Sterile pharmaceuticals and sterile medical products need to be tested to make sure that they are free of endotoxin in order to rule out bacterial contamination. These include highly invasive pharmaceuticals, such as infusion solutions or excipients such as water for injection (WFI). In addition, non-sterile bulk goods or in-process controls can also be tested for endotoxins. In addition to the proven LAL test (limulus amoebocyte lysate test), WESSLING now provides producers of pharmaceuticals with the rFC test (recombinant factor C test). This rFC test is a proven alternative method which will also be included in the regulations of the European Pharmacopoeia from 1 January 2021 (according to Ph. Eur. 2.6.32).
2. High quality
3. High performance compared to the LAL test: