— Where We Work in Pharma & Life Sciences —
API & Fine Chemical Synthesis
Reaction, distillation, extraction, and drying operations where flammable solvents, reactive chemistry, and thermal stability drive the hazard profile.
Solvent Storage, Transfer & Recovery
Bulk solvent tank farms, charging and transfer systems, and recovery units, where adding or moving one flammable material can change the electrical and ignition requirements for everything around it.
Oral Solid Dose Manufacturing
Granulation, fluid bed drying, milling, blending, compression, and coating, where combustible dust and dust collection systems define the risk.
Packaging, Inspection & Material Handling
Filling, inspection, cartoning, palletizing, and warehouse automation, which behave like discrete manufacturing lines with their own safeguarding obligations.
Central Utilities & Boiler Houses
Boilers, regenerative thermal oxidizers, steam plant, and ammonia refrigeration governed by NFPA standards, supporting the whole site.
Toxic & Combustible Life Safety Systems
Engineered life safety systems that handle toxic and combustible gas detection requirements across the site.
— Integrated Solutions for Pharma & Life Sciences Operations —
Pharmaceutical and life sciences manufacturing sites handle flammable solvents in bulk, reactive chemistry in API synthesis, combustible dust in granulation and solid dose processing, anhydrous ammonia refrigeration, and natural gas-fired boiler houses that the entire site depends on. Many of these facilities have been expanded in phases, repurposed between products, and retrofitted around new equipment, making current process safety information essential to understanding how those changes affect hazards and whether existing safeguards are still adequate.
aeSolutions helps pharmaceutical and life sciences manufacturers identify their hazards and size the protection those hazards require, then design, build, and support commissioning of the automation and safety systems. Process safety, functional safety, alarm management, combustion systems, fire and gas life safety systems, and automation all come from the same team, so the hazards identified in the PHA carry through design, panel fabrication, and commissioning without another vendor interface that you have to manage.
— Pharma & Life Sciences By the Numbers —
25+
Years Serving Pharma & Life Sciences Clients
27
Pharma & Life Sciences Sites Supported
159
Pharma & Life Sciences Projects Delivered
— The Challenges We Solve —
And The Capabilities We Bring
FIRE & GAS DETECTION
Many different gases, across many different rooms
A pharmaceutical site rarely has one gas hazard. It has dozens, often uncommon ones, spread across synthesis suites, utility buildings, and storage areas, with different exposure limits and different detection technologies. Cross-sensitivity between gases in the same space has to be addressed in detector selection and placement. We develop the gas detection philosophy first, so alarm levels, sensor ranges, and detector placement follow the physical properties of what is actually present, then we design and fabricate the life safety system around it.
DUST HAZARD ANALYSIS
Combustible dust through solid dose processing
Granulation, fluid bed drying, milling, blending, and compression all generate dust, and so do the collection systems built to capture it. Many active ingredients and excipients are combustible, and the deflagration risk sits inside equipment that was specified for product quality rather than for explosion protection. A Dust Hazard Analysis under NFPA 652 identifies where deflagration is credible, and the resulting protection has to be engineered into the equipment and the control system.
FUNCTIONAL SAFETY
Safety functions nobody can prove still work
Interlocks accumulate across product changes, expansions, and equipment replacements, often without a Safety Requirements Specification, SIL verification, or proof test record. Our CFSEs determine required SIL, verify achieved SIL, write the SRS, and build the proof test procedures that make the claim defensible under ANSI/ISA 61511. Safety Instrumented Systems that are documented properly are also easier to explain to an auditor.
PROCESS SAFETY
PSM and RMP obligations alongside FDA compliance
Quality systems and process safety are not the same program, and a site that is audit-ready for one can be exposed on the other. Where flammable solvent inventories or anhydrous ammonia refrigeration cross threshold quantities, OSHA PSM 1910.119 and EPA RMP apply in full. Adding a new tank, solvent, or process to an existing area can change the hazardous area classification of the equipment already there, which should be checked in a hazard review. We rebuild the process safety basis, facilitate the PHA and LOPA, and carry the findings into engineering design.
AUTOMATION AND CONTROL
Control systems past vendor support, with no window to replace them
Campaign schedules and validated production leave little room for a control system migration, even when a platform is past vendor support. We plan DCS and PLC migrations around production reality, with I/O cutover planning, staged commissioning, and functional and design specifications written so your validation team can qualify the system.
BURNER MANAGEMENT
A boiler house the entire site depends on
Many pharmaceutical sites rely on on-site boilers for steam, including for cleaning processes. Boilers, regenerative thermal oxidizers, and fired equipment often run on burner management logic that predates current NFPA 85 and NFPA 86, and hardwired interlocks that may not have been tested recently. We design, fabricate, and commission BMS and combustion control systems to code, and factory acceptance test them before they reach your site.
