Product sterility assurance changes

Changes that may affect product sterility assurance including, where appropriate, process changes for sterile drug substances and sterile packaging components. These include ... 

For sterile products, any other change that may affect product sterility assurance such as °... 

Lyophilized products are characterized by prolonged shelf-life, and chemical bacteria or enzymatic changes do not easily occur. The sterility is more guaranteed and solubility assured. In addition, transportation is easier. Finally, certain compounds or radiopharmaceutical kits exist only as lyophilized products. However, freeze-dried products suffer from certain disadvantages. The reentry of moisture may destroy the products. Direct optical control of lyophilized products cannot be performed. Therefore, the risk of particle contamination of the final product is high. Bacterial contamination can only be avoided by using the proper installations (clean rooms) for manufacturing injectable lyophilized products. 

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