Home › Mechanical Engineering Services › Pharmaceutical Engineering Consultants
Home › Mechanical Engineering Services › Pharmaceutical Engineering Consultants
For drug and chemical makers and their OEMs: reactors, vessels, and skids
Get the process right before validation. Free assessment and roadmap.
The challenge
Poor mixing in reactors and tanks leads to uneven batches, longer cycles, and failed lots.
Review: Batch record
→
What changes
Our pharmaceutical engineering consultants model how each impeller and baffle mixes, before you scale up.
The challenge
Reactors and vessels must meet ASME code. One missed detail stalls the whole project.
Review: ASME VIII
→
What changes
Walls, nozzles, and supports are checked in FEA, with the calculations your inspector needs.
The challenge
Jackets and coils that can't remove heat fast enough limit batch size and safe operation.
Review: Process safety
→
What changes
Heat transfer analysis sizes jackets and coils to the reaction, with margin you can see.
The challenge
Every change to a validated process means new paperwork, so it must be right the first time.
→
What changes
Each change is modeled and documented before it reaches your validation team.
Reactor, mixer, vessel, and skid OEMs, plus biotech startups: we act as your engineering team on equipment.
Your extra design team.
Get Your Free RoadmapDrug and chemical makers: we define and design the process equipment you need, then work with your OEM.
Your process, our design.
Get Your Free RoadmapManufacturer and OEM in one design loop, so mixing, heat transfer, and GMP validation data come out together.
One loop, both sides.
Get Your Free RoadmapBring your own manufacturer, or work with our partner network. We take the designs we engineer as far as you need. We don't manufacture, so we never compete with the OEMs we partner with.
Facts about how we work, not project results. One team engineers your product from analysis to delivery, and calculations carry a PE stamp where required.
01
Process equipment with the mixing and heat transfer data your GMP validation file needs behind it.
02
CFD and FEA results you review and approve at each gate, before anything reaches your validation team.
03
You own the IP by default. When an OEM or partner manufacturer is involved, the contract spells out who owns what.
04
If we missed it in our QC, we fix it. If your supplier can't make the part within three years, or supply dries up, we fix that too.
You send
What we need to start
Process data: batches, reactions, and rates
Drawings or CAD of vessels and skids
Current problems: mixing, heat, or yield
Codes and validation rules that apply
Targets: batch size, cycle time, or schedule
→
You get
What you hold at the end
Design: CAD and drawings ready to build
CFD and FEA results you approved
PE-stamped ASME calculations where required
Documentation for your validation team
Support through installation and qualification
We price to the value we deliver, not the hours we log. If the value isn't there for you, we'll say so in the assessment.
Model mixing, blending, and flow in reactors and tanks, so batches stay uniform before you scale up.
Uniform from the start.
Used For
Mixing
Reactors
Scale-Up
Design reactors and vessels to ASME Section VIII, with FEA on walls, nozzles, and supports before build.
Calcs ready to review.
Used For
ASME VIII
Nozzles
Supports
Size jackets, coils, and heat exchangers to your reactions, so heat comes out fast enough to stay safe.
Keep the heat in check.
Used For
Jackets
Coils
Exchangers
Design skids, mixers, and process equipment, with the build managed through your OEM or our partners.
We manage the build.
Used For
Skids
Mixers
Equipment
Public benchmark
CFD-matched mixing carried a dissolution step from 2 L to 4,000 L, a 2,000-fold scale-up (AAPS, 2010).
What it means for you
CFD made the production vessel mix the way the lab vessel did, so results carried across the scale-up. We apply the same method to your reactors and vessels, with data your validation file can use.
The public record shows what the method can do. What it does for your equipment depends on your constraints, and the free assessment tells you.
Maker, OEM, or both: we set the model, the builder, and the hand-off.
Scope, priorities, validation needs, and gates.
CFD, FEA, and design on the equipment, checked in our QC.
Drawings, calculations, and validation documents.
Installation and qualification support, and later changes.
