination of Flash Point of Chemicals by Closed Cup Methods

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

E1582-21 Standard Test Method for Temperature Calibration of Thermogravimetric Analyzers

E2587-16(2021)e1 Standard Practice for Use of Control Charts in Statistical Process Control

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

E3159-21 Standard Guide for General Reliability

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

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

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

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

E1824-19 Standard Test Method for Assignment of a Glass Transition Temperature Using Thermomechanical Analysis: Tension Method

E1131-20 Standard Test Method for Compositional Analysis by Thermogravimetry

E3177-18 Standard Guide on Sampling for Process Analytical Technology

E680-79(2018) Standard Test Method for Drop Weight Impact Sensitivity of Solid-Phase Hazardous Materials

E1491-06(2019) Standard Test Method for Minimum Autoignition Temperature of Dust Clouds

E1564-00(2019) Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials

E1566-00(2019) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

E1565-00(2019) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures

E2888-12(2019) Standard Practice for Process for Inactivation of Rodent Retrovirus by pH

E1530-19 Standard Test Method for Evaluating the Resistance to Thermal Transmission by the Guarded Heat Flow Meter Technique

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

E1232-07(2019) Standard Test Method for Temperature Limit of Flammability of Chemicals

E2931-13(2019) Standard Test Method for Limiting Oxygen (Oxidant) Concentration of Combustible Dust Clouds

E2019-03(2019) Standard Test Method for Minimum Ignition Energy of a Dust Cloud in Air

E831-19 Standard Test Method for Linear Thermal Expansion of Solid Materials by Thermomechanical Analysis

E928-19 Standard Test Method for Purity by Differential Scanning Calorimetry

E2079-19 Standard Test Methods for Limiting Oxygen (Oxidant) Concentration in Gases and Vapors

E3077-17e2 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

E3231-19 Standard Guide for Cell Culture Growth Assessment of Single-Use Material

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

E2040-19 Standard Test Method for Mass Scale Calibration of Thermogravimetric Analyzers

E918-19 Standard Practice for Determining Limits of Flammability of Chemicals at Elevated Temperature and Pressure

E1226-19 Standard Test Method for Explosibility of Dust Clouds

E537-20 Standard Test Method for Thermal Stability of Chemicals by Differential Scanning Calorimetry

E487-20 Standard Test Methods for Constant-Temperature Stability of Chemical Materials

E2503-13(2020) Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

E2012-06(2020) Standard Guide for the Preparation of a Binary Chemical Compatibility Chart

E2586-19e1 Standard Practice for Calculating and Using Basic Statistics

E1953-20 Standard Practice for Description of Thermal Analysis and Rheology Apparatus

E2551-20 Standard Test Methods for Humidity Calibration (or Conformation) of Humidity Generators for Use with Thermogravimetric Analyzers

E3230-20 Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing

E2762-10(2020) Standard Practice for Sampling a Stream of Product by Variables Indexed by AQL

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

E2554-18e1 Standard Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques

E2655-14(2020) Standard Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement Uncertainty in ASTM Test Methods

E2510-20 Standard Test Method for Torque Calibration or Conformance of Rheometers

E3219-20 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)

E2425-21 Standard Test Method for Loss Modulus Conformance of Dynamic Mechanical Analyzers

E2147-18 Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems

E1323-15(2020) Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data

E2281-15(2020) Standard Practice for Process Capability and Performance Measurement

E2891-20 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

E1231-19 Standard Practice for Calculation of Hazard Potential Figures of Merit for Thermally Unstable Materials

E2584-20 Standard Practice for Thermal Conductivity of Materials Using a Thermal Capacitance (Slug) Calorimeter

E2898-20a Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

F838-20 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

E1868-10(2021) Standard Test Methods for Loss-On-Drying by Thermogravimetry

E2550-21 Standard Test Method for Thermal Stability by Thermogravimetry

E2509-21 Standard Test Method for Temperature Calibration of Rheometers in Isothermal Mode

E2744-21 Standard Test Method for Pressure Calibration of Thermal Analyzers

E2958-21 Standard Test Methods for Kinetic Parameters by Factor Jump/Modulated Thermogravimetry

E2071-21 Standard Practice for Calculating Heat of Vaporization or Sublimation from Vapor Pressure Data

E2890-21 Standard Test Method for Determination of Kinetic Parameters and Reaction Order for Thermally Unstable Materials by Differential Scanning Calorimetry Using the Kissinger and Farjas Methods

E2489-21 Standard Practice for Statistical Analysis of One-Sample and Two-Sample Interlaboratory Proficiency Testing Programs

E3291-21 Standard Guide for Reliability Demonstration Testing

E2555-21e1 Standard Practice for Factors and Procedures for Applying the MIL-STD-105 Plans in Life and Reliability Inspection

E3264-21 Standard Guide for Homogeneity of Samples and Reference Materials Used for Inter- and Intra-Laboratory Studies

E3301-22 Standard Test Method for Temperature Calibration of Dynamic Mechanical Analyzers Using Thermal Lag

E3070-22e1 Standard Test Method for Shear Thinning Index of Non-Newtonian Liquids Using a Rotational Viscometer

E122-17(2022) Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process

E1461-13(2022) Standard Test Method for Thermal Diffusivity by the Flash Method

E29-22 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications

E1545-22 Standard Test Method for Assignment of the Glass Transition Temperature by Thermomechanical Analysis

E3336-22 Standard Test Method for Physical Integrity Testing of Single-Use Systems

E2602-22 Standard Test Methods for Assignment of the Glass Transition Temperature by Modulated Temperature Differential Scanning Calorimetry

