PRODUCTION AND CONTROL OF MESOEXPERT MESOPREPARATIONS
MesoExpert mesopreparations are produced in their own clean room, a class 7000 facility. In the laboratory, the staff works in an aseptic environment under laminar units. Meso preparations from Rofil are sterilized by the nanofiltration process. Most other manufacturers sterilize by autoclaving (high pressure, hot steam (121 ° C), which can damage the active ingredients in the product. This will not happen if the final product is sterilized by the filtration process: the percentage of active ingredients in the final product will not change.
Laboratory cleaning metaproperty
The filtering process of preparations:
The process of filtering the active mesococtail solution begins with pressing a special 0.22 microns sterile membrane filter to separate microorganisms and suspended particles from the final product. All active ingredients pass through the membrane and are cleared of fungi, bacteria, and impurities. Then the solution goes through the second stage of sterilization under the influence of low temperatures.
The components remain in a stable state, and the concentration of active ingredients does not change during the entire production stage.
Filtered products are immediately poured into sterile vials and closed. Filtration, filling and capping processes are fully automated and continuous, which guarantees the preservation of the sterility of the final products. All these procedures occur under a massive block of laminar flow and in septic States.
Filtering preparations MesoExpert
For our products, we use only Schott pharmaceutical-grade vials, from which all steps in production are tracked according to the DIN ISO 9001:2000 GMP quality management system. Injection plugs, used to close vials after filling, are manufactured in the West. Rubber plugs made of bromobutyl. The plugs are washed by final rinsing in injection and packaged in a class 100 clean room in sterilizableBAG ™. The final closure of the vials uses Flip-Off® CCS aluminum seals that are easy to open and certified for use in septic operations. These are steps to ensure safe transportation and storage of products. This also prevents contamination by fungi, bacteria, etc., during transport and storage.
After production, all filled vials are quarantined for quality control. Microbiology includes testing for bacteria, fungi, and yeast, stability testing, pH testing, and 100% visual testing to make sure there are no solid particles and no leakage. This procedure ensures that products always meet their specifications for appearance, sterility, and quality. The release report (certificate of analysis) is issued for each batch of products. Only then is the product ready for sale.