Search results for " traceability" in Articles / App Notes
Article
Reconciling Sensor Communication Gaps
PAT data, models, traditional process sensor data, material traceability, and tracking of single-use consumables all funnel into this data stream. Ensuring operational success requires integrated cont…
Article
Managing Risk in Raw Material Sourcing
“Plant-of-origin information and transparency regarding the source of raw materials is essential for traceability,” he says.
Avantor has globalized and standardized quality systems at its faciliti…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
• Maintain solid knowledge of raw materials origin, sourcing, manufacturing, testing, storage, and traceability.
• Review of critical raw material specifications for adequacy and viral saf…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Sinclair says the issue of batch identity is up to the user to define prior to manufacture and that “the real regulatory issue is one of traceability when there is a problem that has consequences of a…
Article
Trends in Single-use Bioreactors
Establishing full traceability of raw materials, robust process controls, and meaningful specifications from the polymer resin to the finished bag is crucial. Another issue is related to high cell den…
Article
High-Throughput Process Development in an Historical Environment
Since the introduction of HTPD approaches, it has been a challenge with the generation of large data sets, and also the visualization and traceability of analytical results. As part of a strategic ini…