February 18, 2025
Hayden Rowan
Medical Device Testing, Pharmaceutical Testing, Lot Release Testing, Turnaround Times
Sterility Assurance, USP <71> Bioburden Determinations, ISO 11737-1, Microbial Limits, USP <61>, USP <62>, Bacterial Endotoxin Testing, Limulus Amebocyte Lysate, LAL, USP <85>, AAMI ST72
At LexaMed, we understand that time is critical. That’s why we pride ourselves on delivering the fastest turnaround times in the industry. Whether it’s sterility, bioburden, or endotoxin testing, we consistently exceed industry standards, ensuring you get the results you need – when you need them. With our advanced technology and expert team, we make speed and accuracy our priority, helping you make quick, informed decisions. Choose LexaMed for all routine testing that works at your pace!
LexaMed’s in-house microbiology and chemistry services ensure independent confirmation of test results that are completed with the highest quality and most expeditious manner. LexaMed understands how important lot release testing is to getting your product to the market and we pride ourselves with our turnaround times.
Sterility testing is critical for pharmaceuticals and medical devices that claim to be sterile or free from viable microorganisms. At LexaMed, we conduct rigorous sterility tests to verify the absence of bacteria, fungi, and other pathogens, ensuring your products meet the highest safety and regulatory standards. Method suitability and routine sterility testing is performed in an ISO Class 5 cleanroom and is consistent with USP ⟨71⟩ and ISO 11737-2 guidelines. If all proper documentation is received and prior to 12pm, sterility testing is put on test the same day as our lab receives it.
The Bacterial Endotoxins Test (BET) is an in vitro assay for detection and quantification of bacterial endotoxins for injectable pharmaceuticals and medical devices with direct or indirect contact to the cardiovascular system, lymphatic system, or cerebrospinal fluid. LexaMed offers accurate, reliable, and fast bacterial endotoxin testing to help you meet industry standards. Inhibition/Enhancement validations and bacterial endotoxin assays are tested in accordance with USP ⟨85⟩/⟨161⟩ and ISO 11737-3.
A Bioburden test determines the total number of living organisms in or on a medical device, container or component. It is performed on any product that requires control and/or monitoring of bioburden counts. LexaMed offers a rapid 10-day turnaround for routine bioburden determination, combining speed with unmatched accuracy. Bioburden recovery validations and routine determinations are performed per ANSI/AAMI/ISO 11737-1.