Information on Contract Sterilization Services [Steritech Co., Ltd.]
We can also handle sterilization validation services, various bacterial tests, and residual gas analysis, including EOG sterilization and gas sterilization.
The history of EO gas sterilization in Japan is something we take pride in, as it can be said to be synonymous with our own history. In other words, since our establishment in 1963 for the purpose of selling the first gas (Capox-Epon) and gas sterilization equipment in our country, we have rapidly spread the use of sterilization in the fields of medical disposable products, pharmaceuticals, and cosmetics, leading to the present day. We utilize our accumulated know-how to provide contract sterilization services with the installation of gas sterilization equipment. Additionally, at our headquarters in Kobe, we also conduct sterilization validation services and various bacterial tests, as well as gas residue analysis. Please contact our staff for inquiries.
basic information
Medical Device Sterilization Validation Procedure (Half-Cycle Method) 1. Creation of Validation Procedure Document 2. Creation of Validation Implementation Plan Document 3. Confirmation of Equipment Qualification 4. Confirmation of Operational Performance Qualification 5. Creation of Validation Results Report 6. Creation of Contract for Commissioning Manufacturing Equipment ● EOG Gas Sterilizer ● Preconditioning Device ● Air Relator ● Exhaust Gas Treatment Equipment ● Measurement Instruments for Validation Medical Device Manufacturing License Numbers 11BZ200080 (Head Office) 28BZ006013 (Western Japan Branch)
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