Process Water For ETO Sterilization Equipment
Air pelembapan yang digunakan dalam Peralatan Sterilisasi ETO harus bebas dari kontaminan, tidak melemahkan proses sterilisasi ETO, dan tidak merusak alat sterilisasi, produk yang disterilkan, atau muatannya. Humidifikasi sebaiknya dilakukan dengan menyuntikkan uap, bukan dengan langsung menyuntikkan air yang diatomisasi.
Note: It is recommended to use purified water that meets the requirements of the Chinese Pharmacopoeia for humidification. If purified water is not used, the steam supply or steam condensate should be validated to ensure that the humidification steam meets the requirements of this section. The steam quality testing methods are outlined in YY/T 1612 and the Chinese Pharmacopoeia.
Steam Contaminant Limits
| Contaminant | Condensate | Steam Supply |
|---|---|---|
| Residue | Less than 10mg/kg | Less than 100mg/L |
| Heavy Metals | Not exceeding the limits for purified water in the Chinese Pharmacopoeia | Not exceeding the limits for purified water in the Chinese Pharmacopoeia |
| Chlorides | Less than 1mg/kg | Less than 10mg/L |
| Conductivity | Less than 15?S/cm | Less than 50?S/cm |
| pH | 5–8.5 | 5–8.5 |
| Appearance | Colorless | Colorless |
Note 1: If the contaminant levels in the feedwater or steam exceed the above limits, the sterilizer’s service life will be significantly reduced.
Process Air For Sterilization
The air used in the sterilizer should be dried and filtered to ensure the service life and filtering performance of the ETO Sterilization sterilizer’s terminal filter.
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