Farmasötik İzolatörler için Şişirilebilir Contalar
$5-10 /
| Min. sipariş: | 1 |
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| Cleanroom | ISO 5 / Class A laminar flow |
| Sterilization | VHP approx. 35% H2O2; optional SIP 121-134 C |
| Pressure | Inflation 0.2-0.6 MPa; differential +/-50-250 Pa |
| Media | VHP gas, IPA, purified water / WFI, detergents |
| Cycles | 20-80 per day, up to 200 on busy hatches |
| Surface | Ra max. 0.8 um, radii min. R3 mm, no crevices |
| Material | Rating | Notes |
|---|---|---|
| Platinum-cured silicone VMQ | Recommended | No peroxide residues, low extractables and absorption; -60 to +200 C; 50 +/-5 Shore A; white for visual cleanliness checks; USP Class VI, ISO 10993 |
| Fluorosilicone FVMQ | Alternative | Better for heavy IPA wiping; higher cost |
| White EPDM | Optional | Where VHP is not used; shorter life |
| NBR / standard silicone | Not advised | Unlikely to meet USP Class VI |
| Test | Result |
|---|---|
| 0.4 MPa, 60 min pressure decay | Leak rate below 0.5 mbar L/s |
| VHP, 500 sterilization cycles | Hardness change max. 3 Shore A |
| SIP 134 C / 30 min, 100 cycles | Compression set max. 15% |
| Fatigue, 0.4 MPa inflate and deflate | 500,000 cycles, no leakage |
| Deflation, 0.4 MPa to 0 | Under 2 s |
| USP <87> / <88> | Reactivity below grade 1 |
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