NovaSeptum samplers upgraded
to reduce the level of endotoxins to a level that falls well within
strict new guidelines set down by the European Pharmacopoeia.
New production techniques at the company have resulted in a reduction in the guaranteed endotoxin level from less than 20EU/device to less than 2.15 EU/device on all NovaSeptum products.
The European Pharmacopoeia, along with its counterpart in the US, has tightened up the acceptable limits for endotoxin contamination - used as a marker for bacterial contamination in products designed to be sterile - in both packaging and materials used in aseptic processing of drug products.
The NovaSeptum range takes the form of an enclosed disposable system of connectors, tubing and sample bags that allows drug manufacturers to extract samples from the production process without risk of contamination, removing the need to clean and steam-in-place between tests.
The company claims that the system eliminates false positives associated with aseptic liquid sampling, and reduces the time each procedure takes. NovaSeptum can also be used for aseptic transfer of liquids into the process system.
Other product enhancements to the range include the introduction of an autoclavable version for applications where mobile production vessels are autoclaved whilst fully assembled, and a new 2mm sample needle designed for cell culture applications and suspensions.
