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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
PUBLIKÁCIE vydaná dňa 1.1.2021
| Dostupnosť | Vypredané |
| Cena | NA OTÁZKU bez DPH |
| NA OTÁZKU |
Informácie o produkte:
Označenie: ASTM Volume 14.05 - Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical Products
Počet strán: 1548
Približná hmotnosť: 4675 g (10.31 libier)
Dátum vydania: 1.1.2021
Krajina: Americká publikácia
Anotácia 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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