You approve the design at every gate, so nothing that affects function surprises you. If we missed something in our QC, we fix it. If a supplier can’t make a part within three years, we fix that too.
Scale-up or new line coming? Send the process data. Free roadmap.
Chambers, vaporizers, and vacuum systems engineered for EtO sterilization operators, built by partners.
Engineered, then built.
Applications
Chambers
Vaporizers
Vacuum
Kilns, mills, and coolers that run hot, dusty, and nonstop, engineered for heat, wear, and long uptime.
Fewer surprise stops.
Applications
Kilns
Mills
Coolers
Aerospace to data centers: see how one engineering team solves hard constraints across ten industries.
Find the one like yours.
Industries
Aerospace
Mining
Data Centers
Fixed scope for one project. A lower-risk place to start when you want to see our work on your data.
Start with one project.
Fits When
One Project
Fixed Scope
From $35K
Scheduled monthly engineering for recurring needs: drawing updates, ASME calcs, or FEA for each sale.
Work on a set schedule.
Fits When
Monthly
Recurring
From $15K/mo
A dedicated PPS team working your program daily, built for long, multi-year development and testing.
Your program, every day.
Fits When
Daily Work
Multi-Year
From $800K/yr
Gold · One project: a reactor, mixer, or vessel that limits your batch or yield.
Platinum · Ongoing work: engineering support across scale-ups and line changes.
Diamond · A long program: a dedicated team for a new line or plant expansion.
FEA, CFD, CAD, DFMA, and testing under one roof. Engineering is a team sport, and you get the whole team.
One team, every skill.
Under One Roof
FEA
CFD
CAD
DFMA
Testing
Veteran-owned SDVOSB status gives defense and federal buyers a set-aside path to proven engineering.
Verify our SDVOSB status.
Credentials
SDVOSB
VOSB
CAGE 8ZK73
NAICS 541330
Missed something in our QC? We fix it. Supplier can't make the part within three years? We fix that too.
Support for the long run.
We Fix
Our QC Misses
Supplier Gaps
Supply Chain
We price to the value we deliver, not hours logged. You buy a design that works, not more iterations.
Pay for the result only.
Collections
Gold
Platinum
Diamond
What do your pharmaceutical engineering consultants do?
Our pharmaceutical engineering consultants work on the equipment that makes your product: reactors, mixers, vessels, and process skids. Most plants feel the limits as uneven batches, slow heat removal, or a vessel that won't pass review. Each of those problems starts in the design, long before the first batch. A reactor that mixes well at pilot scale can fail at production scale. Jackets sized by rule of thumb can cap your batch size. Pressure vessels must meet ASME Section VIII, and a missed nozzle detail can hold up the whole project. Fixing any of these after startup costs far more, in time and in lost batches.
Fluid flow simulation shows how each impeller and baffle mixes. Heat transfer analysis sizes jackets and coils to the reaction. Chemical reactor design brings those results into equipment your plant can run. Vessels get FEA on walls, nozzles, and supports, with the calculations your inspector needs. We engineer the equipment and the validation evidence behind it. Your team keeps formulation and regulatory filings, and you approve each gate.
How do you handle changes to a validated process?
In a validated plant, every change costs more than the engineering. Our pharmaceutical engineering consultants know a change needs review, documentation, and often new qualification runs. So it has to be right the first time, or the plant pays for it twice, once in engineering and once in review. The FDA's process validation guidance treats validation as a lifecycle, so a weak change can reopen work you thought was closed. A change that fails in qualification costs time, batches, and the trust of your quality team. Questions asked late in review slow every step after them, and the line waits while answers are found.
We model each change before it is made. CFD and FEA show how a new impeller, jacket, or vessel will perform. The change that reaches your validation team comes with plain documentation: what changed, why, the analysis behind it, and the risks it addresses. Your quality team keeps control of validation. We supply the engineering evidence, written to your own templates, so nothing needs rework later.
Can PPS work with our OEM or manufacturer?
