Is differential pressure gauge required in ISO 7 clean room?

In cleanroom systems, especially ISO 7 cleanrooms, maintaining stable pressure between areas is a key factor to prevent cross-contamination and ensure cleanliness according to ISO 14644 standards. Therefore, whether a differential pressure gauge is necessary in an ISO 7 cleanroom is a question of interest to many businesses. This device not only helps monitor and maintain pressure differences but is also a mandatory tool in the process of appraisal, calibration and quality control of pharmaceutical, food and cosmetic factories.

1. Is a differential pressure gauge necessary in an ISO 7 cleanroom?

Yes. In ISO 7 cleanrooms, differential pressure gauges are considered essential for monitoring pressure differences between areas with different cleanliness classifications.

This device helps to:

• Maintain unidirectional airflow
• Prevent air contamination from less clean zones
• Ensure compliance with ISO 14644 and GMP operational standards

Beyond real-time monitoring, differential pressure gauges serve as critical reference tools in the assessment, calibration, and validation processes of cleanrooms-particularly in pharmaceutical, cosmetic, and food manufacturing environments that require stringent contamination control.

2. Why must pressure differentials be controlled in ISO 7 cleanrooms?

ISO 7 cleanrooms often act as transitional zones between higher-grade areas (ISO 5-6) and lower-grade zones (ISO 8-9). Therefore, pressure differential control is mandatory to maintain proper airflow direction.

1. Zoning and airflow control

• ISO 7 cleanrooms are usually designed with airlocks or buffer zones
• Maintaining higher pressure relative to adjacent areas pushes air outward, minimizing particle or microbial ingress

2. Preventing cross-contamination

• Pressure differentials prevent contaminated air from infiltrating critical production zones
• Especially important in weighing rooms, compounding areas, and packaging sections

3. Compliance with ISO 14644 requirements

• ISO 14644 mandates a minimum pressure differential of ≥10 Pa between areas of differing cleanliness
• This is a key metric in cleanroom qualification, especially under GMP, HACCP, and ISO 22716 frameworks

See more: Provider of Differential Pressure Gauges for Electronic Component Manufacturing Cleanrooms

3. The role of differential pressure gauges in daily operations

In tightly controlled environments like ISO 7 cleanrooms, differential pressure gauges function not only as measurement tools but as critical monitoring instruments.

1. Real-time pressure status monitoring

• Staff can directly observe gauges installed at airlocks, weighing rooms, or gradient corridors
• Imbalance in pressure can be immediately detected and addressed before it disrupts operations

2. Early detection of technical issues
A sudden pressure drop may indicate:

• Door seal leakage
• Clogged HEPA filters
• HVAC system instability

With a differential pressure gauge in place, technicians can promptly identify and resolve such issues.

3. Audit and data traceability

• Pressure differential readings are mandatory records in GMP and ISO 14644 audits
• Many gauge models support data logging or signal output to BMS, enabling seamless traceability

No differential pressure gauge = No real-time control = High risk of audit failure and process deviations.

4. Key criteria for selecting a differential pressure gauge for ISO 7 cleanrooms

Not all gauges are suitable for cleanroom environments. Below are essential technical criteria to consider:

Recommendation: For ISO 7 cleanrooms, dual-needle differential pressure gauges are ideal for instantly comparing adjacent zones-no need for complex electronic sensors.

See more: Latest price list of Differential pressure gauge used in Cosmetic factory

5. Recommended installation points for differential pressure gauges in ISO 7 cleanrooms

Proper installation of differential pressure gauges is essential for effective monitoring in cleanroom systems. Below are key areas where gauges are required or highly recommended:

1. Airlocks between cleanroom classifications

• Commonly installed between ISO 7 and ISO 8 or ISO 6 rooms
• Ensures unidirectional airflow from cleaner to less clean areas
• Detects early signs of pressure reversal, which can compromise cleanliness

2. Weighing rooms - changing rooms - compounding areas

• High-risk zones for cross-contamination, requiring continuous pressure monitoring
• Weighing rooms often require lower pressure to prevent powder dispersion, making accurate differential monitoring essential

3. Interlock doors and gradient corridors

• Should be placed near interlocked doors for easy visibility by operators
• Transition zones between different cleanliness levels also require pressure monitoring

Technical tip: Mount gauges at eye level and away from door gaps or airflow currents that could distort readings.

6. Consequences of lacking a differential pressure gauge in ISO 7 cleanrooms

Overlooking this seemingly minor device can result in major operational and compliance risks:

1. Inability to detect pressure imbalance

• Without gauges, staff cannot determine if pressure drops or reverses between zones
• Dirty air may enter cleaner zones, impacting product safety and quality

2. Increased risk of cross-contamination

• Microbes, fine dust, or chemical vapors from lower-grade areas may infiltrate ISO 7 zones
• Particularly hazardous in pharmaceutical, food, and cosmetic production environments

3. Failure in GMP or ISO qualification audits

• Standards such as ISO 14644, EU-GMP, and WHO-GMP require active differential pressure monitoring
• No gauge = no control evidence = audit failure = potential system redesign required

Conclusion: Missing a differential pressure gauge is not a minor oversight-it's a serious breach in cleanroom quality control systems.

See more: A Guide to Differential Pressure Gauge Calibration

7. Frequently Asked Questions

1. Does ISO 7 require a specific pressure differential?

Yes. According to ISO 14644 and GMP guidelines, ISO 7 cleanrooms must maintain a differential of 10-15 Pascal above adjacent lower-grade areas. This ensures unidirectional airflow to prevent contamination.

2. Can electronic pressure sensors replace analog gauges?

Yes. Electronic sensors are ideal for integration into BMS or SCADA systems, allowing for remote monitoring and data logging.
However, in smaller facilities or areas without automation needs, analog gauges remain popular due to:

• Easy on-site visibility
• Low cost
• No power requirement

3. How often should differential pressure gauges be calibrated?

At least once every 6-12 months, or according to internal GMP protocols. Regular calibration ensures:

• Accurate measurements
• Audit-ready data records
• Prevention of errors due to prolonged drift

8. Are you designing or operating an ISO 7 cleanroom?

In every ISO 7-compliant cleanroom system, a differential pressure gauge is not just a measuring tool-it’s a critical safety control point.

If you are:

• Building a weighing room, airlock, or gowning area requiring pressure monitoring
• Preparing for a GMP or ISO audit and need verifiable data
• Planning to integrate BMS or SCADA for remote monitoring

→ Then it's time to invest in the right gauge - with the right specifications.

Differential Pressure Gauges from VCR

Model Options:

• Dual-needle analog gauges, digital (electronic) gauges
• Common ranges: 0-60 Pa, 0-250 Pa

Advanced Features:

• High accuracy: ±1-2% F.S
• Optional pressure alarms, 4-20 mA or RS485 signal outputs
• Cleanroom-compatible materials and sealed housings

Full Compliance:

• Provided with CO-CQ and calibration certificates
• Support for installation and system integration

VCR’s team will help you select the most suitable device based on your cleanroom layout and compliance with GMP and ISO 14644 standards.

Hotline: 090.123.9008

Email: [email protected]

Website: https://donghochenhap.com/

Diep VCR