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| 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 |
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