Home About Us Contact Us Consumables Location Affiliations
Cleanroom Analysis

A Clean Room is defined as a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. In addition, the concentration of microorganisms in the environment is monitored; each cleanliness class defined is also assigned a microbial level for air, surface, and personal gear (United States Pharmacopoeia Guidelines).
 
A Clean Room should have, as a minimum design specification, the following:
  • Designed specification that identifies the operating parameters of the Clean Room, Gowning Room, and H-VAC System(s)
  • Facility floor plans for manufacturing processes that include raw materials, finished products, packaging, and operational equipment
  • Facility floor plans for indirect processes that include air pressure lines, water lines, conveyor systems, heat sealers, etc.
  •  

A Clean Room or controlled environment will perform under dynamic conditions. Those attributes should be monitored and statistically evaluated to understand the efficacy and standardize your specific alert and action limits.

References:
  • Institute of Environmental Sciences
  • U.S. Pharmacopeia Guidelines
  • ISO 14644
  • ISO 14698
  • ISO 8573 
Key factors in controlling contamination:
  • Personnel
  • Apparel
  • Equipment
Indirect Processes
  • Training
  • HEPA (High Efficiency Particulate Air)
  • Differential Pressure
  • Laboratory knowledge in Clean Room monitoring
  • Compressed Air  
Dynatec can certify your clean room, conduct investigations, or develop monitoring programs.
Call 915-849-1322 (ext. 111) or email us.




Click Here to Request Cleanroom Analysis Services
NEWS
Dynatec is now ACLASS Accredited to ISO 17025: 2005 #AT-1372

FDA Registration #1645333 
Click here to view certificate

ACLASS 

Dynatec third party lab for air compressor certification to ISO 8573 via TUV America. TUV AMERICA



Updates
Controlled Environments Magazine  

Article, Medical Device Manufacturing of U.S Products in Mexico, Vol.12 No.4 in Controlled Environments Magazine

Click here to view

ANSI/AAMI/ISO 10993-7:2008
New Standard Biological Evaluation of Medicine-Part 7:Ethylene Oxide Sterilization Residuals Standard has been published. Any questions regarding the new Tolerable Contact Limit (TLC) please call Dynatec Labs at (915)849-1322 or view AAMI website.



For your convenience, please see our online "Request for Testing Services Form" located at the bottom of each "Our Services" section