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MENUCleanroom 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.
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Although this standard has been superseded by ISO 14644, it is sometimes referenced in the cleanroom context, particularly in the United States.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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FAQ
Q:What is clean room certification?
A:Cleanroom certification is basically the process of determining whether a cleanroom meets the cleanliness and operational requirements that are necessary to control contamination.
Q:How often must a clean room be certified?
A:The frequency of cleanroom certification depends on many factors, such as industry standards, regulations, and the operational practices of the cleanroom.
Q:What are the requirements for a cleanroom?
A:The requirements according to standards and regulations of cleanrooms are aimed at controlling contamination and providing an appropriate environment for specific processes.
Q:Is ISO 5 cleaner than lSO 7?
A:Yes, ISO Class 5 is cleaner than ISO Class 7 as measured by ISO Standard 14644 for cleanrooms, which sets a maximum number of particles allowable in one cubic meter of air starting from 0.5 micrometer (µm) in size.
Q:How can cleanrooms be certified and validated?
A:Certification and validation of cleanrooms involves following a methodical process to confirm the cleanroom's conformance to the necessary cleanliness levels and operational parameters.
Q:Do all cleanrooms require certification?
A:Yes, cleanrooms need to be certified regularly to make certain their cleanliness and operational standards comply with regulations needed in relation to their use.
Q:What does cleanroom qualification mean?
A:Cleanroom qualification within the Good Manufacturing Practice (GMP) is an essential component that involves meeting strict requirements and legislation with regard to cleanliness and operation of the cleanroom.
Q:What does ISO 8 cleanroom certification require?
A:All cleanrooms are required to adhere to the following ISO 8 cleanroom certification requirements:
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
