RMM in pharmaceutical companies

Rapid and sensitive detection and quantification of microbial contamination is of utmost importance for Pharmaceutical companies and biotechnology companies. Process monitoring, including compound testing, product testing, environmental monitoring and WFI analyses, is key for highest quality of pharmaceutical and biotech end products.

To meet the high industry standards with low limitations of bioburden, large volumes need to be evaluated for microbial contamination to enable reliable analysis. Each microbial method used should be highly sensitive, applicable for larger volume testing, rapid and reliable.

These requirements often imply complex methods and are time-criticals, as time has a direct effect on production efficiency and costs. Results should be available the same day.

The Sieve-ID method with MuScan analysis meets these requirements.

Validation according to USP[1223] and Ph.Eur 5.1.6

The Sieve-ID method with MuScan analysis is validated according to USP[1223] and Ph.Eur 5.1.6 at Innosieve Diagnostics, but is also being validated at major pharmaceutical companies. The results show to be equivalent to, or better than the compendial methodology for bioburden testing. All pharmacopoeia recommended reference strains have been evaluated, giving higher precision and more reliable quantification. The overall limit of reliable detection was found to be 2-5 FFU per volume with accurate quantification up to high contamination levels.

Example of linearity of both the compendial method and the Sieve-ID method for Escherichia coli. No significant difference is observed between both methods (Based on non-linear Poisson distribution in statistical analysis).

A comparison of a direct rapid method like the MuScan method with a reference growth-based method requires additional statistical needs and experimental approaches. As a growth-based method measures the counts in CFU (Colony Forming Units), the number of counts is highly dependent on growth parameters like pH, nutrients, temerature etc. Next to that, a microbe might be dormant or as so-called VBNC (Viable but Non Culturable) and will thus not form a colony. This is in high contrast with a direct microbial method, as these measure in FFU (Fluorescense Forming Units). All microbes that are viable are detected, including VBNCs. As of this contrast, during validation studies good care should be taken in experimental design to avoid misinterpretation of either methods.

For detailed information about the method compliancy, please contact us.

CFR21 part 11 compliance of software

  • The license-based software package allows a fully digital data processing, storage and accessibility. It requires the so-called double-eye confirmation, strong password management and logging to prevent misusage or data manipulation. Dependent on the company rules the signing process can be linear or cyclic. Herewith maximum flexibility is offered for the CFR21 part11 compliant MuScan software.

    The software is user-friendly and offers detailed analysis per sample and image. Reviewing is made easy; checking and signing is allowed in an easy overview of tests to be signed with clear notifications where attention is advised.

    The software is server-based. All data is accessible by the user independent of the PC, laptop, tablet or phone. The software is responsive, presenting the results in a well readable format, independent of the device being used. All data is stored on the company server and is only accessible as read-only format.

Highest standards. Let's go for it!