Micro Article - June 2019

How to Calculate Residue Limits for Cleaning Agents

Cleaning Agents are frequently used in a drug manufacturing environment to effectively remove the residue of previously manufactured products to get the production equipment ready for manufacturing the next drugs. Using Cleaning Agents becomes necessary when water is not considered a suitable agent.

Even though using Cleaning Agents is a common scenario in every drug manufacturing site, we have observed variances in the approach to establish residue limits of these. Primary points of debate are establishing the basis of toxicity and quantifying the interactions with other drug products within shared equipment.

In this Micro Article, we will put all these confusions to rest.

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