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Lyophilizer Cleaning Validation: Why Perform Cleaning Validation?

The lyophilized drugs in the pharmaceutical industry cannot afford to compromise on cleanliness. Lyophilizer contamination results in wasted effort and resources, or worse, creates health and safety issues that can compromise a company’s reputation and customer confidence. Detecting and quantifying trace residue concentrations of active pharmaceutical ingredients (API), excipients, and washes during lyophilizer cleaning validation procedures is one of the single largest costs associated with the manufacture of pharmaceutical freeze dried drugs. The lyophilizer cleaning validation is a very laborious process and combined with the idle time of the manufacturing equipment is a very expensive pa

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