Method ico medical Necessities:
METHOD OF THE PRODUCTION:
A- The areas of production are clean and in accordance with International Standards per ISO 14644-1 ISO 8As, which is controlled by the number of particles in the air as well as temperature, humidity , pressure difference and it is done in order to control the environmental conditions of the production areas, leading to prevent and reduce bacterial growth, or the entry of minute objects and control the number of particles to ensure the safety of the product from any microbial contamination or molecular - Sterilize the product is the latest methods of sterilization and the latest devices used for this purpose where the ethylene oxide gas sterilization under the optimal conditions for the sterilization process and set forth in International Standards.
· .ISO 11135-1:2007
· .AAMI TIR-15:1997
· .AAMI TIR-16:2000
1- Physics: In this section the product is tested in terms of different physical properties measured by tensile age and measuring the leak tests, etc..... physical crisis to ensure the safety of the product in terms of physical properties.
2- Laboratory Chemistry: We test the raw materials in terms of chemical composition and safety of raw materials used in the manufacturing process in terms of medical chemical properties and their impact on the health of patients and their impact and interaction with the quality of drug user.
3- Microbiology Lab: It is equipped with all devices that are used in microbiological analysis for this area.