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NovAseptic Sampling Systems Eliminate the Risk of False Positives

Sampling to verify the acceptability of an aseptic pharmaceutical drug product has always been a procedure of ultimate importance relating to any validatable production process.

NovAseptic has developed a totally unique, pre-sterilized, disposable, and totally enclosed sampling system that will assist in the elimination of false positives.

By incorporating the NovaSeptum you can eliminate the requirement to clean and steam in place between samples.  Furthermore, you can be assured that your sample will not be compromised from point of sample to point of analysis.

The NovaSeptum has been validated for use by many of the world’s leading Pharmaceutical and Biotechnology Companies. 

Recent product enhancements have further increased the demand for the NovaSeptum, these being the introduction of an autoclavable range for applications where mobile production vessels are autoclaved whilst fully assembled, a new 2mm sample needle designed for cell culture applications and suspensions, and the introduction of a three piece sample retrieval assembly which provides complete flexibility and security for the person responsible for sample analysis.  Additionally, new production techniques has resulted in a reduction in the guaranteed endotoxin level from <20EU/device to <2.15 EU/device on all NovaSeptum products.

For those currently using the NovaSeptum, the following inherent advantages are being experienced:

  • The totally enclosed system ensures that false positives are eliminated
  • The pre-irradiated unit negates the need to sterilize between each sample
  • Sampling time is dramatically reduced
  • A representative sample is provided every time
  • Operator safety is guaranteed
  • Flexible hardware configurations ensure that samples can be taken from anywhere within the process system
  • Comprehensive documentation packages reduce validation time
  • The same system can also be implemented for aseptic transfer of liquids into the process system 

For further information email Neil Robinson, Managing Director, NovAseptic UK Ltd on neil.robinson@novaseptic.co.uk  or visit the web site www.novaseptic.com

 

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