Hazard Assessment
A hazard assessment of the designed API manufacturing process should be performed prior to the design of a standard or other less formal job description document are drafted. Aiming to develop safe, environmentally friendly and cost effective processes, BOC Sciences has the capability, experience and license to use or handle these hazardous chemicals in multiple process.
Figure 1. Description of Model-based Vulnerability Analysis (MBVA) methodology (Progoulakis, I.; Nikitakos, N. 2019)
Our Services
To make it easier and better for researchers, BOC Sciences provides hazard 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.
Prioritization of the hazard assessment
Our teams have established following criteria to be used for prioritization:
- Higher daily dose taken
- Long duration of treatment
- Therapeutic indication
- Higher number of patients treated
- Commercial APIs > APIs used for clinical trials
- API manufactured in multipurpose equipment > dedicated equipment
- API manufactured in multipurpose equipment exposed to nitrosating agents
- API > Intermediate > RSM (for companies manufacturing the three categories)
- APIs still manufactured > APIs no longer manufactured but still on the market
- APIs sold to markets where risk assessment have already been requested by authorities
- APIs sold to other markets
- Knowledge of the likelihood of a risk based on the chemistry of the process (presence of amine, nitro functionalities, nitrosating agents)
We can handle these hazardous chemicals as follows
- Reducing agents: iron powder, sodium borohydride, potassium borohydride, lithium aluminum hydride
- Oxidizing agents: hydrogen peroxide, m-phenylene dimethyl ether
- Highly toxic substances: sodium cyanide, potassium cyanide
- Highly reactive compounds: dimethyl sulfate, hydrazine hydrate, phosphorus oxychloride, phosphorus trichloride, phosphorus pentachloride, thionyl chloride
- Explosives: sodium azide, sodium hydride, diazo compounds, azide compounds
Content of the hazard assessment
BOC Sciences fully consider the following possible sources:
- Raw materials: recovered solvents, nitrosating agents, nitric acid, nitrites, dimethylformamide and/or other materials
- Manufacturing process and reaction conditions: conditions forming or suppressing nitrosamines must be assessed such as temperature, pH, carbon treatment, chemical reduction or excess of alcohol
- Purging factors
- Structural study and potential subsequent degradation of the structural fragments
- Water
- Steam, cleaning agents other than solvents, and consumables
- Nitrogen
- Primary packaging: particular attention might be paid to the ones with additives such as antistatic packaging (which might contain specific additives) or packaging for liquid APIs by assessing potential interactions between packaging and API
Figure 2. MSRAM analysis process. (Progoulakis, I.; Nikitakos, N. 2019)
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 hazard assessment at competitive prices for global customers. Personalized and customized services of hazard 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
- Progoulakis, I.; Nikitakos, N. Risk Assessment Framework for the Security of Offshore Oil and Gas Assets. IAME 2019 conference. 2019.
