The production process of water injection mainly includes ampoule washing, preparation of raw and excipients, solution preparation, liquid potting, moist heat sterilization, printing, packaging and other steps.
Water injection refers to water-soluble injection. It is the most widely used and representative injection among the four types of injections (i.e. solution injections, sterilized powder for injection, suspension and emulsion). The production of water injection is a production process in which water for injection is used as a solvent to dissolve the drug and seal it in an ampoule, so it is also called a small injection.
Water Injection Process
After the raw and auxiliary materials of water injection are weighed and batched, they are added to the concentrated tank and fully stirred with water for injection. The auxiliary activated carbon will absorb and remove impurities and pigments. , the medicinal liquid is transported by the sanitary pump, filtered by the titanium rod filter and enters the dilution tank. Water for injection is then added to the dilution tank to dilute the medicinal liquid to the concentration required for the process. It is transported by the sanitary pump and filtered twice by the titanium rod filter. Send filling jobs.
The ampoules undergo ultrasonic cleaning, multiple needles for alternating water and vapor cleaning, thermal laminar flow sterilization, and laminar flow purification. After being filled with dilute medicinal solution through multiple needles, they are drawn and sealed, and then passed through a water bath sterilization cabinet. After passing the sterilization and light inspection, it will be outsourced and put into storage.
Production area
The production area and equipment should be reasonably laid out according to the process flow. The layout of the water injection workshop should mainly consider reasonable zoning to ensure a smooth process flow. Water injection includes raw material storage, weighing and dispensing area, ampoule storage, washing and drying area, liquid dispensing area, filling area, sterilization area, light inspection area, outsourcing area, washing area, etc.
The dilute preparation room should be adjacent to the concentrated preparation room and canning room to facilitate the transportation of liquid medicine and the disassembly and cleaning of pipelines. The transportation pipelines should be installed under the suspended ceiling. The production area must have an area and space suitable for the production scale to arrange production equipment and materials to ensure reasonable connection of production operations.