Batch uniformity and consistent critical quality attributes are vital to lyophilization as a process for product preservation. To achieve these goals adequate process control and reproducibility must be ensured.
Shelf temperature mapping is a critical component of lyophilizer qualification. The previous articles in this series explored the methods used to record the shelf surface temperatures (Part I) and designing an appropriate study (Part II). Interpreting a shelf temperature mapping study’s result is as critical to assessing uniformity as the temperature measurement, the study design, and the...
Qualification of equipment used in the manufacturing of pharmaceutical products is a critical step in ensuring the production of a product that consistently meets all critical quality attributes. The US Food and Drug Administration (FDA) has stated a shelf temperature mapping, or a shelf temperature uniformity study is an expected step in the qualification of lyophilizers (freeze dryers).
Historically, the pharmaceutical industry’s focus has been on the lyophilization process and equipment, but discussion about calibration of process monitoring and control instrumentation has been quite limited. Recently, focused attention has been given to control and monitoring instrumentation for lyophilization.
