Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: ASTM 14.05
• Năm ban hành / Publication date: 2020
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical and Biopharmaceutical Products
• Số trang / Page: 1

Phạm vi áp dụng / Scope of standard

Abstract:

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.