What is a cleanroom?

Cleanroom is a place where the amount of dust and microorganisms in the air is limited to the lowest level to avoid contamination of components, equipment, and products during the manufacturing and production process.

Cleanroom: room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room.

For a range of uses, cleanrooms are made to regulate the atmosphere and airborne particulates. Due to the capacity of microorganisms to proliferate under favorable conditions and to cause serious injury when contaminated products or preparations are ingested or injected, monitoring of live particles in cleanrooms for pharmaceutical manufacture and compounding requires specific care.

Why is cleanroom assessment necessary?

Assessing cleanroom quality helps businesses:

• Control risks of product and production process contamination
• Meet the requirements of international standards and certifications
• Ensure stable cleanroom operating conditions
• Support cleanroom validation and re-validation activities
• Enhance product quality and production efficiency

Standards related to cleanroom

Environmental Consultancy & Sustainability Services at Eurofins Environment Testing in Vietnam offers cleanroom assessment services in accordance with various international standards and guidelines, including:

• US Federal Standard STD STD 209E
• International standards: ISO 14644-1 and GMP Standards (GMP EU, GMP WHO, cGMP).

Factors when controlling cleanroom quality

• Cleanliness classification according to ISO 14644-1
• Airborne particle counting
• Cleanroom environmental microbiology assessment
• Temperature and humidity assessment
• Pressure differential assessment between areas
• Ventilation and air filtration system assessment
• Airflow and air velocity assessment
• Cleanroom operating condition assessment
• Consultancy on improving and maintaining cleanroom quality

Cleanroom quality assessment services

Backed by a team of experienced experts and independent testing and assessment capabilities, Environmental Consultancy & Sustainability Services at Eurofins Environment Testing in Vietnam provides cleanroom quality assessment and survey programs tailored to the specific needs of each business.

Assessment results help businesses determine the level of cleanroom compliance, identify areas for improvement, and develop appropriate control plans to maintain a stable production environment and meet technical requirements.

The assessment reports are comprehensive and clear, effectively supporting internal audits, customer assessments, or third-party certification processes.