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Ophthalmic Eye Sphere and Conformer Sterilization Instructions |
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| Gulden Ophthalmics Eye Spheres and Conformers are non sterile. Eye Spheres and Conformers may be sterilized with ethylene oxide (EtO) under the following conditions:
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Temperature
Pre-Vacuum
Relative Humidity
Humidty Dwell
Sterilant Gas
EtO Concentrate
Exposure time
Post Vacuum (2 times)
Mechanical Aeration temperature
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130 ± 5°F / 54 ± 3°C
24 - 26 inHg / 610 - 660 mmHg
60 ± 10% RH
30 - 45 minutes
100 % EtO
600 ± 30 mg/Liter
2 hours ± 5 minute
24 - 25 inHg / 610 - 660 mmHg
110 - 124°F / 43 - 51°C
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Residuals after 48 hours minimal Aeration time
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EO < 250ppm
ECH < 250ppm
EGly < 5000ppm
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Residuals after 72 hours recommended Aeration time
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EO < 250ppm
ECH < 250ppm
EGly < 5000ppm
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Sterility assurance level (SAL) of 10-6 was achieved for Gulden eye spheres and conformers when processed according to STERRAD's instructions through a short full cycle in the STERRAD 100S Sterilization System.
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