Pharmaceutical manufacturing.
We study changes in sterile and secondary manufacturing, from the first feasibility question to handover, and check each one against the suite as it is built.
The challenge.
An isolator or a packaging line depends on room classes, pressure regimes, utilities, qualification status and the change-control history of the room. The site's records rarely agree on all of it.
We reconcile the layouts, P&IDs, HVAC schematics, room and qualification records, monitoring exports and change-control history against what we find when we walk the site. Where the evidence runs out, the verdict says Not Demonstrated and names the measurement or record that would close it.
Services.
Each service is named for the stage your project is in, and each is a deliverable with its scope stated.
- 01Front end
Change and installation feasibility
We check whether the isolator, lyophiliser or packaging line works in the existing suite and inside the shutdown window. The study comes with the discrepancy register, a preliminary layout and an outline of the validation impact. Your project engineer approves it.
- 02Pre-tender existing conditions
Existing-conditions baseline
We attach SyntaGraph™ to the project and record room classes, pressure regimes, air changes and utility headroom as we observe them. The EPCM and the equipment suppliers design and bid against that baseline.
- 03Technology transfer
Tech-transfer feasibility
We check whether the receiving site can take the product or the process, list the gaps between the two sites and give a readiness date. Your MSAT and QA teams carry it into the validation strategy.
- 04Handover and close-out
As-built verification
We check the project's as-builts against the installed suite before acceptance and list the discrepancies you would otherwise meet at the next qualification.
- 05Change control
Change-impact assessment
We draft the engineering, validation and EHS evidence behind a change, with its sources. QA approves the change control in your own quality system.
- 06Shutdown and turnaround
Turnaround readiness
We check scope, access, isolations, permits and physical conflicts against the suite before the shutdown window opens.
SyntaGraph™.
Every study adds to one model of the site. Your project engineers, MSAT and QA open the same objects and see every source behind them.
Facility physics.
A second isolator can shift the pressure cascade, the air changes the suite must keep and the headroom of the air handler that serves it. We turn those questions into analysis cases from the same evidence and class each result as screened, verified, measured or signed.
What the product does inside the process stays with your process engineer. Capabilities are introduced domain by domain, and each proposal states the methods available for the study.
How the physics layer worksQuestions.
Does the study go into our quality system?
The study is a signed engineering deliverable with its evidence attached. Your engineer and your QA reviewer decide what enters the quality system, in your own templates, and every source stays linked.
Who signs the engineering decision?
AI extracts the evidence, reconciles the records and drafts the work. Where the decision needs professional judgment or statutory accountability, a qualified engineer stays responsible for it and for the approval. Today your site's engineer of record signs, and the evidence in front of them shows every discrepancy, every assumption and everything we could not demonstrate. Design on the verified plant comes next, with our own engineer of record.
Can you work alongside our EPCM?
Yes. Before award we give the EPCM your own verified evidence of the suite to design and bid against. After handover we check the as-builts against it.
What happens to our data?
Your data trains nothing without a permission you negotiated. Sources, rights and any reuse are written into the study. You keep your systems of record, and the suite model exports in an open format.
How is a study priced?
Each study has a fixed scope, and the proposal states the price and the turnaround. A repeat study on a site we have already modelled starts from what the earlier work verified, and the proposal reflects that.
Start a study.
Send us the question and tell us where the project stands, whether it is a placement, a transfer, a change control, a handover or a shutdown.