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ASTM 14.05

2018 Edition, July 2018

Complete Document

STATISTICAL METHODS; HAZARD POTENTIAL OF CHEMICALS; THERMAL MEASUREMENTS; MANUFACTURE OF PHARMACEUTICAL AND BIOPHARMACEUTICAL PRODUCTS



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Product Details:

  • Revision: 2018 Edition, July 2018
  • Published Date: July 2018
  • Status: Historical
  • Document Language:
  • Published By: ASTM International (ASTM)
  • Page Count: 0
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

Standards cover:

Single-use systems - Guide for specification, design, verification, and application of 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.