33 "Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods".
The report focuses on the use of these methods in pharmaceutical, biotechnological and medical device industries to assure product quality.
They also suffer from some of the same problems: if an organism cannot grow it cannot be detected.
Only non-growth based methods are able to provide results within several hours and are able to detect all viable organisms.
The time needed to obtain a sufficient visual detectable concentration ranges somewhere between 2 and 14 days (sterility test).
The inability to obtain timely results for microbiological quality control may lead to less control over the production environment and increased production costs (inventory costs, batch rejection, etc.).
We support you in overcoming hurdles such as large equipment investments, having a multi-disciplinary team available (technical, validation, quality and regulatory experts) and time constraints.
The implementation of Rapid Microbiological Methods for Batch Release and/or In-Process-Control can result in substantial economical and scientific benefits even though most of the alternative methods require a substantial initial investment.
Living cells with an intact cell membrane are capable of retaining and accumulating this fluorochrome.
A laser scanner detects and locates the fluorescent signals originating from the fluorochrome.
Micro-organisms that will not grow in the selected growth conditions (growth media, temperature) or micro-organisms that have lost the ability to reproduction will not be detected.
Examples of pathogens that occur in a hospital environment and cannot be detected by traditional methods are .