Today we invite you to another entry on laboratory services offered by the LABOR Company.
We have already written about the microbiological examination of medicinal products and dietary supplements. However, it is not the only test of this type performed in a plant producing the above-mentioned preparations. We must be sure that not only the raw materials used for production and later our products themselves do not exceed the standards when it comes to the amount and type of microorganisms present there – the working space itself is also subject to microbiological limits, i.e. rooms and devices in which the production process takes place. .
What does this type of examination look like? First of all, the microbiological purity of the air is checked. This analysis consists in taking a specific volume of air at selected points – a special device is used for this, into which a plate with a medium for growing microorganisms is inserted. The air flowing through the system settles the microorganisms present on the plate surface. The media is then sealed and incubated under appropriate temperature conditions to check the amount of microorganisms that have grown on the plate and that the amount is within the specified standards.
The analysis of microbiological purity of devices and such elements of production rooms as doors, walls, floors and ceilings looks slightly different. For this purpose, small, convex plates with the medium are used, which are simply applied at fixed points, so that any microorganisms present in these places are collected on the surface of the substrate. Then, as in the case of air testing, the plates are incubated under appropriate temperature conditions, after which the number of microbial colonies grown is counted and compared to the specified standards. If they are exceeded, these places are ordered to be cleaned again and then tested again in accordance with the previously described methodology.
The microbiological safety of end products is ensured not only by the appropriate quality of raw materials used in production, but also by the proper cleanliness of the places and devices where the production takes place. If you would like to commission us to monitor the microbiological cleanliness of the workspace in your company, please contact us at: laboratorium@labor.com.pl, b.wieclaw@labor.com.pl or r.kowalczyk@labor.com.pl.
Together, let’s take care of high standards in the production of drugs and dietary supplements!
AUTHOR: mgr inż. Katarzyna Trębicka