SECTORS
LIFE SCIENCE
ORS Consulting supports the life science sector with specialist engineering, process safety and risk management services across pharmaceuticals, biotechnology, and other highly regulated process industries, including food and distilled spirits. ORS brings experience across multiple sectors, supported by well‑established risk management practices, such as oil and gas. We recognise both the parallels with, and the important distinctions from, these industries, and our goal is to deliver rigorous risk management that is genuinely suited to the operator’s risk profile and maturity.
How do We add Value?
ORS delivers a comprehensive range of process safety and compliance services across the life science sector, from initial hazard assessments to compliance related support and integrated advisory for operational phases. Our core service offerings include:
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Hazardous Area Classification: Risk assessments for facilities handling flammable substances, as well as development of Hazardous Area Classification drawings, zone schedules, and ignition source registers. The work also includes supporting clients to comply with relevant regulations such as ATEX directives, DSEAR (UK), etc.
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Process and functional safety: ORS supports clients with process safety studies from the initial HAZOP in concept stage until detailed design, including the link to further SIS lifecycle activities further down the line, such as SIL allocation, SRS, SIL compliance, in accordance with IEC 61508 / IEC 61511.
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Regulatory Compliance Support: Many life science facilities hold Seveso/COMAH-listed substances above threshold quantities, carrying defined legal obligations. ORS supports operators preparing necessary documentation for audits and new expansions, e.g., by conducting HAZID, updating consequence modelling, etc.
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Reliability, Availability & Critical Spares: RAM analysis and FMECA for production-critical equipment. Unplanned downtime in life science manufacturing carries significant commercial and reputational consequences as the sites are often classified as socially critical infrastructure. ORS support operators in identifying reliability vulnerabilities, defining critical spares requirements, and structuring maintenance regimes to safeguard production performance.
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Process Safety Training: To build genuine process safety competence within our clients' organisations, ORS develops site-specific process safety training for teams at all levels, from shift operators to senior management, focused on building genuine competence within process safety.
Read more about our experience within the Life Science sector below
Pharmaceuticals
The pharmaceutical and biotechnology industries are governed by the Good Manufacturing Practice (GMP) framework, where product quality, patient safety, and regulatory compliance are inseparable from systematic control of technical and process‑related risks. Safety‑critical systems must not only function correctly, but also be documented, traceable, testable, and governed throughout their lifecycle. Failures, undocumented changes, or poorly controlled modifications to process, automation, or protection layers can lead to batch rejection, regulatory findings, or production shutdowns. Consequently, functional safety activities and process risk studies such as Hazard and Operability (HAZOP) and Layers of Protection Analysis (LOPA) studies must integrate seamlessly with GMP processes, including validation, deviation management, and change control.
Some examples of project engagements
Client: World-leading biopharmaceutical company, Denmark
Project: Integrated advisory within functional safety, supporting the client from the hazard and risk assessment phase, SIL allocation, SRS, SIL Verification and auditing.
Client: Specialised life‑science manufacturing company, Norway
Project: Process safety and HSE support for a facility extension, supporting the client with early hazard identification, prepare and plan HAZOP activities, and manage environmental and operational risks alongside project execution.
Spirit and Distilleries
The distilled spirits industry handles flammable inventories at a scale that places squarely within scope for regulatory scrutiny. Whether you operate a single malt distillery, a large-scale grain plant, or a central blending and bottling facility, the obligations under ATEX (EU) / DSEAR (UK), Seveso/COMAH, and the associated HSE inspection are enforced. Process and functional safety are an effective way to support the distilled spirits sites in understanding and meeting their regulatory obligations. ORS delivers practical, site‑focused studies covering HAZIDs, HAZOPS, SIL/LOPA, ATEX/DSEAR, hazardous area classification and Seveso/COMAH, tailored to the realities of the distilled spirits industry.
Some examples of project engagements
Client: Ethanol production site, Sweden
Project: Support with updating risk assessments as part of Seveso 5-year audit (including HAZID and consequence assessments), as well as training within the process safety domain.
Food Industry
Production of food is often not associated with hazardous substances; however, the supporting systems (e.g., cooling system) may consist of hazardous chemicals that can pose a risk for both personnel, quality, environment and asset. Understanding the key hazards contributing to the overall risk picture beyond the main process is essential for ensuring a safe plant.
HACCP (Hazard Analysis and Critical Control Points) is commonly used in the food industry to identify, evaluate, and control food safety hazards throughout the production process. It addresses biological, chemical, and physical hazards and defines critical control points (CCPs) where control measures are required to ensure food safety. HACCP is recognised as a basis for food safety management within EU and international food regulations.
Some examples of project engagements
Client: Food producer, Norway
Project: Supporting client with hazard identification and consequence modelling of the production plant.
