COMPANY OVERVIEW
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Location – Cardiff, Wales, UKFounded 2004
PROCESSCHEMISTRY SERVICES
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MANUFACTURING CONTROL
ROUTE DEVELOPMENT
PROCESS OPTIMISATION
PROCESS ANALYTICS
CUSTOM SYNTHESIS
ROUTE SCOUTING
QUALITY BY DESIGN
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MM1117-4 linear cooling followed by warm up to encourage growth
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Time (minutes)
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Temperature (°C) Turbidity (%)
MM1117-4 non-linear cooling, exponent = 0.2
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Tim e (m inutes)
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Temperature (°C) Turbidity (%)
MM1117-4 non-linear cooling, exponent = 5
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1 31 61 91 121 151 181 211 241 271
Tim e (m inutes)
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(°C
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Temperature (°C) Turbidity (%)
CRYSTALLISATIONPROCESS R&D - CONTROLLED STUDIES
Process Crystallisation Studies
• 4 x 50 ml reactors• Independent heating and cooling• Automated solvent-reagent dosing, quenches and dilutions• Independent agitator control• In-situ turbidity measurement• Raman Monitoring• pH Monitoring
CRYSTALLISATION DEVELOPMENT
Design-Expert® Software
Correlation: -0.035
Color points by
Run31
1
X1: Design ID
X2: C:Seed conc
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22
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34
56
78
910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
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Design-Expert® Software
conversionDesign Points98
2
X1 = B: TempX2 = C: Seed conc
Actual FactorsA: conc = 0.15D: Amount seed = 3.35
E: cooling rate = 0.17
48.00 54.00 60.00 66.00 72.000.10
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conversion
X1: B: TempX2: C: Seed conc
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OPTIMISATION & TECHNOLOGY TRANSFER
Robustness Studies
PROCESS UNDERSTANDING
“A system is robust if its sensitivity to changes in certain critical factors, around a setpoint, is within defined limits.”
Key Process Parameter Studies
Fate Of Impurity Studies
Screening Studies
Is the process Robust within acceptable ranges (PAR and NOR)
Process Understanding
Route Scouting
Route Development Studies
CrystallizationDevelopment
Key Process Parameter Studies
(DOE Studies)
Fate Of Impurities Studies
Technology Transfer
PROCESS UNDERSTANDING
PROCESSCHEMISTRY SERVICES
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