Currently, certification of the absence of contamination in pharmaceutical products and parenteral equipment is extremely important to guarantee the quality and public health standards, particularly for pharmacology and hospital area,...
moreCurrently, certification of the absence of contamination in pharmaceutical products and parenteral equipment is extremely important to guarantee the
quality and public health standards, particularly for pharmacology and
hospital area, since contaminated devices and medications may not
not only cause fever but also how aggravate the clinical condition of the patient,
allowing the emergence of conditions such as septicemia and even death.
To this end, the investigation of the contamination of such materials is carried out through the
pyrogenicity test in rabbits (recommended by the US pharmacopeia)
as a standard to serve as identification. However, in recent years, attempts
use of alternative methods, encouraged by the premise of the 3 R's has
intensified the search for in vitro methods, such as the methods that use the Lysate of
Limulus amoebocytes (LAL) and others. The present study aims to
address, through a literature review, the effectiveness of alternative methods,
especially those using LAL compared to the Standard method of
pyrogenicity in rabbits (RPT) already advocated. Platforms used were
searches Google Scholar, SciElo and ProQuest, obtaining 39 results addressing
pyrogen identification methodologies. It was concluded that the in vivo test has
greater range of applications, although it has the animal handling factor as a limiting factor;
the LAL is essentially specific but effective and the MAT is the main
candidate of the alternative methods, having the greatest range of applications than the
LAL, but it still needs to be validated in comparison to the in vitro method with
LAL and a greater variety of reagent monocytes need to be developed to
level its equivalence to the in vivo method. It was found that the RPT test
although controversial for animal handling and interspecies extrapolation, it still
is essential for the certification of quality standards, although the tests
alternatives most used with LAL and MAT are quite promising and many
times more economical and viable or more replicable.
