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저자:medicilon 업로드:2021-05-14 조회수:
Safety assessment lab of process chemistry
In the research and development process of innovative drugs, the chemical process research of drugs plays a pivotal role. During the synthesis process to the scale up process in the laboratory, it is not only about output, but also various errors and risks. Therefore, in the development of innovative drugs, the assessment of the safety of chemical processes and equipment is extremely important.
In January 2017, the State Administration of Work Safety issued the instructions and guidelines on strengthening the safety risk assessment of fine chemical reactions.
Enterprises involved in the key supervision of hazardous chemical processes and Grignard reactions, intermittent and semi-batch reactions of metal organic synthesis reactions, in any of the following situations, must carry out a reaction safety risk assessment:
The new technology and formula used for the first time in China for industrial production and the new process introduced for the first time from overseas and the reaction safety risk assessment has not been carried out.
The existing process route, process parameters or device capabilities are changed, and the safety risk assessment report is not filed.
Production safety accidents have been occurred due to reaction process issues.
Adhering to "Innovation-Driven, Quality First", Medicilon has established a laboratory research platform focused on evaluating the safety of chemical processes to provide clients with customized, accurate and reliable testing data and safety assessments.
Target Reaction Calorimetry | Research on secondary reactions (thermal stability) of raw materials, intermediates and products | |
RC1 | DSC | |
Measure Various Thermal Data | Thermal Process Detection of Chemical Raw Materials | |
Heat Generation Rate | The heat absorption and release, melting point, decomposition temperature, decomposition rate and heat release of a single chemical during the heating process. | |
Heat of Reaction | ||
Reaction Progress | Thermal Process Detection of Chemical Process System | |
Starting Point, Ending Point & Dynamics | Reduce the system to the DSC test system according to the actual ratio, test the decomposition temperature, decomposition rate and decomposition heat of the entire system | |
Process Safety and Scale-Up | Kinetic Process of Ddecomposition Reaction | |
Determination of Adiabatic Temperature Rise Maximum Temperature MTSR Heat Conversion Rate Specific Heat Capacity Cp Heat Transfer Coefficient: U Heat Accumulation vs Time Curve | TD24, Activation Energy Ea, Pre-reference Factor A, Predict and Evaluate the Safety of Chemical Reactions | |
Fully Automatic Control | ||
Mixing\Feeding\Pressure\PH Control | ||
High Hr, Fast Kinetics | ||
High Risk | Low Risk | |
Trigger a second reaction? | No further testing required | |
Adiabatic Test | ||
ARC | ||
Starting Temperature; Pressure Data; Adiabatic Temperature Rise; TMRad; Heat Release; TD24; Heat Release Rate |
Levels of Danger | Process Risk | Actions Needed |
Level 1 & Level 2 | Low Process Risk | No Actions Needed |
Level 3 & Level 4 | Process is Danger | Technical Actions Needed |
Level 5 | High Process Risk | Redesign the Process |
METTLER TOLEDO RC1mx
Automatic Reaction Calorimeter RC1mx
Model: METTLER TOLEDO RC1mx
AP01 - Atmospheric Temperature: -73 - 230 Reaction Volume: 0.5L Pressure: 50m bar (Atmospheric) |
HP60 - Autoclave Temperature: -10 - 250 Volume: 1.5L Pressure: 60 bar |
Reaction Temperature Tp | 48 |
Reaction System Quality Mr(g) | 230.7 |
Heat Transfer Coefficient | Before Reaction |
After Reaction | |
Specific Heat Capacity of Reaction Material Cp | |
Temperature Difference between Reactor and Jacket Tr-Tj | 2.7 |
Maximum Specific Heat Release Rate | 49 |
Reaction Heat Accumulation Acc (%) | 5.7 |
Reaction Heat Release Q(KJ) | 83.2 |
Reaction Heat Release Ratio | 360.6 |
Molar Reaction Enthalpy | 213.3 (Calculated based on the molar amount of benzonitrile input) |
Adiabatic Temperature Rise | 103.2 |
Highest Temperature for Synthesis Reaction MTSR | 54.1 |
Highest temperature when the Heat Accumulation Degree is 100% for Synthesis Reaction MA《T | 151.2 |
DSC
DSC Test Data
Decomposition Heat (j/g) | Description | |
1 | Decomposition Heat < 400 | Potential Explosion Hazard |
2 | 400 < 1200 < 1200 < Decomposition Heat < 1200 | The release of heat is large, and the potential explosion risk is high |
3 | 1200 < 3000 < 3000 < Decomposition Heat < 3000 | Large heat release, high potential explosion risk |
4 | Decomposition Heat>3000 | The release of heat is very large, and the potential explosion risk is very high |
Sample Size (mg) | 8.872 |
Heat Release (mJ) | 1141.80 |
Specific Heat | 128.70 |
Initial Decomposition Temperature | 147.12 |
Pre-reference Factor | 20.04+/-0.29/td> |
Reaction Activation Energy | 91.29+/-1.01 |
Reaction Level | 0.87+/-22.04e-03 |
TMRad (min) | |
TD24 | 57.4 |
Adiabatic Accelerating Calorimeter ARC
Temperature/Pressure - Antoine Equation Curve
TMR Fitting Curve
Initial Exothermic Temperature | 114.5 |
Initial Temperature Rising Rate | 0.022 |
Maximum Temperature Rising Rate Temperature | 188 |
Maximum Temperature Rising Rate | 10.904 |
Maximum Pressure Rising Rate | 14.687 |
Maximum Temperature | 197.1 |
Maximum Pressure | 53.277 |
Adiabatic Temperature Rise | 82.6 |
Heat Release | 1247.47 |
Specific Heat | 207.912 |
TD24 | 103.6 |
Reaction Level | 0.84 |
Activation Energy | 160867 |