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Jason@cleanroomequips.comCleanroom Certification
Cleanroom certification is a systematic process used to validate that a cleanroom meets specific cleanliness and environmental control standards. This certification is essential in industries where contamination control is critical, such as pharmaceuticals, biotechnology, semiconductor manufacturing, and aerospace.
Cleanroom certification involves several steps to ensure that a cleanroom operates within defined limits for particulate contamination, temperature, humidity, and pressure differentials. The objective is to confirm that the cleanroom environment meets the requirements set out by industry standards and regulations.
Deiiang - Your Expert in Cleanroom Testing and Certification in China.
We have over 20 years of experience in building, testing and certifying cleanrooms.
Call Peng (+86 18186671616) or send an email to Pengwu1616@Gmail.com to arrange your certification.
Your Reliable Manufacturer of Cleanroom Certification
Certification standards
ISO 14644:
This is the primary international standard for cleanrooms and controlled environments.
It classifies cleanrooms based on the maximum allowable particle counts per cubic meter of air, categorizing them into ISO Classes ranging from ISO Class 1 (the cleanest) to ISO Class 9.
Good Manufacturing Practices (GMP):
These guidelines are particularly important in the pharmaceutical and food industries, ensuring that products are consistently produced and controlled according to quality standards.
Federal Standard 209E:
Although this standard has been superseded by ISO 14644, it is sometimes referenced in the cleanroom context, particularly in the United States.
iso_cleanroom_standards_and_federal_standard_209e.pdfFDA Regulations:
The U.S. Food and Drug Administration has specific requirements for cleanrooms in pharmaceutical and medical device manufacturing.
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Testing and Evaluation
Airborne Particulate Testing
Airflow and Pressure Testing
Temperature and Humidity Monitoring
Airborne bacteria test
Optional Certification (must be requested at time of quote)
Temperature map
Humidity map
Individual HEPA FFU air flow with Velgrid
Lighting intensity map (foot-candles at 3’ AFF)
Sound map (decibels)
Our Equipment
Shortridge 860C Air Data manometer with Velgrid for individual hepafilter flow measurement
Hach 3413 particle counter
Met One BT 637 particle counter with temperature and humidity
Tondaj LX1010B digital light meter
Climet 150T laser particle counte
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- Video
- Workshop
- Data sheet
- Certificate
Related Products
Help to Find Your Cleanroom Related Products
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Modular CleanRoom
US$9000-10000 USD/Unit
Min. Order:1 unit -
Air Shower
US$1000.00-5000.00 USD/Unit
Min. Order:1 unit -
Downflow Booth
US$3000-6000 USD/Unit
Min. Order:1 unit -
Clean bench
US$600-2000 USD/Unit
Min. Order:1 unit -
Air Filter
US$3-50 USD/Unit
Min. Order:1 unit -
Cleanroom Wall Panels
US$10-20 USD/sq.
Min. Order:100 square -
Pass Box
US$200-500 USD/Unit
Min. Order:1 unit -
FFU
US$135-350 USD/Unit
Min. Order:1 unit
Cleanroom Certification Video Introduction
FAQ
Q:What is clean room certification?
A:Cleanroom certification is the process of validating that a cleanroom meets specific cleanliness standards and operational requirements for controlling contamination.
Q:How often must a clean room be certified?
A:The frequency of cleanroom certification can vary based on several factors, including industry standards, regulatory requirements, and the specific operational practices of the facility.
Q:What are the requirements for a cleanroom?
A:The requirements for a cleanroom are defined by various standards and guidelines, with the primary goal of controlling contamination to ensure a controlled environment suitable for sensitive processes.
Q:Is ISO 5 cleaner than lSO 7?
A:Yes, ISO Class 5 is cleaner than ISO Class 7. The ISO 14644 standard classifies cleanrooms based on the maximum allowable number of particles per cubic meter of air, specifically focusing on particles of 0.5 micrometers (µm) in size and larger.
Q:how to achievecleanroom validation &certification
A:Achieving cleanroom validation and certification involves a systematic process that ensures a cleanroom meets specific cleanliness standards and operational requirements.
Q:Do cleanrooms need to be certified?
A:Yes, cleanrooms typically need to be certified to ensure they meet specific cleanliness and operational standards required for their intended applications.
Q:What is the qualification of cleanrooms?
A:Cleanroom qualification in the Good Manufacturing Practice (GMP) industry, particularly within pharmaceuticals, is a critical process designed to ensure that these specialized environments meet stringent regulatory standards and guidelines for cleanliness and controlled conditions.
Q:What are the requirements for lSO 8 cleanroom certification?
A:0.5 µm and larger: Maximum of 3,520,000 particles per cubic meter.
5.0 µm and larger: Maximum of 832,000 particles per cubic meter.
