ASTM Volume 14.

05, July 2019

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

Standard Number Title

Standard Practice for Using Significant Digits in Test Data to Determine Conformance with
1 E29-13(2019)
Specifications
2 E105-16 Standard Practice for Probability Sampling of Materials
Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the
3 E122-17
Average for a Characteristic of a Lot or Process
4 E141-10(2018) Standard Practice for Acceptance of Evidence Based on the Results of Probability Sampling
5 E177-14 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
6 E178-16a Standard Practice for Dealing With Outlying Observations
Standard Test Method for Linear Thermal Expansion of Solid Materials With a Push-Rod
7 E228-17
Dilatometer
8 E289-17 Standard Test Method for Linear Thermal Expansion of Rigid Solids with Interferometry
9 E456-13A(2017)e3 Standard Terminology Relating to Quality and Statistics
10 E473-18 Standard Terminology Relating to Thermal Analysis and Rheology
11 E487-14 Standard Test Method for Constant-Temperature Stability of Chemical Materials
Standard Test Method for Selection and Use of ASTM Standards for the Determination of Flash
12 E502-07(2013)
Point of Chemicals by Closed Cup Methods
Standard Test Method for The Thermal Stability of Chemicals by Differential Scanning
13 E537-12
Calorimetry
Standard Test Method for Minimum Ignition Energy and Quenching Distance in Gaseous
14 E582-07(2013)e1
Mixtures
15 E659-15 Standard Test Method for Autoignition Temperature of Chemicals
16 E680-79(2018) Standard Test Method for Drop Weight Impact Sensitivity of Solid-Phase Hazardous Materials
Standard Test Method for Concentration Limits of Flammability of Chemicals (Vapors and
17 E681-09(2015)
Gases)
Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test
18 E691-18
Method
Standard Test Method for Kinetic Parameters for Thermally Unstable Materials Using Differential
19 E698-18
Scanning Calorimetry and the Flynn/Wall/Ozawa Method
Standard Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning
20 E793-06(2018)
Calorimetry
21 E794-06(2018) Standard Test Method for Melting And Crystallization Temperatures By Thermal Analysis
Standard Test Method for Linear Thermal Expansion of Solid Materials by Thermomechanical
22 E831-19
Analysis
Standard Practice for Determining Limits of Flammability of Chemicals at Elevated Temperature
23 E918-83(2011)
and Pressure
24 E928-19 Standard Test Method for Purity by Differential Scanning Calorimetry
Standard Test Method for Temperature Calibration of Differential Scanning Calorimeters and
25 E967-18
Differential Thermal Analyzers
26 E968-02(2014) Standard Practice for Heat Flow Calibration of Differential Scanning Calorimeters
27 E1131-08(2014) Standard Test Method for Compositional Analysis by Thermogravimetry
28 E1142-15 Standard Terminology Relating to Thermophysical Properties
29 E1169-18 Standard Practice for Conducting Ruggedness Tests
Standard Test Method for Thermal Conductivity of Solids Using the Guarded-Comparative-
30 E1225-13
Longitudinal Heat Flow Technique
31 E1226-12a Standard Test Method for Explosibility of Dust Clouds
Standard Practice for Calculation of Hazard Potential Figures of Merit for Thermally Unstable
32 E1231-15
Materials
33 E1232-07(2019) Standard Test Method for Temperature Limit of Flammability of Chemicals
Standard Test Method for Determining Specific Heat Capacity by Differential Scanning
34 E1269-11(2018)
Calorimetry
Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of
35 E1323-15
the Resulting Data
36 E1325-16 Standard Terminology Relating to Design of Experiments
Standard Test Method for Assignment of the Glass Transition Temperatures by Differential
37 E1356-08(2014)
Scanning Calorimetry
38 E1363-18 Standard Test Method for Temperature Calibration of Thermomechanical Analyzers
39 E1402-13(2018) Standard Guide for Sampling Design
40 E1445-08(2015) Standard Terminology Relating to Hazard Potential of Chemicals

