Understanding the difference between cleanroom certification and cleanroom validation.

10:44 - 27/08/2025 158

Each serves a different purpose in ensuring your controlled environment performs as required, and both are important for meeting compliance expectations.

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☰ Table of Contents

1. Clearly understanding the difference between cleanroom qualification and validation
1.1. The core differences in scope and objectives
1.2. When should each step be performed?
1.3. Main phases of cleanroom qualification
1.4. Specific tests included in qualification
1.5. How does validation take place?
1.6. Visual comparison: Qualification vs Validation
2. Practical takeaways

Clearly understanding the difference between cleanroom qualification and validation

1. The core differences in scope and objectives

Qualification focuses on checking whether the cleanroom operates correctly according to its engineering design.

Validation verifies whether the cleanroom, as part of the operating process, regularly and consistently achieves the required performance and intended outcomes.

Missing either aspect can lead to non-compliance: a cleanroom may pass qualification but still fail validation if operator workflows, SOPs, or environmental controls are not sufficiently stringent.

2. When should each step be performed?

Cleanroom qualification should be implemented in the following cases:

After a new cleanroom has been installed.
When major renovations or significant changes are made.
Periodically (often annually) to ensure ongoing performance.

Validation should be carried out in cases such as:

When introducing a new product or a new process.
After updating SOPs, work practices, or equipment.
According to GMP guidance, often before commercial release.

3. Main phases of cleanroom qualification

Depending on standards such as GMP or ISO, qualification typically includes three steps:

IQ – Installation Qualification: Ensures equipment and systems are installed correctly and match the design.
OQ – Operational Qualification: Confirms equipment and systems operate according to specifications.
PQ – Performance Qualification: Verifies the cleanroom can operate continuously and meet required environmental quality conditions under dynamic (in-operation) conditions.

4. Specific tests included in qualification

Some standard baseline tests include:

Airborne particle counting.
Filter integrity testing.
Air velocity and airflow volume measurements.
Differential pressure measurements between areas.
Airflow visualisation (smoke studies).
Surface microbiological control, temperature, and humidity control.
Recovery testing (clean-up/recovery after contamination).

5. How does validation take place?

Validation focuses on the overall performance of the cleanroom within the manufacturing process—ensuring all factors comply, such as:

Cleanroom gowning procedures.
Environmental particle monitoring.
Cleaning and disinfection procedures.

6. Visual comparison: Qualification vs Validation

Aspect	Qualification	Validation
Objective	Ensure the cleanroom is built and operates according to design	Assess consistency in supporting the manufacturing process
Scope	Room structure, HVAC system, equipment, utilities	Operating environment, procedures, people, behaviors
Key question	“Has the cleanroom been designed and does it operate correctly?”	“Does the cleanroom maintain performance in real production?”
Typical checks	IQ, OQ, PQ, technical environmental tests	Cleaning-process follow-up, environmental monitoring, personnel behavior

Practical takeaways

Qualification and validation are two essential components to ensure a cleanroom meets technical standards and operates stably and effectively within a manufacturing process. While qualification checks the structure and systems, validation ensures everything—from gowning and procedures to the environment—meets requirements in real operation. Failing to distinguish clearly between them, or skipping any stage, can create compliance risks. Maintaining both in parallel is key to meeting GMP requirements and ensuring product quality.