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Safety assessment lab of process chemistry

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.

Safety Assessment Process

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

Safety Assessment Laboratory

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

RC1 Reaction Calorimetry Test Data list

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

Differential Scanning Calorimeter DSC

DSC

DSC Test Data

Decomposition Heat Evaluation List

  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

Adiabatic Accelerating Calorimeter ARC

ARC Test Chart and Data

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

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