In one of the previous entries, we have presented the services of a microbiological and chemical laboratory that LABOR can provide to external contractors. However, we would like to introduce you to this topic a bit and explain what the individual points from our offer consist of.
We start with the Microbiological Laboratory!

 

Tests of microbiological purity of water, raw materials and packaging materials, medicinal products and dietary supplements.

In the production process of both drugs and dietary supplements, it is very important to maintain the appropriate microbiological quality – not only of the finished product, but also of water, raw materials and packaging materials (e.g. foil and containers) used for production. This has a direct impact on the quality of the finished drug or dietary supplement.

By checking the microbiological purity of the above-mentioned raw materials, we check whether the amount of bacteria and fungi in the given material used in the production of the drug / dietary supplement does not exceed the standards set out in the Polish Pharmacopoeia. This marking is a quantitative marking and consists of two parts:

  • TAMC test – Total Aerobic Microbial Count, total number of aerobic microorganisms,
  • TYMC study – Total Yeast / Molds Count, total number of yeasts and molds.

The result is given as either CFU / g or CFU / ml, where CFU stands for Colony Forming Unit.

In addition to the TAMC and TYMC tests, we check whether the materials for production contain microorganisms that should not be there at all – in this case it is a qualitative indication. The presence of microorganisms that may have a negative effect on the health of the consumer is analysed here, e.g. Escherichia coli (colitis), Salmonella, Staphylococcus aureus (golden staphylococcus) – depending on the requirements of the relevant specification.

Only when we demonstrate that the microbiological quality of water, raw materials and packaging materials in direct contact with the product meets certain standards, we can safely use them for the production of a drug / dietary supplement. After the end of the production process, employees of the Quality Control Department collect the final product for analysis and the microbiological quality of the finished product is verified (quantitative and qualitative analysis) in accordance with its specification. The product tested in this way, meeting the required standards, is safe for the patient and can be taken without fear of poisoning by microorganisms and their metabolites.

In our Microbiological Laboratory we can check the purity of the raw material or the finished product sent to us. If you need to perform such an analysis, please contact us. We invite!

AUTHOR: mgr inż. Katarzyna Trębicka