Process Safety Assessment
The safety and hazard assessment are important aspect of API development. BOC Sciences has established a team of experienced professionals who are responsible for process risk evaluations. Our expert teams perform hazard analysis and operability studies for each manufacturing step prior to scale-up production in the kilo-lab and pilot plants. We are equipped with various professional level process safety assessment laboratories to support safety evaluation during the entire manufacturing process.
Goals of process safety assessment
- Ensure risk-free processes and operations
- Prevent accidents and reduce operational risks
- Develop knowledge of safer and cleaner processes
Figure 1. Overview of quality risk management. (Castillo, F. C.; et al. 2016)
Our Services
To make it easier and better for researchers, BOC Sciences provides process safety assessment service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. We have introduced a fully equipped process safety labs capable of performing rigorous, data-driven and comprehensive process and operational safety assessments to give our customers peace of mind throughout their partnership
- Our team places a great emphasis on ensuring the development of safe and eco-friendly processes as well as operations. Each new inquiry undergoes safety assessment and recommendations are implemented
- A systematic and scientific approach is designed to identify, evaluate and control the hazards involved in each process, including the characteristics of raw materials, reaction mixtures, and intermediate and final products
- Our safety team of experts enable to deliver data related to the thermal stability, quantity and rate of heat release, gas evolution and pressure generation rates, flammability and dust explosions. All the data generated is fully and holistically calculated in a report that includes data and recommended base of safety (BOS) operating ranges for development for the optimization and scale-up
What we offer?
Aiming to optimize the API production process and improve product quality and production efficiency, our process department adopts QbD principles for API process development and strives to select the best route for our customers
BOC Sciences supports customers in all stages of development and has a proven track record of scaling up from laboratory and pilot scale to commercial batch sizes. Our scientists offer technical expertise by a fully integrated department and strong project management capabilities. Maintaining product quality and robustness is key for the successful scale-up, we are committed to helping our customers build robustness and quality into the final formulations via systematically understanding the product and process
Figure 2. Process parameter classification. (Castillo, F. C.; et al. 2016)
Capabilities and advanced technologies
- Fully-equipped safety evaluation labs
- Team with > 70 years of collective experience
- Evaluation of thermal hazard, reaction hazard, operation hazard and dust explosion
- Every stage is thoroughly evaluated for HSE, before scale-up
- Detailed risk-based assessment report preparation, with recommendations for safe operations
Infrastructure & Equipment
- Thermal (screening) safety assessment (thermal hazards)
Differential scanning calorimeter (DSC)
Thermal screening unit (TSu)
- Reaction Calorimetry (reactive hazards)
Simular Reaction Calorimeter (SRC) with automated gas release measurement system.
Adiabatic Reaction Calorimeter (ARC)
- Powder safety Assessment (dust explosion)
Modified hartmann tube (MHT)
Impact sensitivity apparatus
Shock sensitivity apparatus
Surface resistivity meter
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of process safety assessment at competitive prices for global customers. Personalized and customized services of process safety assessment can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Castillo, F. C.; et al. Biopharmaceutical Manufacturing Process Validation and Quality Risk Management. Pharmaceutical Engineering. 2016. 36(3): 82-92.
