October 2024

PQ merupakan tahap validasi yang menggunakan ruang sterilisasi Ethylene oxide untuk menunjukkan bahwa peralatan sterilisasi Ethylene oxide beroperasi secara konsisten sesuai dengan kriteria penerimaan yang telah ditentukan dan prosesnya menghasilkan produk yang steril dan memenuhi persyaratan yang ditentukan.

Dalam OQ, kinerja sistem tambahan yang relevan harus ditentukan dan sistem perangkat lunak harus diuji dengan mensimulasikan kondisi kesalahan.

a.Equipment to be used in the sterilization process, including any ancillary items, shall comply with its design specifications.The corresponding documents include functional design specifications, user requirements specifications, design drawings, etc. (Equipment schematic diagram, energy supply diagram, electrical schematic diagram, system schematic diagram, etc.)

Alat sterilisasi etilen oksida beroperasi pada suhu rendah, menjadikannya ideal untuk mensterilkan perangkat dan instrumen medis yang sensitif terhadap panas. Karakteristik ini memungkinkan terpeliharanya integritas dan fungsionalitas perangkat medis kompleks yang mungkin rusak karena panas.

Protection mechanism and explanation OF ETO Sterilizer System 2. By default, the system will perform the leak detection test before

1.Purpose for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been

ethylene oxide in sterilization Introduction ETO is a colorless gas that is flammable and explosive. The four essential parameters (operational

The Detail EtO Sterilization Cycle A typical EtO sterilization cycle comprises three main stages: Preconditioning This stage prepares the chamber

Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility.

Ethylene Oxide (EtO or EO) sterilization is a colorless gas broadly utilized in different businesses, including the generation of materials, individual care items, and the eto sterilization of therapeutic gadgets, makeup, and flavors. EtO is an essential strategy for sterilizing restorative gadgets, playing a crucial part in avoiding contamination in patients experiencing surgical methods and other restorative treatments.