Transcription of Validation Guide Sartopore® 2 Cartridges ... - …
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Validation Guide Sartopore® 2 Cartridges ... - …
Validation Guide Sartopore 2 Cartridges , MaxiCaps , MidiCaps and Capsules| 3 1. Introduction cGMP Quality Assurance from sartorius Quality Assurance Prevention of Contamination Complete Traceability sartorius Drug Master File DMF 5967 Quality Management System 62. Technical Specifications Type and Part Number Overview Standard Cartridges Mini Cartridges MaxiCaps MidiCaps Capsules 150|300 Filter Material Mechanism of Filtration Pore Size Combinations Materials of Construction Fiber Release Test Methods for the Quality Assurance of sartorius Sartopore 2 Filter Cartridges and Capsules Dimensions Standard Cartridges Mini Cartridges MaxiCaps Total Height MidiCaps Capsules 150|300 Cartridges MaxiCaps MidiCaps Capsules 150|300 Maximum Back Pressure for Cartridges , MaxiCaps.
| 3 1. Introduction 5 1.1 cGMP Quality Assurance from Sartorius 6 1.2 2Quality Assurance 6 1.3 Prevention of Contamination 6 1.4 Complete Traceability 6
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