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New URS generator for aseptic mixing of liquids

A Millipore product story
Edited by the Processingtalk editorial team Aug 15, 2005

NovAseptic UK announce the launch of a unique User Requirement Specification generation tool for use with in the pharmaceutical and biotechnology industries, available on request

NovAseptic UK announce the launch of a unique User Requirement Specification generation tool for use with in the pharmaceutical and biotechnology industries.

This unique support tool will not only assist in specifying the correct mixing system for the process but will also provide the end user with the optimum mixing vessel dimensions and aspect ratios.

When specifying an aseptic mixing system, there are many parameters that need to be considered.

Mixing systems are used for many varied applications throughout the pharmaceutical industry including suspending, homogenising, emulsifying, heat treatment and suspending to name but a few.

Each individual application has its own unique process and validation issues that need to be addressed.

All too often, the end user/drug manufacturer specifies the equipment based on historical data, understandably with the sole intent of reducing validation time.

In other words they specify a process and equipment that have been used previously to minimise the re-validation work that would ordinarily be required if they were designing a completely new process.

This methodology does have its merits, however, it does mean that advances in new technologies that could provide longer term benefits are not considered.

In order to gather information on the critical process parameters and to allow their Biotechnology partners to consider innovation within their processes, NovAseptic UK has developed a User Requirement Generator tool.

The advantage being that the client does not need to pre-design their production vessel, prior to specifying the optimum mixing performance.

In other words NovAseptic will specify the optimum conditions for mixing based on your required end result.

This interactive questionnaire prompts the client to answer a few simple process specific questions.

From the information gathered, NovAseptic will be able to specify the correct mixing process for the application and will be able to advise on optimum vessel height to diameter ratios to ensure that the optimum mixing performance is achieved throughout the process.

In many cases optimum mixing performance can be achieved across many different mixing volumes within the same vessel, providing increased flexibility of batch processing.

The User Requirement Generation Tool has been developed for low and high shear applications and is available on request from NovAseptic UK.

To compliment this unique new tool, NovAseptic has also designed a 1/2 day information gathering training course titled "How to Specify a Mixing System" which can be performed by one of their Technical Support staff at the customers premises.

To further support its clients in proving their process will provide the specified results, NovAseptic recently opened their process testing centre which is designed for the pre-validation of mixing processes.

This approach minimises the impact on their customers design and validation lifecycle when considering new technologies.

The NovAseptic range of mixing solutions include.

* Magnetically driven bottom mounted mixers for high and low shear applications.

* Magnetically driven bottom mounted mixers for upstream applications.

* New in-line high shear mixer for in process use.

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