Pharmaceutical

Cleanroom air handler

Air changes and pressure steps keep the room clean. Filters and fans decide what it costs.

A cleanroom air handler runs all day, every day, and it is often the biggest load in the plant. Clean air comes from air changes and pressure steps from room to room. The twin checks each filter, the fan and every door step, and shows what fewer air changes in empty rooms would save.

20,000 m³/h air handler, drive-fed plug fan, terminal HEPA, Grade C suite, 10–15 Pa steps

Built and run to EU GMP Annex 1, ISO 14644-1

Section through a cleanroom air handler: mixing box with outside and return air dampers, pre-filter, cooling and heating coils, plug fan on a drive and final bag filter, a supply duct with a flow station feeding terminal HEPA filters, and a suite of corridor, Grade D airlock and Grade C process room with pressure sensors across the doors, with numbered sensor points.123334567corridorGrade D airlockGrade C process room+14 Pa+28 Pasupplyreturn
Air changes in use
25 per hour
Fan input power
10.4 kW
Step Grade C to D
14.2 Pa
Clean-up 100:1
11 min

Anatomy and nameplate

Section through a cleanroom air handler: mixing box with outside and return air dampers, pre-filter, cooling and heating coils, plug fan on a drive and final bag filter, a supply duct with a flow station feeding terminal HEPA filters, and a suite of corridor, Grade D airlock and Grade C process room with pressure sensors across the doors, with numbered sensor points.123334567corridorGrade D airlockGrade C process room+14 Pa+28 Pasupplyreturn
  1. 1Room pressure differentials. One sensor across each door. The step must stay above 10 Pa.
  2. 2Supply airflow. Flow station in the supply duct. Sets the air changes.
  3. 3Filter pressure drop. Pre-filter, final filter and terminal HEPA. Each loads on its own curve.
  4. 4Fan speed and power. From the drive. Power against flow and pressure gives the fan’s efficiency.
  5. 5Coil temperatures. Air on and off the cooling and heating coils. A fouled coil needs colder water for the same air.
  6. 6Humidity. Room humidity against its range. Coils and humidifier hold it.
  7. 7Damper positions. Outside air and return air. A damper that drifts shifts flow and pressure.
Cleanroom air handler nameplate
Air handler
Supply airflow20,000 m³/h (5.56 m³/s)
FanPlug fan, 70% total efficiency, 15 kW motor on a drive
Fan input power, filters at mid-life10.4 kW at 1,178 Pa total
System pressure, filters clean1,000 Pa
Coils and humidityChilled water cooling coil, heating coil, steam humidifier
Ducts, dampers and diffusers470 Pa at design flow
Filters
Pre-filter (ISO ePM10)60 Pa clean, change at 150 Pa, about 4 months
Final filter (ISO ePM1 80%)110 Pa clean, change at 250 Pa, about 12 months
Terminal HEPA (H14)180 Pa clean, change at 360 Pa or on a failed leak test
Suite
RoomsGrade D airlock and Grade C process room, off an unclassified corridor
Volume800 m³
Air changes25 per hour in use
Clean-up 100:111 minutes at 25 air changes, well mixed
Pressure steps13.7 Pa airlock to corridor, 14.2 Pa Grade C to airlock
Offset air160 m³/h from the Grade C room, 50 m³/h from the airlock

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.

WaterSteam and productAirPurified water: Pretreatment, RO and EDIPurifiedwaterRO and EDIWFI still: Makes water for injectionWFI stillMakes WFIHot WFI loop: 80 °C, at least 1 m/s at returnHot WFI loop80 °C, ≥ 1 m/sPoints of use: Formulation, washing and rinsingPoints of useWashing, mixingClean steam: Clean steam generatorClean steamGeneratorSteam sterilizer: Sterilizes parts and equipment for fillingSteamsterilizerFilling partsFreeze dryer: Dries the filled vialsFreeze dryerFilled vialsGMP cold room: 2–8 °C finished stockGMP cold room2–8 °C stockAir handler: Filters, coils and fanAir handlerCoils and fanTerminal HEPA: HEPA filters in the room ceilingsTerminal HEPAIn the ceilingGrade C and B rooms: Pressure steps door to doorGrade C and BroomsPressure steps
  • Water
  • Air
  • Steam
  • Product
  • Has its own twin page

The physics

The equations behind every curve on this page.

