Goldy Homes
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System Overview: Introducing our state-of-the-art aseptic mixing isolation system, crafted specifically for both multi-component and single-component dosing, mixing, and secondary filling post container loading. Equipped with ISPE-recommended RABS protection, the critical operation area ensures optimal safety. Seamlessly interfaced with a vaporized hydrogen peroxide (VHP) pass-through window, the system excels in self-cleaning and manual aluminum lid opening.
System Performance Characteristics:
| No. | Item | Parameter |
|---|---|---|
| 1 | Cavity Cleanliness | Grade A Positive Pressure Laminar Flow |
| 2 | Air Volume | 85-500m3/h |
| 3 | HEPA Filter Type–Inlet Air | HEPA High-Efficiency Air Filter, H14 Type |
| 4 | Air Velocity | 0.45m/s ±20% |
| 5 | Quantity of gloves | As required |
| 6 | VHP concentration | 0-5000 ppm |
| 7 | Biological indicator | 6 log reduction including VHP sterilization |
| 8 | Sterilization time | 20-60min |
| 9 | Leakage rate | 0.5 % vol/h @100 Pa |
| 10 | Noise level | ≤65 dBA |
Our facility houses over 100 state-of-the-art automated production and processing machines, seamlessly integrated across all manufacturing stages. Supported by experienced engineers and skilled technicians, our products are trusted by pharmaceutical giants worldwide.