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 ASTM Volume 14.05, July 2019
Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of
Pharmaceutical and Biopharmaceutical Products
Table of Contents

Standard Number Title

41 E1461-13 Standard Test Method for Thermal Diffusivity by the Flash Method
42 E1488-12(2018) Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
43 E1491-06(2019) Standard Test Method for Minimum Autoignition Temperature of Dust Clouds
44 E1515-14 Standard Test Method for Minimum Explosible Concentration of Combustible Dusts
Standard Test Method for Evaluating the Resistance to Thermal Transmission by the Guarded
45 E1530-19
Heat Flow Meter Technique
Standard Test Method for Assignment of the Glass Transition Temperature by
46 E1545-11(2016)
Thermomechanical Analysis
Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for
47 E1564-00(2019)
Maintaining Cryopreserved Biological Materials
Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low
48 E1565-00(2019)
Temperatures
49 E1566-00(2019) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
50 E1582-17 Standard Test Method for Temperature Calibration of Thermogravimetric Analyzers
Standard Test Method for Assignment of the Glass Transition Temperature By Dynamic
51 E1640-18
Mechanical Analysis
Standard Test Method for Decomposition Kinetics by Thermogravimetry Using the
52 E1641-18
Ozawa/Flynn/Wall Method
53 E1719-12(2018) Standard Test Method for Vapor Pressure of Liquids by Ebulliometry
54 E1782-14 Standard Test Method for Determining Vapor Pressure by Thermal Analysis
Standard Test Method for Assignment of a Glass Transition Temperature Using
55 E1824-18
Thermomechanical Analysis: Tension Method
Standard Test Methods for Determining Oxidation Induction Time of Hydrocarbons by Differential
56 E1858-08(2015)e1
Scanning Calorimetry
57 E1860-13(2018) Standard Test Method for Elapsed Time Calibration of Thermal Analyzers
58 E1867-18 Standard Test Methods for Temperature Calibration of Dynamic Mechanical Analyzers
59 E1868-10(2015) Standard Test Methods for Loss-On-Drying by Thermogravimetry
Standard Practice for Calculating Thermal Endurance of Materials from Thermogravimetric
60 E1877-17
Decomposition Data
Standard Test Method for Thermal Conductivity and Thermal Diffusivity by Modulated
61 E1952-17
Temperature Differential Scanning Calorimetry
62 E1953-14 Standard Practice for Description of Thermal Analysis and Rheology Apparatus
63 E1970-16 Standard Practice for Statistical Treatment of Thermoanalytical Data
Standard Guide for Assessing Thermal Stability of Materials by Methods of Accelerating Rate
64 E1981-98(2012)e2
Calorimetry
65 E1994-09(2018) Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
66 E2008-17 Standard Test Methods for Volatility Rate by Thermogravimetry
Standard Test Methods for Oxidation Onset Temperature of Hydrocarbons by Differential
67 E2009-08(2014)e1
Scanning Calorimetry
68 E2012-06(2012) Standard Guide for the Preparation of a Binary Chemical Compatibility Chart
69 E2019-03(2019) Standard Test Method for Minimum Ignition Energy of a Dust Cloud in Air
70 E2021-15 Standard Test Method for Hot-Surface Ignition Temperature of Dust Layers
71 E2040-08(2014) Standard Test Method for Mass Scale Calibration of Thermogravimetric Analyzers
Standard Test Method for Estimating Kinetic Parameters by Differential Scanning Calorimeter
72 E2041-13(2018)
Using the Borchardt and Daniels Method
73 E2046-14 Standard Test Method for Reaction Induction Time by Thermal Analysis
Standard Test Method for Temperature Calibration on Cooling of Differential Scanning
74 E2069-06(2018)
Calorimeters
Standard Test Methods for Kinetic Parameters by Differential Scanning Calorimetry Using
75 E2070-13(2018)
Isothermal Methods
76 E2071-00(2015) Standard Practice for Calculating Heat of Vaporization or Sublimation from Vapor Pressure Data
77 E2079-07(2013) Standard Test Methods for Limiting Oxygen (Oxidant) Concentration in Gases and Vapors
Standard Test Method for Distortion Temperature in Three-Point Bending by Thermomechanical
78 E2092-18a
Analysis
Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the
79 E2097-00(2014)
Safety of Biotechnology Products
80 E2113-18 Standard Test Method for Length Change Calibration of Thermomechanical Analyzers
Standard Test Method for Heat of Reaction of Thermally Reactive Materials by Differential
81 E2160-04(2018)
Scanning Calorimetry

