Dynatec Labs - The Answer To Market Advantage_Steriliry

Sterility Assurance

Definition: Test performed to establish the presence or absence of viable microorganisms on product units, or portions thereof, when subjected to defined culture conditions (AAMI/ISO TIR 15844:1998).

Who Should Test: Medical Device Manufacturers, Pharmaceutical, Cosmetic Industry. Dynatec will help you evaluate your product and recommend the testing your product should be tested for.

Dynatec offers sterilization qualification services in accordance to standards below:

U.S. Pharmacopeal Gudelines
Testing compliance based on ANSI/AAMI/ISO 11137/TIR27

Methods of Sterilization:

Radiation Sterlization
VDmax Sterilization Method
Ethylene Oxide Sterilization
Steam Sterlization
Dry Heat /Moist Heat

Test Compliance for:

Radiation Sterilization Qualification- Road map to test specification: a Master Specification is developed and it includes a sample item portion (SIP) preparation, bacteriostasis/fungistasis (B/F) studies, recovery of microorganisms, bioburden studies, steriltiy testing. Final approval of client.
VDmax Sterilization Qualification
Ethylene Oxide Sterilization Qualification
Steam Sterilization Sterilization Qualification
Dry Heat/ Moist Heat Sterilization Qualification

Dynatec's staff is available to assist you with your Sterility Assurance needs.
Call 915-849-1322 (ext. 111) or email us.

Click Here to Request Sterility Assurance Services

News
Dynatec is now ACLASS Accredited to ISO 17025: 2005 #AT-1372

FDA Registration #1645333

Click here to view certificate

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

Updates

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

Click here to v iew

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