Yes. Pharmaceutical engineering consultants from PPS fit the partnerships that are normal in drug and chemical plants. We work in one of three models. As your OEM partner, we act as your engineering team. Operator-led, we design the equipment and work with the builder you choose.
When design, build, and test sit with different companies, problems pass back and forth. The builder works from an old drawing, and each party defends its own scope. The Department of Defense's IPPD Handbook organizes programs around integrated product teams for this reason. In a joint program, the operator and the OEM work with us in one loop.
We engineer the design and coordinate the builder in one loop. Bring your own manufacturer, or work with our network of fabricators, machine shops, and test labs. You decide how far we take the design, up to the start of production. We never run production, so we never compete with your OEM. NDAs cover every party, and you own the IP by default, set in your contract.
What do you need from us to start?
To start a project with our pharmaceutical engineering consulting, send what you have, in any format. That usually means process data such as batch sizes, reactions, and rates, plus drawings or CAD of the vessels and skids. Add the problems you see, the codes and validation rules that apply, and your targets. Batch records help too. Missing data is the most common reason engineering projects stall, because a model built on guessed inputs gives a guessed answer. That is why we don't start the work until every data set is in.
Once it is, the first step is a free assessment of your project scope. We confirm what the work can and can't answer, and tell you what is still missing. Then we send a roadmap proposal with scope, targets, and approval gates. Every project is scoped on its own, so the roadmap sets the schedule, not a stock promise. NDAs are available before you share any files. For gaps in material data, NIST material measurement data is a good first stop.
Who owns the design and the models?
You own the design, the drawings, and the models from your pharmaceutical engineering consulting project by default, as set in the contract. When an OEM or partner manufacturer is involved, the contract spells out who owns what. Some firms keep the models, or license them back to you, so every later change sends you back to them. That locks your product to one vendor and makes design reviews harder, because your team can't open the evidence behind the decisions. You receive the native CAD, the drawings, the simulation model files, and the documented results. Your engineers can then check the work, rerun a load case, or hand the package to a supplier or customer.
We sign mutual NDAs before any of your data is shared, and your files stay in our controlled project folders while we work. If your program has export-control or customer data rules, tell us at the start and we will set up the data handling to match them. For defense programs, the State Department ITAR guidance sets the rules we follow.
What happens if a prototype fails in test?
If a prototype fails in test, we find out why and fix the design. Hard engineering carries unknowns on any project: real loads, material lots, and assembly effects never match a model perfectly. With pharmaceutical engineering consulting from PPS, you approve the data at each gate. A test result is then checked against predictions you have already seen, not a black box. A failure in test is data. It shows which assumption was wrong: a load, a material property, or a boundary condition. That data improves the model and the design.
When testing is in scope, we plan the test to confirm the margins that matter most. Then we correlate the model to the results, following ASME verification and validation practice. If the miss was ours, because something slipped through our QC review, we fix it. If the test uncovers a condition nobody knew about, we scope the change with you and update the roadmap. Either way, you get a clear answer and a path to a design that holds.
How is pharmaceutical engineering consulting priced?
We price pharmaceutical engineering consulting to the value it delivers, not the hours we log. Hourly billing rewards extra iterations, so the cheapest quote often becomes the most expensive project once tooling, rework, and field failures show up. Our incentive is to get the design right the first time. We engage by fit, not as a ladder. Gold (from $35K): you have one project and need help with it. Platinum (from $15K/mo): you have recurring work at a steady rhythm. Diamond (from $800K/yr): you have a long development program, often multi-year.
Gold is never required, and some clients start at Platinum or Diamond. These are starting points, not quotes; your roadmap sets the price. We price to the value we deliver, not the hours we log. If the value isn't there for you, we'll say so in the assessment. Our engineering consultant pricing page explains how each collection works in more detail.
Batches uneven or heat limiting output? Send your data now.
Send your process data, drawings, and problems. We review your project scope in a free assessment and reply within one business day with next steps.
On-site assessments that require travel are quoted separately.