Technical Requirements for Parametric Release in EO Sterilization
Cov lus qhia raws li GB / Z 44877-2024 thiab GB 18279-2023
1. Cov cuab yeej tswj thiab saib xyuas muaj peev xwm
Ntxiv nrog rau qhov yuav tsum tau muaj ntawm GB 18279-2023 Tshooj 10, cov cuab yeej yuav tsum muaj cov peev txheej hauv qab no rau kev tso tawm parametric:
- Airflow Management: Cov chav ua ntej cua txias, sterilizers, thiab chav aeration yuav tsum tau nruab nrog cov cuab yeej cua ncig, anemometers, lossis lwm yam kev ntsuas los saib xyuas cov huab cua sab hauv.
- Humidity: Kev ntsuas ncaj qha ntawm chamber humidity thaum lub sijhawm kho.
- Concentration: Kev ntsuas ncaj qha ntawm Ethylene Oxide (EO) concentration ntawm cov ntu ntu thaum raug.
- Kub: Saib xyuas yam tsawg kawg ntawm ob qhov chaw ywj pheej nyob rau hauv lub chamber.
Tag nrho cov kev soj ntsuam thiab kaw cov tshuab yuav tsum tau txhais, tus yam ntxwv, thiab cov ntaub ntawv. Kev tso kawm sensor yuav tsum yog tus sawv cev ntawm lub xeev chamber.
2. Qhov tseem ceeb Parameter Specifications
2.1 Humidity Saib Xyuas
Cov av noo tuaj yeem ntsuas tau raws li txheeb ze humidity (RH) lossis Absolute Humidity.
- txheeb ze humidity: Feem ntau ntsuas siv capacitance zaj duab xis tshuab los txiav txim siab vapor siab ntom ntom ntawm qhov ntsuas kub.
- Absolute Humidity: Ntsuas dej concentration nyob rau hauv ib lub ntim ntawm huab cua, feem ntau siv spectroscopic cov tswv yim.
- Calibration: Electronic RH sensors (capacitance film) yuav tsum tau calibrated siv saturated ntsev tov los yog ntawv pov thawj RH tiam systems.
2.2 Ethylene Oxide (EO) Concentration
Qhov tseeb thiab qhov tseeb ntawm EO ntsuas qhov system yuav tsum tau sau tseg. Ob txoj hauv kev tseem ceeb yog siv:
| Technology | Mechanism |
|---|---|
| Spectroscopy (IR) | Ntsuas infrared lub teeb nqus los ntawm EO molecules. |
| Gas Chromatography (GC) | Sib cais EO ntawm ib sab thiab ntsuas qhov concentration ntawm tus qauv nkhaus. |
Rau kev ntsuas tawm sab nraum lub chamber, cov ntsiab lus ntxiv yuav tsum tau hais txog:
- Cov yeeb nkab ntev thiab cov khoom siv sib xws (piv txwv li, cov qib stainless hlau tshwj xeeb).
- Kev muaj peev xwm tawm ntawm cov ntsiab lus txuas.
- Thaum tshav kub kub Tracing: Rwb thaiv tsev ntawm cov kab sampling kom txo qis kev pheej hmoo ntawm EO lossis dej vapor.
- Mechanical rho tawm (twj los yog kiv cua) los ntawm lub chamber.
2.3 Kev ntsuas kub
Kev sib raug zoo hauv kev ntsuas yog xav tau rau ob qho tib si parametric thiab biological qhia tso tawm. Parametric tso tawm yuav tsum tau tsawg kawg yog ob qhov chaw saib xyuas kev ywj pheej.
3. Txheej txheem txhais thiab kev ua tau zoo (PQ)
- Yam tsawg kawg nkaus Specifications: Tsim los ntawm kev tshawb fawb microbial thiab lub cev PQ kom ntseeg tau tias yuav tsum muaj Sterility Assurance Level (SAL).
- Maximum Specifications: Tsim los xyuas kom meej cov khoom muaj kev nyab xeeb, zoo, thiab kev ua tau zoo thaum txo qis EO seem (ib GB / T 16886.7).
- Lub voj voog ntawm qis dua ntawm cov txheej txheem tsis (humidity, temp, EO) kom paub meej tias tsis muaj menyuam.
- Lub voj voog ntawm sab sauv txwv los soj ntsuam cov khoom / ntim kev ua haujlwm thiab EO residual qib.