Pharmsteri
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| Brand | Pharmsteri |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Import Status | Imported |
| Model | InVue GV148 |
| Product Type | Online Refractometer |
| Temperature Control | None |
| Digital Display | Yes |
| Measurement Range | 1.32–1.40 nD |
| Accuracy | ±3×10⁻⁶ nD (@20°C in DI water) |
| Brand | Pharmsteri |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Product Category | Imported |
| Model | PSTT-PTFE |
| Price | USD 5000 (FOB) |
| Membrane Material | Hydrophobic Polytetrafluoroethylene (PTFE) |
| Support & Housing Components | Polypropylene (PP) |
| Seal Material | Silicone |
| Bonding Method | Solvent-Free Thermal Bonding |
| Filtration Rating | 0.22 µm |
| Effective Filtration Area | ≥0.28 m² (5″), ≥0.58 m² (10″) |
| Bubble Point (60% IPA/H₂O, 25°C) | ≥1155 mbar |
| Bubble Point (95% EtOH/H₂O, 25°C) | ≥1100 mbar |
| Water Intrusion Test (2620 mbar, 25°C) | ≤1.0 mL/min (5″), ≤1.4 mL/min (10″) |
| Max Forward Differential Pressure | 4.2 bar (25°C), 2.0 bar (80°C) |
| Sterilization Cycles | 25× SIP at 127°C (30 min, forward/reverse) or autoclave |
| Endotoxin Release | <0.25 EU/mL (USP <85>) |
| TOC Leachables | <0.5 mg/L after 5 L rinse (10″) |
| Conductivity Leachables | ≤1.3 µS/cm after 5 L rinse (10″) |
| Non-Fiber Shedding | Compliant with 21 CFR 210.3(b)(6) |
| Biocompatibility | USP <87> In Vitro Cytotoxicity & USP <88> Class VI Plastic Testing |
| Bacterial Challenge | ASTM F838–22 with Brevundimonas diminuta (≥1×10⁷ CFU/cm²) |
| Regulatory Compliance | FDA 21 CFR Parts 210/211, USP <1211>, ISO 9001 & ISO 13485 QMS, EU Food Contact Regulations (EC) No. 1935/2004 & (EU) No. 10/2011, WFI-grade compliance per USP <1231> |