Pharmaceutical
Clean utilities that stay in spec. Records your auditor can follow.
A batch is only as good as the water, steam, air and cold rooms behind it. We keep a physics twin of each utility, catch drift before it becomes an excursion, and put every finding, approval and repair on a signed record. Your validated systems stay the record of truth. We make sure the equipment behind them doesn’t surprise you.
The clean utilities behind a batch
Three paths run side by side. Water goes from the still to the hot loop. Steam sterilizes parts, and product moves on to drying and cold storage. Air goes through HEPA filters into the graded rooms.
- Water
- Air
- Steam
- Product
- Has its own twin page
What costs you money
Where the money goes today.
Excursions found after the fact.
A cold room drifts overnight, and the deviation report costs more than the repair.
Utilities that fail mid-campaign.
A WFI pump or sterilizer goes down and the line waits.
Cleanroom air running flat out.
The air system runs at full air changes around the clock, including when rooms are empty.
Paper trails for every repair.
Maintenance on GMP equipment needs a record that stands up in an audit.
The machines we know
The utilities behind every batch.
Each one has a physics twin built from its nameplate, its curves and the ways it fails. The WFI loop comes first, because the whole plant draws on it.
- Lead assetWFI distribution loopThe loop must stay hot, fast and clean. Pump wear shows up first as lost velocity.Hot WFI loop, 80 °C, 6 m³/h, DN40 316L, return ≥ 1.0 m/s, 5.5 kW sanitary pump on a driveOpen the wfi distribution loop
- AssetCleanroom air handlerAir changes and pressure steps keep the room clean. Filters and fans decide what it costs.20,000 m³/h air handler, drive-fed plug fan, terminal HEPA, Grade C suite, 10–15 Pa stepsOpen the cleanroom air handler
- AssetGMP cold roomThe excursion starts hours before the alarm. The compressor shows it first.2–8 °C walk-in cold room, 40 m³, duty and standby condensing units, electric defrost, −80 °C freezers on the same pageOpen the gmp cold room
- AssetSteam sterilizerSteam kills by temperature. Air in the chamber is what stops it.Porous-load steam sterilizer, 600 L chamber, 121–134 °C cycles, vacuum-pulse air removal, clean steamOpen the steam sterilizer
- AssetFreeze dryerA slow leak or a tired vacuum pump stretches every cycle. The twin sees it cycle by cycle.Production freeze dryer, 20 m² shelf area, condenser at −70 °C, chamber 50–200 µbarOpen the freeze dryer
Also watched on site
- Purified water generation (RO and EDI)
- WFI stills
- Clean steam generators
- Process compressed air and nitrogen
- Chilled water and process cooling
- Incubators and stability chambers
How a job goes
A WFI pump wears slowly. Here is how we catch it before the loop leaves its range.
- 01 Watch
TwinEdge OS reads the WFI loop’s flow, temperature and conductivity from the existing controller.
TwinEdge OS - 02 Find
Return velocity is falling about 2% a month at the same pump speed. Discharge pressure fell with it, so the twin traces it to pump wear, not a valve change.
Agentic Analytics - 03 Fix
A work order is drafted for the next planned shutdown. The engineer approves it, and QA signs the change with stated intent and meaning.
CMMS / EAM - 04 Prove
Velocity and pump power go back on the curve after the repair, and the signed record shows who did what.
TwinEdge Historian
What we connect to
We read what you already have.
At the site
- Utility PLCs and skid controllers (OPC UA, Modbus, EtherNet/IP)
- Smart transmitters through HART gateways (HART-IP)
- Building management (BACnet)
- Data loggers (MQTT)
Your systems
- Your environmental monitoring system, as a read-only source
- CMMS
- Historian
What we put a number on
Worked out from the equations, before we start.
Air handler, fewer air changes at rest
33,626 kWh a year
25 to 15 air changes in empty rooms, 7.3 kW, $4,035 in fan power. Only if QA approves the change.
Modeled
Warning before a cold-room excursion
19 hours
From the compressor running without stopping to the probes passing 8 °C, after a defrost heater fails.
Modeled
WFI pump wear against the curve
13 weeks
Flagged before return velocity at peak draw falls under 1 m/s. The pump draws 1.79 kW, 15,706 kWh a year.
Modeled
Sterilizer time lost to a tired vacuum pump
83 hours a year
2.5 more minutes of evacuation on every cycle.
Modeled
Modeled on the reference machine. Results vary by site.
What we do not do
Clear lines, so you know what you are buying.
- We are not your validated environmental monitoring system, MES, LIMS or batch record. We read them. They stay the record.
- We do not change a qualified setting. We recommend. Your change control and QA decide.
- We do not claim your system is Part 11 compliant. We give you the controls: signatures with intent and meaning, sign-in again before signing, and a tamper-evident audit trail. Your quality team qualifies them.
- We do not release water, product or a sterilized load. Your release process does.
How you pay
A 90-day pilot. The fee follows the result.
A 90-day pilot on one utility system. We baseline it first, then measure the change. The fee is tied to the measured change.
What we baseline first
- Unplanned downtime on the utility
- Alarms and excursions
- Energy use
What we measure after
- Downtime against the baseline
- Alarms and excursions against the baseline
- Energy against the baseline, on the same meters
Questions
Straight answers.
Is TwinEdge GMP validated?
No software is validated on its own. Validation is done by your team, for your use, in your plant. We provide the Part 11 controls and describe how each one works: signatures with intent and meaning, sign-in again before signing, and a tamper-evident audit trail.
Can it change setpoints in a cleanroom?
Not without your change control. It recommends. A person in QA approves.
How are signatures handled?
Each signature records who, when, why and what it means, needs a fresh sign-in, and is chained so later edits show.
Does it replace our EMS?
No. Your EMS stays the record for room conditions. We use its data to find equipment problems.
Where does data live?
On site on the edge, and in your chosen cloud region.
What happens when a cold room starts to drift?
The twin raises a finding first, from compressor run time, while the probes are still in range. If the room does go out, the excursion alert names the unit and how long it has been out of range, escalates at set stages and goes to the person on duty.
What we do for you
We watch it. We catch it. We prove it.
Our reliability engineers run the twins, review every finding, and help your crew fix it. After the repair we compare the meter to the baseline and write the result in the ledger.