Air changes

ACH = 3600·Q / V_room

Air supplied each hour, divided by the size of the room.

Door-gap leakage

Q = Cd·A·√(2·ΔP/ρ)

Offset air leaks out through the gaps around the closed door. The gap and the air set the pressure step.

Fan laws

Q ∝ N ΔP ∝ N² kW ∝ N³

True when every resistance goes with flow squared. Filters do not, so the real saving is smaller.

Fan power

P = Q·ΔP / η

Air moved times the pressure it is pushed against, divided by efficiency.

Clean-up time

t = ln(100) / ACH

How long a well-mixed room takes to clear particles a hundred to one.

Filters and fan power

Every filter adds pressure the fan has to push against. As filters load, the fan works harder for the same air.

Filter pressure drop over two years, with change-outs

At 20,000 m³/h

Filter pressure drop over two years, with change-outs050100150200250300350400024681012141605101520Final filter change at 250 PaMonthsPressure drop (Pa)Fan power (kW)
  • Pre-filter (ISO ePM10)
  • Final filter (ISO ePM1 80%)
  • Terminal HEPA (H14)
  • Fan power (right axis)
Fan power, all filters clean
8.9 kW
Fan power range over two years
8.9–11.3 kW
Each 100 Pa of filter drop
0.86 kW

Filters load slowly, then faster as the dust cake builds. Every pascal of filter drop is fan power, every hour the air handler runs.

ΔP(t) = ΔP_clean·exp(t/τ) | P = Q·ΔP / η

What fewer air changes at rest would save

Empty rooms make far fewer particles. Many plants run fewer air changes when rooms are empty, once QA has approved it and the room still recovers in time.

Fan power against air changes

800 m³ suite, filters at mid-life

Fan power against air changes051015101520253025 ACH in use, 10.4 kW15 ACH at rest, 3.1 kWAir changes per hourFan power (kW)
  • This air handler (filters go with Q, ducts with Q²)
  • Cube law from the design point
Clean-up 100:1 at full air changes
11 min
Clean-up 100:1 at reduced air changes
18 min
Hours a year with rooms empty
4,600 h

Fewer air changes in empty rooms cut fan power by more than half. The cube law overstates it, because filter drop falls only in step with flow.

ACH = 3600·Q / V | P = Q·ΔP(Q) / η | t_100:1 = ln(100) / ACH

The pressure cascade

Air must flow from the cleaner room to the less clean one. Each room pushes its offset air out through the door gaps. The step across each door is the check.

Pressure steps from the corridor into the Grade C room

Each step is the room’s offset air leaking through the closed door

Pressure steps from the corridor into the Grade C room0510152025303502468101214Door to airlockDoor to Grade CCorridorGrade D airlockGrade C roomDistance walked into the suite (m)Room pressure above corridor (Pa)
  • Door gaskets sound
  • Grade C door gasket worn
Step D to corridor
13.7 Pa
Step C to D, sound gasket
14.2 Pa
Step C to D, worn gasket
5.5 Pa

The step goes with the square of offset air over gap area. A worn gasket that opens the gap by 60% takes the step under 10 Pa with the same air.

ΔP = (ρ/2)·(Q / (Cd·A))²

Failure modes

What breaks, what it looks like, what the twin does about it.

