Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.
Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
The two main MFI test standards are ASTM D1238 - “Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer” and ISO1133 – “Determination of the Melt Mass-Flow Rate (MFR) and ...
The most probable number (MPN) bioburden test method can be a valuable tool for determining bioburden counts when the typical bioburden test methods are problematic on a particular product or when a ...
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