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. NovAseptic claims the system has become the preferred method for pharmaceutical companies taking routine controlled samples of high purity liquids.
A trend towards an increase in product potency and increase in the number of high-value biologic drugs coming through development and onto the market are increasing the need for low volume analytical tests, as low product wastage translate to value savings), according to NovaSeptic.
But until now, the only method of retrieving small liquid volumes accurately has been by incorporating a needle and syringe introduced directly into the process media via a septum membrane, which carries risks in terms of false positives and operator safety and is also very difficult to validate.With the introduction of the NovaSeptum AV, NovAseptic can now provide the accuracy of the syringe method, coupled with the other inherent aseptic techniques of the NovAseptum system, which eliminates false positives associated with aseptic liquid sampling, and reduces the time each procedure takes.
"Throughout the entire process of sampling with the NovaSeptum AV, a totally closed sample is maintained, allowing for the sample to remain totally representative until the moment it is discharged at point of analysis," said the company.