Sterile
Methods of Sterilization and Depyrogenation
Methods of Sterilization Heat Sterilization This method involves the use of high temperatures to kill microorganisms. It can be achieved through: Radiation Sterilization This method uses ionizing radiation, such as gamma rays or electron beams, to destroy microorganisms. It is commonly used for sterilizing medical equipment, pharmaceutical products, and certain ... Read More
Major Sources of Contamination in the Sterile Area
Contamination in the sterile area is a critical concern in a variety of industries. Understanding the sources of contamination is crucial in implementing effective measures to prevent and control it. The primary sources include human factors, air pollutants, equipment and materials, water and liquids, and cross-contamination. Human error is a ... Read More
Difference Between Extractables and Leachables
In the intricate world of biopharmaceutical manufacturing, the presence of extractables and leachables poses a significant challenge, potentially tarnishing the purity of invaluable drug products. The FDA offers precise definitions for these two critical terms: Extractables These are compounds that can be meticulously drawn out from the container closure system ... Read More