// Quality
Production
The quality of our products starts with water. The water purification unit is based on a double osmosis and ion exchange system, complying with all international standards and the highest pharmaceutical requirements. Conductivity is always less than 0.2 ยตS/cm.
The first step is the selection of raw materials. We use only the best products available on the market. Checks are carried out from the selection of raw materials to the final stages of labelling and packaging. Our bottling system is fully automatic and flexible.
Stable liquid reagents
Concentrated bulk manufacturing
OEM manufacturing
Concentrated powders
Customized packaging and labeling on customer request
Gesan offers semi-automatic bottling for small quantities. Each stage of production is monitored by control procedures, with routine laboratory analyses ensuring the quality of the production process. In order to obtain CE marking, all reagents are tested according to international guidelines. The methods are developed on the most common analysers, serving the application support department.
In our warehouse, cold room temperatures are monitored 24 hours a day to ensure that the cold chain is maintained.
// Raw materials
Quality starting with water
Water is the fundamental element in the formulation of IVD reagents, and its purity is a critical factor that directly affects test accuracy. For this reason, our production process begins with the use of reagent-grade water that complies with international standards.
We have a sophisticated treatment system that combines double reverse osmosis with ion exchange deionisation. Through continuous monitoring, we maintain the water conductivity value consistently below 0.2ฮผS/cm. This rigorous control ensures ultra-high purity that eliminates any potential analytical interference, ensuring maximum stability and reliability of our Clinical Chemistry products.
// Raw materials
Total Traceability
The reliability of diagnostics depends on the quality of each individual component. For this reason, our company policy requires the exclusive use of the best raw materials on the market, meticulously selected and certified for in vitro diagnostic use.
Quality control is not a final step, but a continuous process integrated into every stage of the supply chain, from the selection and acceptance of raw materials (incoming QC) to packaging and final labelling.
Production is managed by a fully automated and flexible filling and packaging system. Automation minimises the risk of human error and contamination, ensuring batch reproducibility and dosing accuracy. Every stage of the process, including preparation, bottling and capping, is recorded and traceable, ensuring full compliance with IVDR quality and regulatory requirements.
