Validating rapid micro methods

25-Jun-2017 07:03 by 10 Comments

Validating rapid micro methods

From many available systems and methods on the market, an appropriate choice for a Rapid Sterility Test based on ATP Bioluminescence of micro-colonies was made.Before starting the validation work, several pre-studies had to be conducted to determine a suitable range of stressed challenge microorganisms, to evaluate suitable nutrient media and to define the “rapid” incubation time.

After the decision had been made at Novartis that a rapid microbiological method for the replacement of the traditional pharmacopoeial sterility test should be validated, the appropriate method for replacement had to be chosen.In Pharma, a reduction from 14 days to 7 days until release could be achieved.These 7 days consist of the 5 days incubation time of the Rapid Sterility Test and additional days to wait for the results of environmental monitoring, bioburden testing and water analysis (WFI, water for injection).Sterility testing and mycoplasma testing are often cited as the most serious offenders, with a minimum 14- or 28-day release time respectively.Significant costs are associated with holding the product during this time.Important end of the story is the road map to regulatory acceptance of this Rapid Sterility Test, now approved by FDA CDER, FDA CBER, MHRA and by the European Medicines Agency for a number of Novartis sterile products.

Advantages of a Rapid Sterility Test A sterility test is sometimes performed as in process sterility test or it is performed on the finished drug product.This chapter provides guidance on the validation of RMMs.Introduction There are many reasons why the traditional sterility test, with its lengthy 14 days incubation time, should be replaced with a Rapid Sterility Test.Depending upon the method they may also significantly improve the accuracy of the method, the limit of detection, or other key attributes associated with the method.One of the hindrances associated with these methods has been defining what is necessary to validate these methods.Microbiological testing is foundational to the operation of pharmaceutical facilities.

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