Process Analytical Technologies are enablers for the Pharma 4.0 production. With the implementation of in-process-controls, process capabilities become transparent and allow quality improvements, higher efficiencies and a reduction of manufacturing costs.
Media-Fill Inspection
Recent developments in regulatory standards, particularly the revisions introduced in Annex 1 of the EU Good Manufacturing Practice (GMP), have significantly impacted aseptic filling practices. The revised annex contains new requirements to ensure the quality and safety of sterile medicinal products. These changes necessitate a more rigorous approach, leading to additional and more extensive tests.
Learn how Aseptic Process Simulation (APS) / Media Fill test can be automated with our solutions.
Headspace Analysis as in-process control
Besides leak testing, non-destructive Headspace Analysis (HSA) is used for applications such as Process Analytical Technology (PAT).
Water Activity Determination with NIRS
NIRS not only enables rapid and non-destructive water activity determination but also offers additional benefits, such as simultaneous material composition analysis and moisture quantification.
Near Infrared Spectroscopy (NIRS)
Near Infrared Spectroscopy (NIRS) is an economic and cost effective method of analysis. It is used for the identification or quantity analysis of lyophilizates, powders, granules, etc. The NIRS covers a very wide range of applications in pharmaceutical, food and beverage industry. NIR measurements can be performed off-line, or at-line, or in-line for process analytical technology (PAT).
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