NEBB Cleanroom Performance Testing Service

Cleanroom testing or validation is an essential activity for any factory or manufacturing facility that has constructed and installed cleanrooms. This task aims to identify and evaluate whether the cleanliness level in the room meets current standard requirements. So what exactly does cleanroom testing contain? Let’s explore this topic together in this article!

Why is it necessary to regularly test and validate cleanrooms?

Cleanrooms are one of the conditions necessary for manufacturing facilities to achieve ISO or GMP standards. During the operation of cleanrooms, regular testing and validation are required for the following reasons:

•Avoiding unwanted incidents
•Ensuring that cleanrooms consistently meet standards
•Upgrading cleanrooms to new standards
•Demonstrating to customers that the production line within the cleanroom meets standards
•Avoiding the impact on production results due to cleanroom long-term lack of maintenance and downgrading of validation
•Equipment in cleanrooms, during operation, may malfunction without knowing whether it affects cleanroom standards or not

IMPORTANT FACTORS IN CLEANROOMS

Cleanrooms are not a new concept for manufacturing companies or factories, hospitals – places that require high cleanliness levels to ensure hygiene and avoid affecting the quality of products. Cleanroom testing will include the following factors:

Airborne Particle Limits

The limit of airborne particles in the air depends on the different cleanroom classifications.

Humidity

The humidity requirement for cleanrooms meeting the standard usually falls within the range of 50 – 60%

Temperature

Typically, the required temperature for cleanrooms will range from 20 – 26 degrees Celsius.

Microbial Limits

Microbial limits also depend on the cleanroom classification, similar to airborne particle limits.

Cross-Contamination

Special attention is needed to prevent cross-contamination when constructing cleanrooms.

Differential Pressure Between Rooms

Differential pressure between rooms is monitored using pressure gauges installed in each room to check the stability of pressure within the room. The pressure difference between two rooms with different cleanroom classifications is typically 10 – 15 Pa.

CLEANROOMS ARE TYPICALLY CERTIFIED BY

The National Environmental Balancing Bureau (NEBB) was established in 1971 in the United States. It is an organization that provides international certifications for operation, monitoring, particularly in high-tech engineering fields, notably cleanroom testing NEBB Certification. Currently, NEBB has headquarters and offices in various countries worldwide such as South Korea, the UK, Malaysia, Singapore, etc.

NEBB typically provides, establishes, and maintains standards, procedures, and technical specifications to guide necessary work and confirm knowledge for accredited units. When obtaining NEBB certification, it demonstrates that the unit has the necessary conditions, methods, procedures, knowledgeable personnel, and accurately calibrated equipment to produce cleanroom assessment reports according to specified standards.

TECHNICAIR SERVICE SPECIALIZING IN PROVIDING ACCURATE AND HIGH-QUALITY CLEANROOM TESTING AND VALIDATION SERVICES CERTIFIED BY NEBB.

REQUIREMENTS TO OBTAIN NEBB CERTIFICATION

The company must have been in operation for at least 12 months and must be a technical company, mechanical contractor, plumbing contractor, fire protection contractor, electrical contractor, testing contractor, or a testing, adjusting, and balancing (TAB) contractor.
Obtain six letters of endorsement from building owners or agencies in the area regarding the company’s reputation and responsibility.
Possess the necessary Cleanroom Performance Testing (CPT) tools required for NEBB certification in cleanroom performance testing.
Have current NEBB standards for testing cleanroom performance.
The document appointing an expert, who has obtained NEBB certification, will serve as the company’s representative and be responsible for supervising cleanroom assessment according to NEBB Certification
Be a reputable member of the local NEBB.

TESTS DURING CLEANROOM VALIDATION ACCORDING TO NEBB

HEPA filter installation leakage test

Airborne particle count test

Air velocity and airflow uniformity test

Temperature test

Humidity test

Illuminance test

Sound level test

Room pressure test

Airborne bacteria count test

Air changes per hour (ACH) calculation test

SUPERIOR BENEFITS OF NEBB

All services performed using equipment calibrated and certified according to international standards.
Leading certification in cleanroom quality assessment, recognized by countries worldwide for exporting products internationally.
Certified globally by TECHNICAIR Singapore.

ASSESSMENT STAGES

Installation Assessment

Cleanroom assessment under NEBB Certification is conducted to inspect connections before equipment, manufacturing materials, and staff are present, ensuring accurate installations.

Operational Assessment

Performed after installing equipment but before staff perform duties in the cleanroom. This test in NEBB cleanroom assessment ensures the operational performance of equipment as per the original design.

Performance Assessment

Tests are conducted and evaluated when all equipment is operational, and staff are directly working. Cleanroom assessment according to NEBB Certification in this stage demonstrates that the cleanroom operates effectively to meet the organization’s intended purposes.