General Processing Platform Isolator (GPPI) Start up Operation | Esco Pharma
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- Опубликовано: 24 авг 2024
- Esco shares these steps on how to start up the operation of a General Processing Platform Isolator (GPPI).
1. Power up the equipment
2. Log-in as user/operator
3. Press the power reset button to access the main operations screen.
4. Open the chamber in preparation for loading the items.
5. Load all the items needed inside the isolator.
6. Before starting a normal run operation, perform a Pressure Decay Test and decontaminate the isolator. Log in to the system to access the operations screen as it has been idle for 5 mins. Start Pressure Decay Test. At this stage, all dampers are closing as the isolator stabilizes. Air is injected inside the isolator to reach 250 Pa. Once 250 Pa, is achieved, the Pressure Decay Test starts and will end after 5 minutes.
7. After 5 mins, if chamber pressure loss is less than 42 Pa, the test Passed.
Biodecontamination Process:
1. Load the hydrogen peroxide bottle inside the BioVap TM decontamination system.
2. Open the pass chamber inner door.
3. Carefully install all the glove stretchers.
4. Start the Biodecontamination cycle.
5. Press the start/stop button to start the operation. The Esco BioVap™ system is not affected by temperature and relative humidity, therefore pre-conditioning of the chamber is not required. 6. The Esco BioVap TM will start atomizing the hydrogen peroxide sterilant creating a dry fog.
7. Gassing/injection will take about 30 seconds to 5 minutes. Hydrogen peroxide sterilant is being maintained at this stage to ensure exposure to all internal volumes of the chamber. 8. Hydrogen peroxide sterilant is removed from the chamber in this stage called Aeration.
9. Biodecontamination process is completed once the hydrogen peroxide concentration is less than 1.0 ppm. Once completed and the unit has Passed, close the pass chamber inner door.
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