Because the [sup.41]Ca solution was given to human subjects, considerable effort was made to characterize it in terms of elemental composition, radioactivity, sterility, and pyrogenicity
. The administered solution was free from heavy metal contaminants, and only 2 elements, sodium and calcium, were found at >1 part per million (Fig.
In the second stage, they undertook to develop and validate newer and more sensitive human-specific in vitro and alternative models of neurotoxicity, developmental neurotoxicity, cytotoxicity, pyrogenicity
, phototoxicity, hepatotoxicity, immune-toxicity, genotoxicity, oral toxicity, and so forth.
The extrusion process requires no cooling/processing with water, eliminating pyrogenicity
This manufacturer of silicone-based materials for healthcare, aerospace, electronics and photonics has extended its biocompatibility support to include sensitization, genotoxicity and pyrogenicity
testing for its line of pigmented silicone masterbatches.
This includes tests for cytotoxicity (ISO MEM elution and colony forming assay), sensitization (Kligman), intracutaneous irritation, systemic toxicity, implantation, pyrogenicity
(LAL and in vivo) and genotoxicity (reverse mutation, chromosomal aberration and mouse micronucleus assay).
One large family of toxins in this category are the pyrogenic toxin superantigens (PTSAgs), whose hallmark biological activities include potent stimulation of the immune cell system, pyrogenicity
, and enhancement of endotoxin shock (49-51).
Dow Corning Corp.'s Silastic medical-grade silicone elastomers are reported to meet rigorous biosafety tests for medical applications, including pyrogenicity
and skin sensitization tests, tissue cell cultures, 90-day implant tests, and lot testing for 28 trace metals.
The three tests commonly used to measure pyrogenicity
are the in vivo rabbit pyrogen test (RPT), in vivo Limulus amoebocyte lysate (LAL) assay, and the in vitro monocyte activation test (MAT).
These include cytotoxicity, hemolysis, sensitization, and pyrogenicity
. This also includes USP Class VI testing of plastics, for systemic toxicity, intracutaneous toxicity, and implant.
A few in vitro tests are starting to make it into this testing portfolio (biocompatibility (145), skin irritation, skin sensitization, pyrogenicity
testing), but there is certainly room for improvement.
Burron OEM's staff of professional microbiologists and chemists conduct extensive testing for sterility, toxicity, pyrogenicity
and heavy metals.