The production of sterile injectable line is significantly different from the preparation of Tablets Manufacturing Line. A notable difference is that the injectable production line is contained in a pressurized environment (10-15 Pa). The production of sterile injectable pharmaceuticals also requires pure, sanitized water, not for the manufacturing itself, but for the sterilization of the vials and ampoules which will contain the finished product.

As with the oral pharmaceuticals, the production process begins with the API and IPI components being checked by governmental FDA which tests the raw materials according to pharmacopeias standards (European or USPS) and using EUPH or USPS standards for assay and for impurities. They issue a quality certificate for that raw quantity that was imported allowing us to process into final product. Product is tested during production and in form of final product by our internal GPL laboratory to be in accordance with GMP standards.

Our facility utilized an Automatic Ultrasonic Washing Machine to wash and clean the vials and ampoules, and then a sterilization tunnel prior for their delivery to the filling machines. The filling process is monitored and verified by our quality control team with the coalescence of the ampoules; also the sealing process of the vials is verified. This verification is necessary to ensure no leakage of product during the distribution of the pharmaceuticals and to prevent post-production contamination.

Once the batch get our internal laboratory certificate for quality, it will be tested again as final product by governmental laboratory and based on that certificate we get approval to put on market that batch. So we are carefully inspected as required by national authorities from stage of importing raw materials to final product, this ensure that never can be put on market a product that is under quality.