Sterile Test Isolator
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| Brand | PEA |
|---|---|
| Origin | Germany |
| Model | PEA VHP Series |
| Sterilization Agent | Vaporized Hydrogen Peroxide (VHP) |
| Sterility Assurance Level (SAL) | ≤10⁻⁶ |
| Log Reduction | ≥6-log against Geobacillus stearothermophilus (ATCC 12980 / ATCC 7953) |
| Filtration Class | ISO 14644-1 Class 5 (H14 HEPA) |
| Cycle Time | ~60 min |
| Operating Conditions | Ambient pressure, low-temperature (≤35 °C) |
| Decomposition Byproducts | H₂O and O₂ only |
| Compliance | EU GMP Annex 1, US FDA 21 CFR Part 11, ISO 14644, ISO 15883, EN 17175 |
| Brand | Tailin |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Direct Manufacturer |
| Product Origin | Domestic (China) |
| Model | GIT-WLAN |
| Price Range | USD 14,000 – 28,000 |
| Test Duration | 7 min |
| Continuous Operation Time | ≥2 h |
| Inflation Pressure Range | 500–3000 Pa |
| Pressure Resolution | 0.1 Pa |
| Communication | Wi-Fi |
| Offline Data Storage Capacity | 5000 test records |
| Battery | 12 V Li-ion |
| Power Consumption | ≤20 W |
| Compliance | GB/T 25915.7–2010 / ISO 14644-7:2004 |
| Software Compliance | FDA 21 CFR Part 11 |
| Brand | Tailin |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Manufacturer |
| Product Category | Domestic |
| Model | HTY Series |
| Pricing | Upon Request |
| Brand | Telstar |
|---|---|
| Origin | Spain |
| Model | Telstar Pura 2, Pura 3, Pura 4, Pura 3+, Pura 4+ |
| Air Classification | ISO Class 5 (EU GMP Grade A) in all chambers |
| Airflow | Unidirectional laminar flow (certified per ISO 14644-1) |
| Illumination | 700 lux (test chamber), 300 lux (transfer chamber) |
| Noise Level | <70 dBA |
| Inlet Filtration | HEPA H14 (99.997% @ 0.3 µm) |
| Exhaust Filtration | HEPA H14 (99.997% @ 0.3 µm) |
| Pre-filter | E10 |
| Bio-decontamination Efficacy | ≥6-log reduction of Geobacillus stearothermophilus spores |
| Sterility Test Pump | Integrated with standard Millipore (Merck) or Sartorius filtration units |
| Non-viable Particle Monitoring | APEX P5 portable airborne particle counter (dual-channel, 0.3/0.5 µm, 3000-record memory, 3.5" color touchscreen, stainless steel 304 housing) with LMS Express software (21 CFR Part 11 compliant) |
| Viable Microbial Monitoring | Sartorius MD8 airscan with gelatin membrane filtration |
| H₂O₂ Monitoring | In-chamber single-channel sensor (0–300 ppm) |
| Validation Support | FAT/SAT/DQ/IQ/OQ/PQ documentation templates available |
| Service | Global technical support via Telstar UK |
| Brand | Toone |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | TW-FGL2134 |
| Pricing | Upon Request |