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 ASTM Volume 14.05, July 2019
Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of
Pharmaceutical and Biopharmaceutical Products
Table of Contents

Standard Number Title

82 E2161-15 Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
83 E2206-11(2015) Standard Test Method for Force Calibration of Thermomechanical Analyzers
84 E2234-09(2018) Standard Practice for Sampling a Stream of Product by Attributes Indexed by AQL
Standard Test Method for Temperature and Enthalpy Measurement Validation of Differential
85 E2253-16
Scanning Calorimeters
86 E2254-18 Standard Test Method for Storage Modulus Calibration of Dynamic Mechanical Analyzers
87 E2281-15 Standard Practice for Process Capability and Performance Measurement
88 E2282-14(2019) Standard Guide for Defining the Test Result of a Test Method
Standard Practice for Setting an Upper Confidence Bound for a Fraction or Number of Non-
89 E2334-09(2018) Conforming items, or a Rate of Occurrence for Non-Conformities, Using Attribute Data, When
There is a Zero Response in the Sample
90 E2347-16 Standard Test Method for Indentation Softening Temperature by Thermomechanical Analysis
91 E2363-14 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
Standard Test Method for Mass Loss and Residue Measurement Validation of
92 E2402-11(2017)
Thermogravimetric Analyzers
93 E2403-06(2018) Standard Test Method for Sulfated Ash of Organic Materials by Thermogravimetry
94 E2425-16 Standard Test Method for Loss Modulus Conformance of Dynamic Mechanical Analyzers
95 E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
96 E2475-10(2016) Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development,
97 E2476-16
and Operation of PAT Processes for Pharmaceutical Manufacture
Standard Practice for Statistical Analysis of One-Sample and Two-Sample Interlaboratory
98 E2489-16
Proficiency Testing Programs
Standard Guide for Specification, Design, and Verification of Pharmaceutical and
99 E2500-13
Biopharmaceutical Manufacturing Systems and Equipment
100 E2503-13e1 Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
101 E2509-14 Standard Test Method for Temperature Calibration of Rheometers in Isothermal Mode
102 E2510-07(2013) Standard Test Method for Torque Calibration or Conformance of Rheometers
Standard Guide for Application of Continuous Process Verification to Pharmaceutical and
103 E2537-16
Biopharmaceutical Manufacturing
104 E2550-17 Standard Test Method for Thermal Stability by Thermogravimetry
Standard Test Methods for Humidity Calibration (or Conformation) of Humidity Generators for
105 E2551-18
Use with Thermogravimetric Analyzers
Standard Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method
106 E2554-18
Using Control Chart Techniques
Standard Practice for Factors and Procedures for Applying the MIL-STD-105 Plans in Life and
107 E2555-07(2018)e1
Reliability Inspection
Standard Practice for Thermal Conductivity of Materials Using a Thermal Capacitance (Slug)
108 E2584-14
Calorimeter
109 E2585-09(2015) Standard Practice for Thermal Diffusivity by the Flash Method
110 E2586-19 Standard Practice for Calculating and Using Basic Statistics
111 E2587-16 Standard Practice for Use of Control Charts in Statistical Process Control
Standard Test Methods for the Assignment of the Glass Transition Temperature by Modulated
112 E2602-09(2015)
Temperature Differential Scanning Calorimetry
113 E2603-15 Standard Practice for Calibration of Fixed-Cell Differential Scanning Calorimeters
Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control
114 E2629-11
Systems
Standard Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement
115 E2655-14
Uncertainty in ASTM Test Methods
Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic
116 E2656-16
Carbon Attribute
117 E2696-09(2018) Standard Practice for Life and Reliability Testing Based on the Exponential Distribution
118 E2709-19 Standard Practice for Demonstrating Capability to Comply with an Acceptance Procedure
Standard Test Method for Determining Specific Heat Capacity by Sinusoidal Modulated
119 E2716-09(2014)
Temperature Differential Scanning Calorimetry
120 E2744-16e1 Standard Test Method for Pressure Calibration of Thermal Analyzers
121 E2762-10(2014) Standard Practice for Sampling a Stream of Product by Variables Indexed by AQL
Standard Test Method for Elastic Modulus by Thermomechanical Analysis Using Three-Point
122 E2769-18
Bending and Controlled Rate of Loading

