Publikace  ASTM Volume 14.05 - Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical Products 1.1.2021 náhled

ASTM Volume 14.05 - Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical Products

ASTM Volume 14.05 - Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical Products

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PUBLIKACE vydána dne 1.1.2021


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Označení: ASTM Volume 14.05 - Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical Products
Počet stran: 1548
Přibližná hmotnost: 4675 g (10.31 liber)
Datum vydání: 1.1.2021
Země: Americká publikace

Anotace textu normy :

Standards cover:



Single-use systems



Hazard Potential of Chemicals—covers flash point, thermal stability and instability, explosibility, and autoignition temperatures of chemicals.



Quality and Statistics—practices and guides evaluate statistical methods, sampling and data analysis, and quality statements.



Thermal Measurements—practices and test methods cover thermal analysis and thermophysical properties.



Manufacture of Pharmaceutical and Biopharmaceutical Products—covers the application of process analytical technology (PAT) within the pharmaceutical and biopharmaceutical industry, highlighting PAT system management, implementation, and practices. Also includes standards on cleaning process validation per ASTM E3106.


Table of Contents



E29-13(2019)   Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E105-21   Standard Guide 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
E177-20   Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E178-21   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)e5   Standard Terminology Relating to Quality and Statistics
E473-21   Standard Terminology Relating to Thermal Analysis and Rheology
E487-20   Standard Test Methods for Constant-Temperature Stability of Chemical Materials
E502-21a   Standard Test Method for Selection and Use of ASTM Standards for the Determination of Flash Point of Chemicals by Closed Cup Methods
E537-20   Standard Test Method for Thermal Stability of Chemicals by Differential Scanning Calorimetry
E582-21   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(2018)   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)
E691-20   Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E698-18   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
E831-19   Standard Test Method for Linear Thermal Expansion of Solid Materials by Thermomechanical Analysis
E918-19   Standard Practice for Determining Limits of Flammability of Chemicals at Elevated Temperature and Pressure
E928-19   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
E1131-20   Standard Test Method for Compositional Analysis by Thermogravimetry
E1142-21   Standard Terminology Relating to Thermophysical Properties
E1169-21   Standard Practice for Conducting Ruggedness Tests
E1225-20   Standard Test Method for Thermal Conductivity of Solids Using the Guarded-Comparative-Longitudinal Heat Flow Technique
E1226-19   Standard Test Method for Explosibility of Dust Clouds
E1231-19   Standard Practice for Calculation of Hazard Potential Figures of Merit for Thermally Unstable Materials
E1232-07(2019)   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(2020)   Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data
E1325-21   Standard Terminology Relating to Design of Experiments
E1356-08(2014)   Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
E1363-18   Standard Test Method for Temperature Calibration of Thermomechanical Analyzers
E1402-13(2018)   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(2019)   Standard Test Method for Minimum Autoignition Temperature of Dust Clouds
E1515-14   Standard Test Method for Minimum Explosible Concentration of Combustible Dusts
E1530-19   Standard Test Method for Evaluating the Resistance to Thermal Transmission 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(2019)   Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
E1565-00(2019)   Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
E1566-00(2019)   Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
E1582-21   Standard Test Method for Temperature Calibration of Thermogravimetric Analyzers
E1640-18   Standard Test Method for Assignment of the Glass Transition Temperature By Dynamic Mechanical Analysis
E1641-18   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
E1824-19   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(2018)   Standard Test Method for Elapsed Time Calibration of Thermal Analyzers
E1867-18   Standard Test Methods for Temperature Calibration of Dynamic Mechanical Analyzers
E1868-10(2021)   Standard Test Methods for Loss-On-Drying by Thermogravimetry
E1877-21   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
E1953-20   Standard Practice for Description of Thermal Analysis and Rheology Apparatus
E1970-16   Standard Practice for Statistical Treatment of Thermoanalytical Data
E1981-98(2020)   Standard Guide for Assessing Thermal Stability of Materials by Methods of Accelerating Rate Calorimetry
E1994-09(2018)   Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
E2008-17(2021)   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(2020)   Standard Guide for the Preparation of a Binary Chemical Compatibility Chart
E2019-03(2019)   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
