Stability Data Vs. USP 36

Controlled Room Temperature Storage Case Study

In our application notes and articles about environmental management in pharmaceutical, biotechnology, and medical device applications we usually stay at the level of principles because every scenario is different. Guidance documents are written broadly for just this reason: the needs of each product and the parameters of each environment will, more than all other factors, determine how you will apply regulations and guidance.

Having said that, along with providing monitoring and validation systems, we enjoy delving a little deeper into some of the issues that come up in the applications of our customers. Here is a situation that occurred around controlled room temperature and USP guidance.