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Instrumentation for Thermal Characterization and drug potency analysis
The first step for recipe optimization is thermally characterizing the product (Active Pharmaceutical Ingredient together with the excipients). Differential Scanning Calorimetry (DSC) for the glass transition temperature and/or the Eutectic point. Cryogenic microscopy for the collapse temperature.
Then also it is required the evaluate the efficacy of the process and evaluate the drug potency before and after the lyophilization: Stability, residual Humidity by Karl Fisher, PH, gases chromatographpy, flow cytometry, protein analysis and mesenchymal growth.
Custom made freeze drying modelization tools
Freeze drying cycles lasts between one and three days (sometimes even more). Complementary to experimental trials is crucial to thermodynamically simulate the process.
Primary drying simulation tool: full information of tempererature profile during the primary drying. Customizable including: trays with vials, protective membranes; time and filling height optimization.
Freezing step simulator: ramp rates at the product with precooled shelves, freezing times including phase change.
It can be integrated to production optimization tools.
Pilot plant freeze dryer in class C laboratory
Fully equiped 1m2 pilot freeze dryer (batch 4.000 2R vials), installed in a class C laboratory including:
- Shelves thermally controlled by silicone oil (-60ºC to +60ºC)
- Low temperature condenser -80ºC
-Ultimate vacuum 0.01mbar
-Vacuum control through proportinal leak (GN2 or clean air)
-Stoppering system
-Vacuum sensors: Pirani and Capacitive (integrated at the lyophilizer)
-Product sensors: five PT100 wired
-Wireless sensors: Thermocouples and Pirani
-Acquisition system: with printable trends
GMP sterile pilot facility for clinical studies
Production pharmaecutical facility for clinical batches including:
-Filling and half stoppering unit: 1.500 2R vials per hour
-Freeze dryer: 2m2 (batch 8.000 2R vials)
-Capping machine: 1.500 2R vials per hour
Production in class A with minimum human interaction, compatible with GMP Annex 1. For RTU vials in trays with top faced down for flip over. Format parts currently for 2R, 6R and 20R.
For special requests contact us.