— One Team, Not Five Vendors —
Most firms serving pharmaceutical and life sciences manufacturing do one thing. A process safety consultant facilitates your PHA and hands you a report. An integrator designs and programs your control system platform. A panel builder fabricates and ships you a cabinet. Each is competent, but no one is responsible for the handoffs between them, which is where gaps tend to form.
aeSolutions covers the full lifecycle with one accountable team. Validation (IQ, OQ, and PQ) stays with your independent validation provider. Findings from your PHA and LOPA carry into the Safety Requirements Specification and the design, which we fabricate and factory acceptance test in our UL and FM certified panel shop in Greenville, South Carolina, before installation and commissioning at your site.
One team carries the work from the PHA through commissioning.
DISCIPLINE
APPLIED IN PHARMA & LIFE SCIENCES
Process Safety
Gas dispersion modeling, PHA, HAZOP, LOPA, QRA, PSM/RMP auditing, facility siting, Dust Hazard Analysis, hazardous area classification, mechanical integrity
Functional Safety
SIL determination and verification, Safety Requirements Specifications, Functional Safety Assessments, proof test procedures, functional safety management
Automation & Control
DCS and PLC migration, I/O cutover planning, systems integration, HMI design, functional and design specifications, instrument and electrical conceptual design
Combustion Systems
Burner management and combustion control system design for boilers, process heaters, dryers, incinerators, and regenerative thermal oxidizers
Fire & Gas
Toxic and combustible gas detection philosophy development, plume dispersion modeling, detector coverage modeling, conceptual and detail design, FM approved system fabrication, commissioning
Alarm Management
Alarm philosophy, rationalization facilitation, program audits, advanced alarming, implementation support
— Automation & Control Systems for Pharma & Life Sciences —
A pharmaceutical site typically includes several types of operations. The central utility plant runs continuously to support all systems. The API building runs reactions to recipe in batches. The packaging hall at the end typically runs discrete processes. Each demands a different control strategy, and integrating them affects visibility and traceability across the site.
MODE 01
Continuous
Central utilities, solvent recovery, & continuous manufacturing lines run steady-state with tight interaction between pressure, temperature, and flow loops, & everything downstream depends on them staying stable.
Our work centers on regulatory control performance, safe operating limits, and keeping the safety layer independent of the control layer.
TYPICAL SCOPE
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DCS and PLC migration with staged I/O cutover
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Functional and design specifications
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Advanced regulatory control and loop performance
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BPCS and SIS independence verification
Safe operating limit definition
MODE 02
Batch
Reaction, formulation, granulation, and blending operations run to recipe, where the sequence itself carries the hazard. Charge order, temperature ramp, and hold time affect both process safety and product quality.
We build batch control that is structured, auditable, and able to fail safe mid-sequence.
TYPICAL SCOPE
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Structured batch control and recipe management
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Sequence and phase logic with interlock alignment
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Reactive chemistry review feeding control strategy & process safety
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Batch reporting, electronic records, genealogy
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Safe-state definition and sequence hold or abort
MODE 03
Discrete
Filling, inspection, labeling, packaging, palletizing, and warehouse automation behave like discrete manufacturing lines, with high throughput, frequent changeover, and equipment that is difficult to guard without slowing it down.
Machine safeguarding, safety-rated control design, and throughput reliability all have to be designed together.
TYPICAL SCOPE
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Machine safeguarding and safety-rated control design
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Robotic and automated system risk assessment
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Packaging and material handling integration
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Safety function performance level verification
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Line performance and downtime analysis
— Platforms and Fabrication —
— Siemens —
aeSolutions has been a Siemens Solution Partner since 1999 and was the first company in the Americas to earn Siemens' PCS 7 Safety Specialist certification.
— Rockwell —
aeSolutions is a certified Rockwell Systems Integrator. This allows us to ensure we can provide the best possible solution and exceptional support with the least amount of risk for your company.
We work across Siemens, Rockwell, Emerson, and other major platforms, and we fabricate, configure, and factory acceptance test complete systems in our own certified panel shop before anything ships to your site.
— The aeSolutions ResiliencePath™ Method —
We’re an integrative specialist with a proven methodology that we call ResiliencePath™ that embeds safety into every stage of the project lifecycle — from concept to closure — for compliance today and resilience tomorrow.
Empowering — Not Enforcing
Rather than checking boxes, we help you identify the right questions early to prevent costly late-stage corrections and avoid years of OpEx fixes. Each ResiliencePath™ step is driven by one goal: empowering resilient, value-aligned decisions that stand the test of time.
EPC & Subcontractor Integration
ResiliencePath™ is adaptable to collaborate seamlessly with EPCs and subcontractors, integrated into a structured workflow designed to adapt to real-world project dynamics without compromising on results.
Your Process, Our Expertise
At aeSolutions, we help pharmaceutical and life sciences manufacturers reduce risk and improve operational resilience by integrating hazard engineering and safety system design into real-world project execution. Our capabilities span process hazard analysis, functional safety, gas detection philosophy and design, burner management, and control system modernization.
We work with your team to close gaps, clarify responsibilities, and convert fragmented practices into a unified approach that protects people, assets, and uptime. Whether you're navigating a revalidation or rethinking your strategy, aeSolutions helps you move from risk to resilience with clarity and confidence.
— DON'T JUST TAKE OUR WORD FOR IT —
Evidence-Backed Results
