Our industry Solutions
Process Safety Solutions for the Pharmaceutical Industry
Our solutions for hazard assessment and process management play a crucial role in identifying and minimizing the potential risks associated with fire and explosion hazards across the entire operational lifecycle. From the initial stages of development and production through to commercial scale and sale, we actively identify, evaluate, and mitigate hazards.
Supported by a diverse team of global engineers and technical experts, we specialize in delivering customized process safety consulting, testing, and training solutions specifically designed for the pharmaceutical industry.
Do these challenges sound familiar?
Accurately identifying chemically stable reagents, intermediates and mixtures
Chemicals, gas, solvents and excipients are prone to unique hazards and hazard reactions that pose serious risks. Testing is required if a material is filtered, crystallized, heated, purified, dried or milled as its chemical properties may change
Correctly implementing and maintaining a top down safety culture
A rigorous top down safety culture that includes the discovery, process chemistry and commercial teams must be implemented and managed to ensure process safety continuity
Quickly identify and mitigate threats while rapidly scaling production operations
You must quickly and cost-effectively identify and mitigate significant hazard risks connected to equipment and materials via a hazard assessment in order to prevent delays during the lab scale-up process
Safely integrate new technology and manufacturing equipment
If additional manufacturing or lab equipment must be purchased and quickly integrated, there must be stringent checks to ensure that they are fit for purpose and correctly classified for any potentially hazardous zones or areas
YOUR PHARMACEUTICAL PROCESS SAFETY PARTNER OF CHOICE
Sigma-HSE provides actionable process safety solutions to the pharmaceutical industry by eliminating the threat of fire and explosion throughout the entire operational lifecycle.
Our team of global engineers and technical experts can implement a range of process safety consulting, testing and training solutions across your business.
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Protect your Supply Chain
Ensure that any material change to your process or basis of safety has been correctly managed. Process alterations require specialist risk assessments, material testing and operator training
Maximize Efficiency
Ensure that any material change to your process or basis of safety has been correctly managed. Process alterations require specialist risk assessments, material testing and operator training
Consolidate your safety skill gap
Ensure that every one of your qualified workplace operators understands the critical role that process safety plays in their daily tasks by optimizing your pharmaceutical process development productivity and organizational safety culture
Pivot stress free
From R&D to pipeline development and commercial drug expansion, make use of our insights and unmatched turnaround time to optimize any potential pivots in your processes
Common hazards associated with pharmaceuttical production
Inadequate dust containment and housekeeping at active pharmaceutical ingredients (APIs) handling units such as material charging, blending, granulation, fluid bed drying, vacuum drying, grinding, sieving, milling, compression, coating, dust collection, and micronization could present fire or flashfire hazards
Dust cloud formation during the transfer of active pharmaceutical ingredients (APIs) powder into bins which could present a fire or flashfire hazard in the presence of credible ignition sources such as unrated electrical equipment (electrical fixtures, motors) and electrostatic discharge from ungrounded equipment
Dust cloud formation inside dust collectors and bins which could present a deflagration hazard
Fire hazard inside dryers due to self-heating of material
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Your single process safety solution
Protect your vital assets and ensure supply continuity
Our dedicated global team of engineers, technical experts and specialist coaches provide pragmatic and effective solutions that work in harmony with your pharmaceutical manufacturing operations.
Ensure continuity by optimizing your development pipelines against the risk of fire and explosions. Our actionable insights and data keep your employees, infrastructure and operational demands safe, allowing you to concentrate on providing your vital commercial services.
Sigma-HSE’s approach to process safety in the pharmaceutical industry utilizes a range of holistic tools, methodologies, laboratory testing, engineering expertise and vast knowledge of standards and regulations to develop an approach that is unique to your business and the specific challenges you face.