A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters. It is typically a device or test package containing biological indicators (e.g., Bacillus atrophaeus spores with known spore count). The resistance of the PCD to the sterilization process should be greater than or equal to the resistance of the natural microbial load in the most difficult-to-sterilize area of the product. The quantity of PCDs should meet the requirements outlined in Table C.3 of Appendix C in GB18279.1-2015. PCDs are classified into Internal PCDs (IPCD) and External PCDs (EPCD).

Industry Eto Sterilizer Installation Verification The installation of Industry Eto Sterilizer and all associated services should comply with the requirements

The humidification water used in the ETO Sterilization Equipment should be free from contaminants, should not weaken the ETO sterilization process, and should not damage the sterilizer, sterilized products, or the load. Humidification should be done by injecting steam, not by directly injecting atomized water.

Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd., commonly referred to as HZBOCON, stands out as a dedicated Ethylene Oxide (EO/ETO) sterilizer manufacturer. Established in 2006, HZBOCON has committed itself to the design, development, and manufacturing of EO sterilization equipment, catering to a wide array of industries that require effective sterilization solutions for thermosensitive products.

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