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ISO 14644 / GMP Annex 1

How to plan differential pressure monitoring in a cleanroom

Differential pressure keeps contamination out of the cleanroom by holding clean zones at a slight overpressure against less clean ones. This guide covers setpoints, building a pressure cascade, sensor selection and alarming per ISO 14644 and GMP Annex 1.

5 minStand: 2026-07Geprüft: Technical editors
View cleanroom equipment
10-15 Pa
typical step per airlock
≥ 5 Pa
minimum GMP Annex 1
±1 Pa
recommended sensor accuracy
Annex 1
continuous logging required
Inhalt
  1. Basics and setpoints
  2. Planning the cascade
  3. Sensor choice
  4. Alarming and records
  5. Frequently asked questions

Why does a cleanroom need differential pressure?

Differential pressure is the controlled pressure difference between two adjacent zones. When the cleaner room sits at overpressure, air always flows from clean to less clean and carries particles out of the critical zone. Without this staggering, contamination could enter every time a door opens.

GMP Annex 1 targets a pressure difference of 10 to 15 Pa between consecutive grades, with roughly 5 Pa as a minimum. ISO 14644‑4 gives similar figures for adjacent zones and requires a documented design of the airflow direction.

When handling hazardous or sterile products, a deliberate negative pressure (containment) may be preferable to overpressure. The flow direction always follows the protection goal: protect the product or protect the environment.
Cleanroom classes

How ISO 14644-1 defines particle classes ISO 1 to ISO 9.

Read the guide

How do you build a pressure cascade?

A pressure cascade stages the rooms from the highest to the lowest cleanliness grade. Every airlock and transition gets a defined pressure step, so the pressure decreases continuously from the production zone out to the surroundings.

  • Fix a reference point: usually the unregulated corridor or ambient at 0 Pa.
  • Step the pressure down consistently from inside out, without skipping a level.
  • Use airlocks as buffers so opening a door does not reverse the airflow.
  • Balance supply and exhaust per room so the setpoint stays stable.
Design door interlocks so that both doors of an airlock are never open at once. Otherwise the pressure cascade briefly collapses.

Which sensors and measuring points are right?

Differential pressure transmitters connect two rooms via short tubes. Cleanrooms suit sensors with a range of about 0 to 60 Pa and an accuracy of around ±1 Pa, so small setpoints are resolved reliably.

  • Place the measuring point in a calm spot, not next to a supply diffuser or door.
  • Route the reference port to the neighbouring zone, keep tubes short and kink-free.
  • Calibrate sensors regularly and log every check.
  • Add a local display so staff can read the pressure at any time.
For critical GMP areas an independent monitoring chain in addition to the control loop is advisable, so a single sensor fault does not blind both control and alarm at once.

How do you set limits and alarms?

GMP Annex 1 requires continuous monitoring of differential pressure with recording and alarming. A two-stage concept works well: a warning threshold before the tolerance band is left, and an alarm when the critical minimum is undershot.

  • Warning: pressure approaches the tolerance limit, e.g. below 8 Pa at a 12 Pa setpoint.
  • Alarm: minimum pressure undershot or flow reversal, e.g. below 5 Pa.
  • Add a few seconds of delay to avoid false alarms when doors open.
  • Send alarms to the control system and staff, log acknowledgement and cause.
Record measured values without gaps. For GMP areas, trends, limit violations and corrective actions must be stored in a traceable, audit-proof way.
Monitoring systems

Matching differential pressure transmitters and displays for your zones.

Read the guide

Frequently asked questions

What differential pressure applies between two cleanroom zones?

GMP Annex 1 targets 10 to 15 Pa between consecutive grades, with about 5 Pa as a minimum. The exact setpoint depends on the process and the protection goal.

Overpressure or negative pressure?

Overpressure protects the product by pushing air outward. For hazardous or toxic substances a deliberate negative pressure is used so nothing escapes into the environment (containment).

How accurate must a differential pressure sensor be?

For typical steps of 10 to 15 Pa the accuracy should be around ±1 Pa. A range of 0 to 60 Pa suits most transitions and airlocks.

What does GMP Annex 1 require for monitoring?

Continuous measurement and recording of differential pressure with alarming on limit violation. The data must be documented and evaluated in an audit-proof manner.

Planning differential pressure monitoring?

We supply differential pressure transmitters, displays and alarming for cleanrooms per ISO 14644 and GMP Annex 1 - from the airlock to the core zone.

Standard-compliant

Design per ISO 14644 and GMP Annex 1.

Precise measurement

Transmitters with ±1 Pa and stable zero.

Complete records

Continuous logging and alarming.

Expert advice

Support with cascade and sensor choice.

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