What are the effects of using a Glutaraldehyde solution with the ViVitro Labs systems?

Glutaraldehyde solutions are used by medical device manufacturers as a sterilization, a fixative or a storage agent for biological heart valve prosthesis and other devices with biological tissues. Depending on the use and the process, the concentration of such solutions can range from 5% to 0.2%. Occupational hazards related to handling glutaraldehyde solutions have been extensively reported by various agencies, as laboratory personnel can be exposed to glutaraldehyde through inhalation or skin contact.

ViVitro Labs does not recommend using any glutaraldehyde solution during testing as it could damage components of test systems and potentially void warranties. In addition, the handling of glutaraldehyde solutions in large quantities (1L to 2L) would require special handling procedures to protect both laboratory personnel and the environment.

PMMA is used extensively in the design of the test chambers of the ViVitro Labs Pulse Duplicator and the AWT system with DCT. The chambers will lose their transparency after repeated exposure (more than 7 days) to glutaraldehyde disinfectant solutions at 37°C. Polycarbonate resistance to glutaraldehyde solutions is poor and would damage polycarbonate the pressure sensors as well as the luer locks and the fittings used to connect them.

Physiological buffer solutions or DI water should be used when performing accelerated fatigue resistance studies on heart valve prosthesis and other implantable devices. Any other solutions could introduce unrealistic test conditions and further accelerated the wear of test samples.

ViVitro Labs recommends adding a biocide with the test solutions to reduce bioburden and extend the life of the system. Possible biocides include Cosmocil QC (or the generic brand, Biguanide 20). ViVitro uses Cosmocil at a concentration of one drop per litre of fluid. Please use supplier concentration recommendations if you choose to use other solutions. See wetted materials list in the specific user manual for material compatibility.