Pharmaceutical production equipment validation

As a professional third-party verification company, Yikang Testing has strong verification capabilities and can undertake the majority of domestic chemical and biopharmaceutical manufacturers'The verification work of production and R&D equipment has provided equipment confirmation services to numerous domestic production equipment suppliers, manufacturers, as well as R&D institutions and pharmaceutical factories for biological and sterile preparations, covering brands such as Bosch////////////////B+STheTHERMO////////////////Shandong Xinhua////////////////Tofflon////////////////Chu Sky////////////////Qianshan Medicine Machine////////////////Canaan////////////////Nano////////////////Shuanghe////////////////Fate////////////////Ima and dozens of other brands, the specific verification scope is as follows:

1.Aseptic preparations: fully automatic liquid preparation system, bottle washing machine, filling machine, aseptic packaging machine, sterilization tunnel, capping machine, freeze-drying machine, sterilization cabinet, electronic scale, rubber stopper cleaning machine, aluminum cap cleaning machine, fully automatic lamp inspection machine, weighing hood, liquid preparation tankCIPSystemSIPSystemISOLATORAseptic transfer vehicles, etc.

2.Solid preparations: 3D mixer, wet granulation machine, boiling granulation machine, tablet press, capsule filling machine, aluminum-plastic packaging machine, aluminum aluminum packaging machine, crusher, screening machine, bottling machine, etc.

3.Biological agents: fermentation tanks, bioreactors, etc.

4.Other dosage forms: traditional Chinese medicine extraction equipment, soft capsule production equipment, etc.

5.Packaging equipment: labeling machine, coding machine, fully automatic boxing machine, supervision code system, etc.

6. Validation of clean air conditioning system, validation of plant common equipment (air conditioning system, water system, compressed air system), validation of laboratory equipment (refrigeration box, incubator, sterilization pot)/Cabinets, transfer windows, and ultra clean workbenches.

Service content: For the above instruments, Yikang Testing can provideComputerized System Validation（CSV）Critical assessment of components（CCA）Risk assessment（RA）TheDQ////////////////IQ////////////////OQ////////////////PQAnd related testing services.