Product category:
Mixers, Blenders, Grinders and Mills
News Release from: Millipore | Subject: Mixing systems
Edited by the Processingtalk Editorial
Team on 04 February 2004
Selecting and validating the mixing
processes
NovAseptic have introduced innovative and unique pre-validation procedures to ensure that their customers will get the mixing systems and processes that will exceed all their requirements
Implementing a new aseptic mixing process has traditionally been a trial and error procedure, often resulting in long drawn out pre-validation and on-site validation periods Flexibility in terms of mixing volumes and product formulations has been difficult to incorporate into a system due to lack of confidence in the mixer performance over a variable range of mixing capacities and viscosities
This article was originally published on Processingtalk on 24 May 2004 at 8.00am (UK)
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Now NovAseptic have introduced two innovative and unique pre-validation procedures to ensure that their customers not only get the mixing systems and processes that will exceed all their requirements, but also that they will dramatically reduce the amount of time associated with writing User Requirement Specifications and Validation Plans as well as minimize the time for on site validation after delivery of the assembled mixing system.
In the spring of this year NovAseptic will unveil their brand new research laboratory and pre-validation suite, which is dedicated to the sole uses of product development, customer pre-validation and factory acceptance testing.
The driving force behind the pre-validation suite has been their customers who see a need to incorporate innovation and "Right First Time" process methodology into their facilities.
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On the majority of occasions their pharmaceutical manufacturing and biotechnology customers have specified their mixing processes based on historical data and experience because "it worked in the past".
Although this philosophy is commendable and very common, it has meant that they have been unable to take advantage of new and innovative technologies due to the fear of change and of protracted time scales associated with compiling new specifications and validating new processes.
Installed within the new NovAseptic pre-validation suite will be a range of production vessels with the capability to install any of the NovAseptic range of aseptic bottom mounted magnetic mixers.
The aim was to incorporate the ability to simulate any mixing process across the range from 10 to 30,000 litres, which has been achieved.
This equipment and facility will be available for use by all our customers for the purpose of mixer selecting, pre-validating the entire mixing performance across all relevant mixing ranges, and for the factory acceptance testing of the assembled mixer including the simulation of the CIP/SIP procedure using clean steam and water.
It has been proven on many occasions that this type of support function will not only eliminate any risks associated with the selection of the hardware and the process itself, but it will dramatically reduce the amount of validation required at the user's site.
For those customers who take advantage of the NovAseptic pre-validation suite, they will be furnished with all the supporting information to enable them to write their User Requirement Specifications and Validation Plan based upon proven performance data.
This package will include the following options.
Mixer Documentation.
Copy of completed detailed mixer/process selection questionnaire and sizing programme.
Mixer component drawings and data sheets.
Operator and Maintenance Manual.
Copies of material certificates.
Installation instructions.
Welding guidelines.
Test Report.
Vessel drawings.
Configuration report detailing type of mixer installed and mixing head used in the vessel.
Spreadsheet detailing mixing levels, mixer speeds and mixer test results.
CIP report if applicable.
Photographs and/or a video of the tests performed across the process range.
Prior to visiting their pre-validation suite NovAseptic will carry out a detailed selection and evaluation procedure, usually at the customers premises or in the form of a seminar at one of their seminar venues.
This procedure is essential in identifying all the relevant variables that could influence the specification of the mixer, vessel or process performance.
A NovAseptic technical representative will start by giving an overview of the mixing procedures and technologies that are available today followed by an analysis of any historical data that will assist in determining the target specification.
This will be followed with a detailed review of all the variable aspects that would not only influence the specification of the mixer, but that could also have an effect on the smooth executions of the project in general.
Again, this is where NovAseptic stands out from all other mixer suppliers.
The information that will be drawn out during this session will assist the customer in compiling their user requirement specification and will identify the areas that need clarification or investigation during the aforementioned pre-validation procedure.
The variable aspects that are covered and documented include the following.
Understanding the applicable standards (including ATEX review).
Determining the type of mixing process.
Listing the product being mixed and their characteristics.
Review of environmental considerations.
Sizing the mixer to suit all procedures to be performed in the subject vessel.
Determining the mixing speed across all ranges.
Mixing duration.
Review of other mixing parameters such as vortex generation if required.
Vessel design consideration.
Materials of construction.
Documentation requirements.
CIP/SIP philosophy and procedure.
Installation procedure and utility requirements.
Validation policy.
Service support requirements.
Budgets.
Project management and time scale.
Staff Training Needs.
Operating the mixer.
Novaseptic are convinced that the approach of involving their customers as early as possible within the selection process, and by introducing these two new pre-validation procedures is assisting their customers in nearing their goal of "Right First Time" process performance.
Their aim is to ensure that mixing techniques are taken to a new level of reliability and flexibility.
NovAseptic believes that "Process Flexibility" and "Reduced Validation", two phrases that are very rarely linked within the Pharmaceutical sector are very achievable with their new approach to the industry. Request a free brochure from Millipore ...
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