Validation of Bacterial Endotoxins Testing Platforms

摘要

Validation. This one word can invoke a series of feelings in any lab. It might invoke a feeling of fear or uneasiness because the process can be time-consuming and overwhelming. Or it can invoke a feeling of excitement because there is a new instrument coming into the lab. Whatever the feeling is, validating a new platform can be a daunting task.There are several guidelines, principles, and documentation that must be completed and followed precisely to ensure a successful validation. Instrument qualification is a frequently cited deviation in regulatory audits, making the potential of warning letters even more intimidating while going through the validation process. If the deviation is critical enough, it could shut down production, turning into a costly and timely error.