Parametric Release thiab Sterile Product Release Protocols
High-precision EO Sterilization Chamber rau Parametric Tso Cai Ua Raws Cai.
1. Kev soj ntsuam muaj peev xwm rau kev tso tawm Parametric
Raws li GB/Z 44877-2024 thiab GB 18279-2023, cov cuab yeej siv rau kev tso tawm parametric yuav tsum dhau qhov kev soj ntsuam tus qauv. Qhov no suav nrog:
- Airflow Monitoring: Yuav tsum tau teeb tsa cov cuab yeej siv cua tshuab thiab anemometers hauv pre-conditioning, sterilization, thiab aeration chambers.
- Direct Humidity: Kev ntsuas lub sijhawm tiag tiag thaum lub sijhawm kho.
- EO Concentration: Kev ntsuas ncaj qha ntawm txhua lub sijhawm xav tau thaum raug.
- Dual Temperature Points: Yam tsawg kawg yog ob qhov chaw muaj kev ywj pheej uas sawv cev rau lub xeev chamber.
1.1 Sensor yees & Calibration
Kev ntsuas av noo
Ntsuas ntawm Capacitance Zaj duab xis (Relative Humidity) los yog Spectroscopy (Txoj Kev Humidity). Sensors yuav tsum tau calibrated siv saturated ntsev tov thiab tiv thaiv los ntawm EO-induced drift los ntawm nquag validation los yog thermal rho tawm.
Integrated Humidity thiab EO Concentration Monitoring Systems.
EO Concentration (Spectroscopy & GC)
Qhov tseeb thiab qhov tseeb yuav tsum tau sau tseg. IR Spectroscopy (Infrared absorption) los yog Gas Chromatography (GC) yog cov txheej txheem txheem. Cov kab sampling sab nraud yuav tsum siv Thaum tshav kub kub Tracing tiv thaiv condensation.
2. Kev tso tawm cov khoom tsis muaj menyuam (Tshooj 11)
2.1 Cov Cai rau Kev Tshaj Tawm Parametric
Kev tso tawm tsis tu ncua yog ua raws nkaus xwb lub cev ua tsis tau lub rooj sib tham tsim cov specifications thaum lub sij hawm validation. Tsis zoo li cov txheej txheem ib txwm muaj, nws tsis vam khom rau qhov ntsuas tshuaj lom neeg (BI) cov txiaj ntsig. Kev tshuaj xyuas cov ntaub ntawv los ntawm cov neeg ua haujlwm tau tso cai yog yuav tsum tau ua.
Cov ntaub ntawv tshuaj xyuas thiab lub cev Parameter tswj rau Batch tso tawm.
2.2 Sensor kev ncaj ncees thiab raug
Yog tias kev tswj xyuas lossis kev saib xyuas cov sensors tsis ua raws li cov lus qhia tshwj xeeb, lossis yog tias qhov kev tshawb nrhiav tsis tuaj yeem lees paub qhov tseeb ntawm chamber nyeem, load yuav tsum suav hais tias tsis ua raws.
3. Kev sib txawv thiab kev tshawb nrhiav
3.1 Cov Ntaub Ntawv Qhia Tawm Tawm (OOS).
Thaum tsis muaj ntau tshaj qhov txwv, kev tshawb nrhiav yuav tsum txiav txim siab qhov laj thawj. Cov khoom yuav tsum raug cais tawm kom txog thaum kev ntsuam xyuas kev nyab xeeb tiav.
Load yam ntxwv: Yog tias EO lossis cov ntaub ntawv av noo yog OOS thaum tswj tau zoo, ntsuas qhov loading qauv. Qhov sib txawv ntawm kev nqus piv rau qhov pib PQ load tuaj yeem yog qhov ua rau.
3.2 Kev Kho Kom Zoo Thiab Tshaj Tawm
Yog tias lub sensor tsis ua haujlwm, cov txheej txheem yuav rov qab mus rau ib ntus Kev Tshaj Tawm Txog Kev Siv Tshuaj lom neeg thaum kho. Kev tso tawm Parametric tuaj yeem rov pib dua tsuas yog tom qab kho khoom siv thiab rov kho dua.
Calibration thiab Maintenance kom ntseeg tau tias Sensor Precision rau Nruam Parametric Tso Tawm.
Nco ntsoov: Cov txheej txheem uas ua tsis tiav parametric tso tawm specifications yuav tsum tsis txhob raug tso tawm raws li cov txiaj ntsig BI ua tiav. Tsis tas li ntawd, kev tso tawm parametric tsis tuaj yeem siv los hla qhov kev xeem BI ua tsis tiav.