E2040-19   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
E2046-19   Standard Test Method for Reaction Induction Time by Thermal Analysis
E2069-19   Standard Test Method for Temperature Calibration on Cooling of Differential Scanning Calorimeters
E2070-13(2018)   Standard Test Methods for Kinetic Parameters by Differential Scanning Calorimetry Using Isothermal Methods
E2071-21   Standard Practice for Calculating Heat of Vaporization or Sublimation from Vapor Pressure Data
E2079-19   Standard Test Methods for Limiting Oxygen (Oxidant) Concentration in Gases and Vapors
E2092-18a   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
E2113-18   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
E2161-21b   Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
E2206-21   Standard Test Method for Force Calibration of Thermomechanical Analyzers
E2234-09(2018)   Standard Practice for Sampling a Stream of Product by Attributes Indexed by AQL
E2253-21   Standard Test Method for Temperature and Enthalpy Measurement Validation of Differential Scanning Calorimeters
E2254-18   Standard Test Method for Storage Modulus Calibration of Dynamic Mechanical Analyzers
E2281-15(2020)   Standard Practice for Process Capability and Performance Measurement
E2282-14(2019)   Standard Guide for Defining the Test Result of a Test Method
E2334-09(2018)   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
E2347-21   Standard Test Method for Indentation Softening Temperature by Thermomechanical Analysis
E2363-14   Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
E2402-19   Standard Test Method for Mass Loss, Residue, and Temperature 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
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
E2500-20   Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
E2503-13(2020)   Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
E2509-14   Standard Test Method for Temperature Calibration of Rheometers in Isothermal Mode
E2510-20   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
E2551-20   Standard Test Methods for Humidity Calibration (or Conformation) of Humidity Generators for Use with Thermogravimetric Analyzers
E2554-18e1   Standard Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques
E2555-21   Standard Practice for Factors and Procedures for Applying the MIL-STD-105 Plans in Life and Reliability Inspection
E2584-20   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
E2586-19e1   Standard Practice for Calculating and Using Basic Statistics
E2587-16(2021)e1   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
E2629-20   Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
E2655-14(2020)   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
E2696-21   Standard Practice for Life and Reliability Testing Based on the Exponential Distribution
E2709-19   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(2020)   Standard Practice for Sampling a Stream of Product by Variables Indexed by AQL
E2769-18   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)
E2810-19   Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
E2819-11(2021)   Standard Practice for Single- and Multi-Level Continuous Sampling of a Stream of Product by Attributes Indexed by AQL
E2888-12(2019)   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
E2891-20   Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
E2898-20a   Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
E2910-12(2018)   Standard Guide for Preferred Methods for Acceptance of Product
E2918-18a   Standard Test Method for Performance Validation of Thermomechanical Analyzers
E2931-13(2019)   Standard Test Method for Limiting Oxygen (Oxidant) Concentration of Combustible Dust Clouds
E2935-21   Standard Practice for Evaluating Equivalence of Two Testing Processes
E2958-19   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
E3007-21   Standard Practice for Selection and Use of Kinetic Reference Values in 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
E3070-18   Standard Test Method for Shear Thinning Index of Non-Newtonian Liquids Using a Rotational Viscometer
E3077-17e2   Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
E3080-19   Standard Practice for Regression Analysis with a Single Predictor Variable
E3106-18e1   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
E3142-18a   Standard Test Method for Thermal Lag of Thermal Analysis Apparatus
E3159-21   Standard Guide for General Reliability
E3174-21   Standard Practice for Determination of Kinetic Reaction Model Using Differential Scanning Calorimetry
E3177-18   Standard Guide on Sampling for Process Analytical Technology
E3219-20   Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
E3230-20   Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing
E3231-19   Standard Guide for Cell Culture Growth Assessment of Single-Use Material
E3244-20   Standard Practice for Integrity Assurance and Testing of Single-Use Systems
E3250-21   Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying
E3251-20   Standard Test Method for Microbial Ingress Testing on Single-Use Systems
E3263-20   Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
E3277-21   Standard Test Method for Determining Whether a Material is a Liquid or a Solid by Rheometry
F838-20   Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

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