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 ASTM Volume 14.05, July 2019
Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of
Pharmaceutical and Biopharmaceutical Products
Table of Contents

Standard Number Title

Standard Practice for Evaluation of Methods for Determination of Kinetic Parameters by

123 E2781-16
Calorimetry and Differential Scanning Calorimetry
124 E2782-17 Standard Guide for Measurement Systems Analysis (MSA)
Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage
125 E2810-11(2017)
Units
Standard Practice for Single- and Multi-Level Continuous Sampling of a Stream of Product by
126 E2819-11(2015)
Attributes Indexed by AQL
127 E2888-12(2019) Standard Practice for Process for Inactivation of Rodent Retrovirus by pH
Standard Test Method for Kinetic Parameters for Thermally Unstable Materials by Differential
128 E2890-12(2018)
Scanning Calorimetry Using the Kissinger Method
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and
129 E2891-13
Manufacturing Applications
130 E2898-14 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
131 E2910-12(2018) Standard Guide for Preferred Methods for Acceptance of Product
132 E2918-18a Standard Test Method for Performance Validation of Thermomechanical Analyzers
133 E2931-13(2019) Standard Test Method for Limiting Oxygen (Oxidant) Concentration of Combustible Dust Clouds
134 E2935-17 Standard Practice for Conducting Equivalence Testing in Laboratory Applications
135 E2958-14 Standard Test Methods for Kinetic Parameters by Factor Jump/Modulated Thermogravimetry
136 E2968-14 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry
Standard Test Method for Calibration or Calibration Verification of Concentric Cylinder Rotational
137 E2975-16e1
Viscometers
Standard Practice for Kinetic Values Used to Evaluate the Study of Decomposition Reactions by
138 E3007-15
Thermogravimetry
139 E3042-16 Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment
Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in
140 E3051-16
Pharmaceutical and Biopharmaceutical Manufacturing
Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using
141 E3060-16
Dynamic (Flow) Imaging Microscopy
Standard Test Method for Shear Thinning Index of Non-Newtonian Liquids Using a Rotational
142 E3070-18
Viscometer
Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical &
143 E3077-17e1
Biopharmaceutical Manufacturers
144 E3080-17 Standard Practice for Regression Analysis
Standard Guide for Science-Based and Risk-Based Cleaning Process Development and
145 E3106-18e1
Validation
146 E3116-18 Standard Test Method for Viscosity Measurement Validation of Rotational Viscometers
147 E3142-18a Standard Test Method for Thermal Lag of Thermal Analysis Apparatus
148 E3159-18 Standard Guide for General Reliability
Standard Practice for Determination of Kinetic Reaction Model Using Differential Scanning
149 E3174-19
Calorimetry
150 E3177-18 Standard Guide on Sampling for Process Analytical Technology
Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid
151 F838-15ae1
Filtration

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