Hageman T C
Biogen Inc., Cambridge Center, MA 02142.
Dev Biol Stand. 1992;76:231-7.
A model for validation of viral clearances in Biopharmaceutical processes is developed from an analysis of validation of terminal sterilization processes. The model develops the role for small-scale experiments in the validation of large-scale production processes. The steps for process validation are: identify or discover the basic general physical, chemical, or biological laws governing the process; identify the critical process control parameters for the specific application under investigation; and demonstrate the ability of the production equipment to maintain critical parameters with specified limits. For concurrent validation, this final step is seen as equivalent to demonstrating that a scaled-down model experiment is an appropriate representation of the production process.
通过对最终灭菌工艺验证的分析，开发了一种用于生物制药过程中病毒清除验证的模型。该模型确定了小规模实验在大规模生产工艺验证中的作用。工艺验证的步骤如下：识别或发现支配该工艺的基本通用物理、化学或生物学规律；确定所研究特定应用的关键工艺控制参数；证明生产设备能够在规定限度内维持关键参数。对于同步验证，这最后一步被视为等同于证明缩小规模的模型实验是生产过程的恰当代表。
