Validation of the bacterial count for a pharmaceutical product: and development computer application

The methods described in the Pharmacopoeias are regarded as validated, which means that they are suitable both for bacterial enumeration and for the detection of specified microorganisms. Our study focused, on the one hand, on carrying out a specific validation of certain pharmaceutical products and, on the other hand, on developing software designed primarily for data logging and calculation, to meet specific requirements. The relational database chosen was Oracle, which runs on UNIX, Windows 2000 and Windows XP; the development tool used was Developer 2000. The various criteria examined were, respectively: specificity, reproducibility, repeatability and robustness. In conclusion, the statistical analysis demonstrated the validity of the values obtained during the bacterial count.