Home About Us Contact Us Consumables Location Affiliations
LAL Testing

 "Limulus Amebocyte Lysate" or LAL is an extract from the blood cells of the horseshoe crab that reacts when it comes into contact with endotoxins. LAL is performed for the purpose of identifying the pyrogen levels of medical devices in accordance with the United States Pharmacopoeia Guidelines.


The Food and Drug Administration requires that the bacterial endotoxin levels be determined prior to the sale of any device that is labeled "Pyrogen Free."  Pyrogen levels are established to determine if the product is safe for its intended use.

LAL testing is performed in various ways. Dynatec uses in-vitro methods when conducting LAL testing, such as:
  • Gel-Clot Method: A pass/fail method that determines a threshold of endotoxins in a medical device. It can be used for product release.
  • Kinetics Methods: Two methods, Turbidimetric and Chromogenic, that can determine a specific amount of endotoxins in a sample.
Other applications for LAL:
  • LAL is used to detect endotoxin levels in processed water and biological solutions.
  • Biocompatibility studies for new products, revised manufacturing processes, and R&D processes.
Dynatec's staff is available to assist you with your LAL Analysis needs.
Call 915-849-1322 (ext. 111) or email us.


Click Here to Request LAL Testing
News
Dynatec is now ACLASS Accredited to ISO 17025: 2005 #AT-1372

Click here to view certificate
 
FDA Registration #1645333

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