Failure modeThe physicsSignals that show itHow the twin catches it
Filter loadingDust builds a cake on the media. Pressure drop climbs slowly, then faster.Filter differential pressure up. Fan speed and power up to hold airflow.Fits each filter to its loading curve and forecasts the change date. Each 100 Pa costs about 0.85 kW at full flow.
Pressure cascade lostA worn door gasket, a drifting damper or extra exhaust changes the leak path or the offset air.Step across a door falls toward 10 Pa. Supply or extract flow changes.Solves for the door gap or offset that explains the step. A gap 60% bigger takes the Grade C step from 14.2 to 5.5 Pa.
Fan belt slip or bearing wearBelt slip lowers fan speed under load. A worn bearing adds friction and vibration.Airflow below the fan law for the motor speed. Power up. Vibration at bearing frequencies.Compares measured airflow with what the fan should move at that speed and pressure.
Humidity out of rangeThe coil or humidifier cannot hold the room against outside air and people.Room humidity at the edge of its range. Coil valve wide open. Humidifier at full output.Runs a moisture balance on the air handler and names the part that has run out of room.
Coil foulingDirt on the fins and scale in the tubes cut heat transfer.Colder water or more flow for the same air temperature. Pressure drop up across the coil.Tracks the coil’s UA from air and water temperatures, and its air-side pressure drop.

What the twin does not do

  • Any change to air changes or room pressures goes through your change control and requalification. We show the savings. QA decides.
  • Your environmental monitoring system stays the record for particles and room pressures. We use its data to find equipment problems.

How we catch it early

A physics twin and a PINN, working on one cleanroom air handler.

The twin is a set of equations for this machine, tuned to its nameplate. Give it the flow, speed and conditions and it returns what every reading should be. It always gives the same answer for the same inputs.

A physics-informed neural network, or PINN, sits on top. It is trained on the plant’s own data and it is penalized whenever it breaks a physics rule. So it can only learn what the equations leave out: wear, fouling, friction. It cannot invent an answer that the machine could never produce.

  1. Step 1

    Measure

    Flow, pressure, current, temperature, vibration. Whatever the asset already has.

  2. Step 2

    Physics twin

    The equations of this machine, set to its nameplate. It says what the readings should be right now.

  3. Step 3

    Residual

    Measured minus expected. Demand, weather and speed are already taken out.

  4. Step 4

    PINN

    A small neural network that learns the cause of the gap, under the physics rules.

  5. Step 5

    Finding

    A named cause, a date, and the kWh or hours at stake. An engineer reviews it.

loss = (measured − predicted)² + λ · (physics residual)²

The second term is the rulebook. It is zero when the network obeys the equations.

Why this beats black-box AI

A black-box model learns patterns from history. It needs examples of each failure, and it goes quiet when the pump runs at a point it has not seen. The twin starts from physics, so it works on day one. The PINN adds what physics cannot know about this particular machine.

That is also what makes the savings countable. The baseline is a calculation, not a guess, so the gap between baseline and meter is a number a customer can check.

What the twin checks on this asset

  • Every pressure step above 10 Pa: now 13.7 and 14.2 Pa
  • Each filter against its loading curve, with a change date
  • Fan power against Q·ΔP/η: 10.4 kW expected at 20,000 m³/h
  • Clean-up time at the air changes in use: 11 min at 25, 18 min at 15
  • Supply airflow against the air-change target for each room
Fixed alarmBlack-box AITwin + PINN
Needs failure history to learnNoYes, lotsNo
Says what is wrongNoRarelyYes, by name
Works at a flow it has never seenNoOften failsYes, the equations still hold
Puts a number on the savingNoNoYes, in kWh and dollars
Lead time on slow wearLateVariesWeeks to months
Every number can be tracedYesNoYes, to an equation

What the twin puts a number on

Energy and cost, from the equations.

15 air changes when rooms are empty

7.3 kW

10.4 kW in use, 3.1 kW at rest. Only if QA approves the change.

Energy per year

33,626 kWh

4,600 empty hours a year (two shifts, five days)

Cost per year

$4,035

Fan power only, at $0.12 per kWh. Less air to cool and heat saves more.

Final filter changed 100 Pa late

7,477 kWh

0.85 kW more for a year, $897

What we do for you

We watch it. We catch it. We prove it.

Our reliability engineers run the twin on your cleanroom air handler, 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.