Vial size considerations for analysis
ASEPTIC PROCESS SIMULATION (MEDIA FILL) – PDA
production batch size. For production batches 5,000 to 10,000 units, the APS batch should be comparable size (5,000-10,000 units). For production batches >10,000 units, the APS batch should be > 10,000 units with several approaches to the batch size and filling process.
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