Bacterial Endotoxin LAL Gel-Clot LAL Kinetic Cytotoxicity Biocompatibility Studies Blood Compatibility The FDA has recognized the LAL Test Method as an official end product Release Test for Bacterial Endotoxins. Transfusion and Infusion Assemblies and similar Medical Devices are tested to comply wit...

Sterility Bioburden Sterilization Validations Environmental Monitoring Package Integrity Consulting Services Bioburden testing is designed to enumerate viable populations of naturally occurring microorganisms on product samples. Devices are tested by employing one of two basic techniques. Validation...

OUR MISSION STATEMENT TO PROVIDE PERSONALIZED, CUSTOMER AND TECHNICAL TESTING SERVICES IN A PROFESSIONAL, ACCURATE AND INDEPENDENT MANNER. TO CONTINUALLY IMPROVE OUR QUALITY MANAGEMENT SYSTEMS BY SETTING QUALITY OBJECTIVES, CONDUCTING REGULAR QUALITY REVIEWS, EMPLOYEE TRAINING AND OBTAINING CUSTOMER...

Sterility Bioburden Sterilization Validations Environmental Monitoring Package Integrity Consulting Services ETHYLENE OXIDE STERILIZATION VALIDATION PROGRAMS This suggested validation-testing program follows the guidelines contained in the ANSI/AAMI/ISO 11135:1994 standard. This international recogn...

Bacterial Endotoxin LAL Gel-Clot LAL Kinetic Cytotoxicity Biocompatibility Studies Blood Compatibility Various Cytotoxicity Tests are available to characterize Medical Device components or materials. These In-Vitro test methods are an easy and economical tool in assessing candidate new materials as ...