E1515-14(2022) Standard Test Method for Minimum Explosible Concentration of Combustible Dusts

E2585-09(2022) Standard Practice for Thermal Diffusivity by the Flash Method

E2782-17(2022)e1 Standard Guide for Measurement Systems Analysis (MSA)

E3174-22 Standard Practice for Determination of Kinetic Reaction Model Using Differential Scanning Calorimetry

E1782-22 Standard Test Method for Determining Vapor Pressure by Thermal Analysis

E1981-22 Standard Guide for Assessing Thermal Stability of Materials by Methods of Accelerating Rate Calorimetry

E2769-22 Standard Test Method for Elastic Modulus by Thermomechanical Analysis Using Three-Point Bending and Controlled Rate of Loading

E1867-22 Standard Test Methods for Temperature Calibration of Dynamic Mechanical Analyzers

E3326-22 Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry

E3259-22 Standard Practice for Process to Remove Retroviruses by Small Virus Retentive Filters

E2476-22 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

E3106-22 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

E228-22 Standard Test Method for Linear Thermal Expansion of Solid Materials With a Push-Rod Dilatometer

E2975-23 Standard Test Method for Calibration or Calibration Verification of Concentric Cylinder Rotational Viscometers

E2009-23 Standard Test Methods for Oxidation Onset Temperature of Hydrocarbons by Differential Scanning Calorimetry

E2716-23 Standard Test Method for Determining Specific Heat Capacity by Modulated Temperature Differential Scanning Calorimetry

E3263-22e1 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

E1994-09(2023) Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans

E2234-09(2023) Standard Practice for Sampling a Stream of Product by Attributes Indexed by AQL

E2334-09(2023) 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

E2968-23 Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry

E1970-23 Standard Practice for Statistical Treatment of Thermoanalytical Data

E2363-23 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry

E3251-23 Standard Test Method for Microbial Ingress Testing on Single-Use Systems

E691-23 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

E1858-23 Standard Test Methods for Determining Oxidation Induction Time of Hydrocarbons by Differential Scanning Calorimetry

E659-15(2023) Standard Test Method for Autoignition Temperature of Chemicals

E681-09(2023) Standard Test Method for Concentration Limits of Flammability of Chemicals (Vapors and Gases)

E2021-15(2023) Standard Test Method for Hot-Surface Ignition Temperature of Dust Layers

E3116-23 Standard Test Method for Viscosity Measurement Validation of Rotational Viscometers

E1952-23 Standard Test Method for Thermal Conductivity and Thermal Diffusivity by Modulated Temperature Differential Scanning Calorimetry

E3142-18a(2023) Standard Test Method for Thermal Lag of Thermal Analysis Apparatus

E3244-23 Standard Practice for Integrity Assurance and Testing of Single-Use Systems

E2603-15(2023) Standard Practice for Calibration of Fixed-Cell Differential Scanning Calorimeters

E1356-23 Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry

E698-23 Standard Test Method for Kinetic Parameters for Thermally Unstable Materials Using Differential Scanning Calorimetry and the Flynn/Wall/Ozawa Method

E1363-23 Standard Test Method for Temperature Calibration of Thermomechanical Analyzers

E1640-23 Standard Test Method for Assignment of the Glass Transition Temperature By Dynamic Mechanical Analysis

E1641-23 Standard Test Method for Decomposition Kinetics by Thermogravimetry Using the Ozawa/Flynn/Wall Method

E1860-23 Standard Test Method for Elapsed Time Calibration of Thermal Analyzers

E2041-23 Standard Test Method for Estimating Kinetic Parameters by Differential Scanning Calorimeter Using the Borchardt and Daniels Method

E2918-23 Standard Test Method for Performance Validation of Thermomechanical Analyzers

E2113-23 Standard Test Method for Length Change Calibration of Thermomechanical Analyzers

E2161-23c Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology

E2403-23 Standard Test Method for Sulfated Ash of Organic Materials by Thermogravimetry

E473-23b Standard Terminology Relating to Thermal Analysis and Rheology

E1142-23b Standard Terminology Relating to Thermophysical Properties

E2070-23 Standard Test Methods for Kinetic Parameters by Differential Scanning Calorimetry Using Isothermal Methods

E3060-23 Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy

E3277-23a Standard Test Method for Determining the Liquid or Solid State of a Material by Rheometry

E2092-23 Standard Test Method for Distortion Temperature in Three-Point Bending by Thermomechanical Analysis

E2160-23 Standard Test Method for Heat of Reaction of Thermally Reactive Materials by Differential Scanning Calorimetry

E2709-23 Standard Practice for Demonstrating Capability to Comply with an Acceptance Procedure

E3418-23 Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices

E1402-13(2023) Standard Guide for Sampling Design

E3080-23 Standard Practice for Regression Analysis with a Single Predictor Variable

E141-10(2023) Standard Practice for Acceptance of Evidence Based on the Results of Probability Sampling

E1488-23 Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods

E2282-23 Standard Guide for Defining the Test Result of a Test Method

E2475-23 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

E1445-08(2023) Standard Terminology Relating to Hazard Potential of Chemicals

E2810-23 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

E3042-16(2024) Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment

E2254-24 Standard Test Method for Storage Modulus Calibration of Dynamic Mechanical Analyzers

E1719-24 Standard Test Method for Vapor Pressure of Liquids by Ebulliometry

E2781-24 Standard Practice for Evaluation of Methods for Determination of Kinetic Parameters by Calorimetry and Differential Scanning Calorimetry

E456-13a(2022)e1 Standard Terminology Relating to Quality and Statistics