Why Comprehensive Process Safety Assessments Matter in Pharmaceutical Manufacturing
In pharmaceutical manufacturing, ensuring process safety is a critical requirement—especially when energetic chemistries, such as nitrations, diazotizations, azides, or combustible powders, are involved. Robust safety assessments safeguard personnel, equipment, and infrastructure from hazards that can lead to fires, explosions, or toxic releases. Between 1985 and 2019, 73 documented process-safety incidents in pharma caused 108 fatalities, with explosions responsible for nearly 90% of those deaths, most in China and India. More recently, in July 2025, an explosion at a pharmaceutical plant in India killed at least 40 workers, underscoring that the risk remains current and urgent.
A strong safety culture not only prevents accidents but also minimizes costly downtime. For context, unplanned shutdowns in manufacturing can cost between $100,000 and $2.3 million per hour, depending on the sector. Beyond economics, comprehensive safety assessments protect a brand’s reputation and ensure regulatory compliance under OSHA’s Process Safety Management standard and NFPA combustible-dust rules.
While various frameworks exist for evaluating chemical and process safety, a comprehensive, science-based approach is essential. Without it, organizations risk missing details that directly impact long-term operational success—particularly when scaling high-energy chemistries.
At the regulatory level, OSHA’s Process Safety Management (PSM) standard applies when a process contains highly hazardous chemicals at or above threshold quantities or ≥10,000 pounds of flammable materials. That brings formal requirements for PHAs, operating procedures, training, and emergency planning.
While various frameworks exist for evaluating chemical and process safety, a comprehensive, science-based approach is essential. Without it, organizations risk missing crucial details that can significantly impact their long-term operational success.
Six Core Risk Categories for Process Safety Testing
An effective process safety assessment must examine six distinct risk categories to provide a full understanding of chemical hazards:
- Material Instability – Determines conditions at which material begins to decompose uncontrollably.
- Material Combustibility – Evaluates a substance’s potential to ignite or support combustion.
- Material Reactivity – Assesses the likelihood of dangerous reactions with other chemicals or the environment.
- Material Toxicity – Identifies harmful exposure thresholds and potential impacts on human health.
- Reaction Energetics – Measures the heat released during chemical reactions.
- Gas Release Considerations – Reviews the rate, volume, and nature (toxicity, combustibility) of gases released during the process.
By evaluating across all six categories, organizations gain the data necessary to develop effective controls, mitigate hazards, and maintain a safe manufacturing environment.
Data Interpretation Is Just as Important as Data Collection
Safety assessments should do more than generate raw numbers; they must provide meaningful insight. While tools like chromatograms, statistical control charts, gas generation data, and energetic profiles are critical, they are only as useful as the understanding they provide.
Interpreting this data within the context of probability and severity helps decision-makers understand not just what could go wrong, but how likely it is and what impact it could have. This risk assessment-based approach ensures both safe design and operational efficiency.
SK pharmteco not only conducts these tests but also provides guidance to help clients confidently interpret the results. It’s about transforming technical complexity into actionable safety decisions.
Proven Track Record of Process Safety Leadership
With over 80 years of experience in process safety for energetic chemistry, SK pharmteco has established a reputation for excellence. All three SK pharmteco small molecule sites maintain dedicated process safety teams that provide in-house hazard evaluations and support production-scale problem-solving.
This deep expertise translates into a strong safety record: no fatalities, no catastrophic incidents, and a consistent ability to detect and prevent potential hazards. While smaller CDMOs often lack in-house capabilities—and some overseas partners may withhold safety data—SK pharmteco brings transparency and reliability to every engagement.
Partner with Experts for Safer Chemical Manufacturing
Chemical manufacturing is complex—but safety doesn’t have to be. When working with SK pharmteco, clients benefit from comprehensive testing, expert interpretation, and a commitment to safe, efficient operations.
SK pharmteco leads in energetic chemistry capabilities, particularly with compounds involving high bond energy transformations or unstable functional groups. These challenges require in-depth historical background research, detailed mechanistic understanding, and customized processing equipment, which are readily available resources at SK pharmteco.
The company’s Process Safety Labs support advanced characterization through in-house testing for MIE, Impact, Friction, ARC, DSC, and EasyMax/RC1 data, all backed by experienced staff who know how to interpret and act on results.
In addition, SK pharmteco offers design-build capabilities, with R&D engineers determining equipment needs, a full machine shop and facilities team ready to build custom solutions, and a QA team qualified to test and validate equipment for safety and performance.
Finally, our facilities are designed with consideration for safely mitigating many of the issues inherent in highly energetic processes, allowing for a fast and secure scale-up without the need for associated capital investment.
To explore how SK pharmteco can enhance your process safety strategy and support your manufacturing goals, contact the team today. Discover how deep technical knowledge, unmatched capabilities, and a proven safety culture can help protect your process at every stage.
References
- Jansen, C. U., et al. (2024). Upscaling and risk evaluation of the synthesis of the 3,5-… Processes. (Diazotization scale-up; thermal/kinetic data). PMC
- Kyprianou, D. (2022). Flow chemistry and the synthesis of energetic materials. JRC Report. (Flow as inherently safer tech for energetic reactions). JRC Publications Repository
- Onishi, A., Nagata, T., & Yoshida, H. (2022). Global process safety incidents in the pharmaceutical industry (1985–2019). Process Safety and Environmental Protection. (73 incidents; 108 fatalities; explosion breakdown). Academia
- Schotten, C., et al. (2020). Comparison of the thermal stabilities of diazonium salts and their corresponding triazenes. Org. Process Res. Dev. (Diazonium vs triazene stability; >200 °C typical for triazenes). White Rose Research Online
- Sperry, J. B., Azuma, M., & Stone, S. (2021). Explosive hazard identification in pharmaceutical process development (OREOS). Org. Process Res. Dev. (Explosive-property screening workflow). ACS Publications
- Köckinger, M., et al. (2020). Continuous-flow acetylation and nitration toward an osimertinib building block. Org. Process Res. Dev. (Safe nitration scale-up). ACS Publications
- BJOC Review (2025). Continuous-flow-enabled intensification in nitration chemistry. Beilstein J. Org. Chem. (Recent nitration safety/intensification review). Beilstein Journals
- NIOSH. (n.d.). Sodium azide—NIOSH Pocket Guide; IDLH table. (HN₃ REL 0.1 ppm; ceiling). CDC+1
- ACGIH/State RTK. (2013). Sodium Azide Fact Sheet. (ACGIH TLV 0.11 ppm HN₃ ceiling; 0.29 mg/m³ NaN₃ ceiling). NJ.gov
- NFPA. (2019). NFPA 652: Standard on the Fundamentals of Combustible Dust. (DHA expectation). awpa.org
- OSHA. (2019). OTM: Combustible Dusts, Ch. 6. (MEC ranges; MIE can be as low as 1–3 mJ). OSHA
- SDS (multiple vendors, 2014–2025). Magnesium stearate dust explosivity: MIE 3–10 mJ, Kst ≈ 259 bar·m/s, MEC 20–30 g/m³.