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Drug Substance (APIs, Intermediates, RSMs)

Process Safety Assessment

It is essential to conduct all pharmaceutical manufacturing processes in a safe manner. Equipped with the advanced instrument including RC1e, DSC, RSC, ARC, C80, explosion limit tester, friction sensitive tester, and closed cup flash point tester,PharmaBlock has a dedicated process safety team to collect comprehensive data and support all the HAZOP analysis, identify potential safety risks during scale up, and help chemists to optimize and prove the robustness of the process. Comprehensive safety evaluations usually begin immediately once a project is accepted and run parallel to process development activities.

1608737152944241z7jX.pngPharmaBlock Process Safety Laboratory has been accredited by China National Accreditation Service for Conformity Assessment (CNAS) (Registration No.: CNAS L13658). The accreditation of the Process Safety Laboratory recognizes PharmaBlock’s capability and qualification to serve the process safety assessment needs in the area of pharmaceutical process development and manufacturing. CNAS is a national accreditation body responsible for accreditation of certification bodies and laboratories. It was established with the approval of the National Certification and Accreditation Administration of the People's Republic of China (CNCA). CNAS also cooperates with International Laboratory Accreditation Cooperation (ILAC), demonstrating its international prestige and recognition.

Assessment Capability

Substance Screening

•  SDS database

•  Thermal stabilities database

•  Friction and impact sensitivity

•  Identification of high-hazard substances

Reactions Calorimetry Measurement

•  Reaction enthalpy

•  Heat accumulation

•  Adiabatic temperature rise

•  Heat/gas release rate

•  Process risk evaluation and analysis

Risk Assessment

•  Oxygen balance

•  Yoshida correlation

•  Corrosion rate

•  Predictive heat of reaction

•  Explosion risk calculation

Click here to know more about our INSIGHTS & CASE STUDIES of process safety assessment