Cell counter/PCV tubes
The PCV tube enables a quick and reproducible measuring technique of the cell volume. This method is ideal for the monitoring of the tissue growth (cell mass). After a short centrifugation in a micro centrifuge, the cell volume shows as a pellet in the PCV capillary. With the „easy read“ measuring device, developed by TPP, the volume can be read. During a production process many parameters need to be optimized, many samples accumulate at the same time. Here is a quick analysis with the PCV tube and the read out process with „easy read“ the method of the choice.
|Endotoxin||Free of detectable endotoxins (pyrogens) Representative product test with Limulus Amoebocyte Lysate test (LAL) resp. bacterial endotoxins test (BET) according to the guidelines United States Pharmacopeia (USP) general chapter and European Pharmacopoeia (EP) general chapter 2.6.14.|
|Cytotoxicity||Non-cytotoxic, proven by representative test according to ISO 10993-5:1999 and USP chapter 114|
|DNA/RNA||Free of detectable DNA/RNA and ATP|
|DNase/RNase||Free of detectable DNase/Rnase|
|Level of Endotoxins||Detection limit: <0,06 EU/ml|
|SAL-3||Sterility Assurance Level: SAL 10-29|