CLEANROOM TESTING AND VALIDATION SERVICES

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!

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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.

Cleanroom Standards

Every industry and product require different standards:

  • FED STD 209E Standard
  • ISO 14644-1 Standard
  • GMP Standard
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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 in various fields such as food, pharmaceuticals, operating rooms, cosmetics, electronic component manufacturing plants…. These rooms need to be regularly checked to ensure maximum accuracy during operation and product manufacturing. Cleanroom testing will include the following factors:

CLEANROOMS ARE TYPICALLY CERTIFIED BY

vilas-logo

VILAS is the system for recognizing testing and calibration laboratories in Vietnam. It is one of the recognition programs of the Bureau of Accreditation Vietnam (BoA), which is a member of the Mutual Recognition Arrangement (MRA) of regional and international accreditation organizations such as APLAC and ILAC, participating in activities within ILAC, APLAC, and PAC.

VILAS was officially established by Decision No. 1962/QD-TCCBKH signed by the Minister of the Ministry of Science, Technology, and Environment on April 10, 1995.

Currently, VILAS recognizes the following fields: Mechanical, Chemical, Biological, Pharmaceuticals, Electrical-Electronics, Building Materials, Non-Destructive, Measurement and Calibration, and Biological Safety.

NEBB LOGO

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.

INTECH Service
Specializing in providing accurate and high-quality cleanroom testing and validation services certified by NEBB.

Chung nhan NEBB INTECH SERVICE

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

  • Checking air flow rate and velocity.
  • Testing HEPA/ULPA filter leakage.
  • Checking room pressure.
  • Checking recovery capability.
  • Checking air particle concentration and size.
  • Checking relative humidity.
  • Checking temperature.
  • Conducting various other testing conditions..

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.
  • Certification globally issued by INSTI and TECHNICAIR Singapore.

STAGES OF CLEANROOM ASSESSMENT ACCORDING TO NEBB

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.

Strategic Partner of INTECH Service

TechnicAir Group is a company certified by the National Environmental Balancing Bureau (N.E.B.B.) for cleanroom performance testing and NSF-certified for Class II biological safety cabinet certification. Our certified technical experts have over 20 years of experience in the cleanroom industry, with our technicians regularly trained and updated on all the latest international standards to meet customer requirements and satisfaction.

TechnicAir Group holds reputable NEBB certifications for various sectors, including Pharmaceuticals, Hospitals, Semiconductors, Healthcare, Electronics Industry, Medical Equipment Cleanrooms, Medical Cleanrooms, Aerospace, Biological Safety Research Facilities, CDC BIBO Systems, Precision Technical Cleanrooms, Animal Research Facilities, and Food Processing and Packaging.

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TYPICAL PROJECTS

INTECH Service takes pride in being the chosen partner for cleanroom testing and validation by various investors.

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